Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2026-01-08 @ 6:41 AM
Study NCT ID:
NCT00762359
Status:
TERMINATED
Last Update Posted:
2012-02-03
First Post:
2008-09-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Safety and Efficacy Study of Lansoprazole in Preventing Aspirin-Induced Gastric and Duodenal Ulcers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013276', 'term': 'Stomach Ulcer'}, {'id': 'D004381', 'term': 'Duodenal Ulcer'}], 'ancestors': [{'id': 'D010437', 'term': 'Peptic Ulcer'}, {'id': 'D004378', 'term': 'Duodenal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064747', 'term': 'Lansoprazole'}, {'id': 'D005778', 'term': 'Gefarnate'}], 'ancestors': [{'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrialregistry@tpna.com', 'phone': '800-778-2860', 'title': 'Sr. VP Clinical Science', 'organization': 'Takeda Global Research and Development Center, Inc.'}, 'certainAgreement': {'otherDetails': 'The clinical trial contract states that information should never be disclosed without prior consent of the sponsor, although it does not specify the number of days during which disclosure of information is limited.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'On September 2008, the Efficacy and Safety Evaluation Committee recommended that this study be discontinued based on the interim analysis.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.', 'description': 'At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Lansoprazole 15 mg QD', 'description': 'Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.', 'otherNumAtRisk': 226, 'otherNumAffected': 82, 'seriousNumAtRisk': 226, 'seriousNumAffected': 27}, {'id': 'EG001', 'title': 'Gefarnate 50 mg BID', 'description': 'Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.', 'otherNumAtRisk': 234, 'otherNumAffected': 68, 'seriousNumAtRisk': 234, 'seriousNumAffected': 26}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Reflux oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 45}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 9}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': 'Colonic polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gastric ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Alcoholic pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Subileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Colitis ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gastritis haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Duodenal ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Small intestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Liver disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Corneal degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Sudden hearing loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Meniscus lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hemiplegia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Bile duct cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pharyngeal cancer stage unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Breast cancer female', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Oesophageal carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Large intestine carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Gastric Ulcer and/or Duodenal Ulcer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lansoprazole 15 mg QD', 'description': 'Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.'}, {'id': 'OG001', 'title': 'Gefarnate 50 mg BID', 'description': 'Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0989', 'ciLowerLimit': '0.0425', 'ciUpperLimit': '0.2300', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '18 Months', 'description': 'The number of participants that developed gastric ulcer and/or duodenal ulcer at month 18 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants not taking investigational drug were not included.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lansoprazole 15 mg QD', 'description': 'Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.'}, {'id': 'OG001', 'title': 'Gefarnate 50 mg BID', 'description': 'Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.150', 'spread': '0.904', 'groupId': 'OG000'}, {'value': '0.460', 'spread': '1.241', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 3.', 'description': 'The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and \\<1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves \\>6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect \\< 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Values are from the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lansoprazole 15 mg QD', 'description': 'Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.'}, {'id': 'OG001', 'title': 'Gefarnate 50 mg BID', 'description': 'Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.153', 'spread': '1.172', 'groupId': 'OG000'}, {'value': '0.530', 'spread': '1.444', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Month 6.', 'description': 'The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and \\<1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves \\>6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect \\< 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Values are from the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lansoprazole 15 mg QD', 'description': 'Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.'}, {'id': 'OG001', 'title': 'Gefarnate 50 mg BID', 'description': 'Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.149', 'spread': '1.157', 'groupId': 'OG000'}, {'value': '0.419', 'spread': '1.375', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0079', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 9.', 'description': 'The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and \\<1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves \\>6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect \\< 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Values are from the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lansoprazole 15 mg QD', 'description': 'Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.'}, {'id': 'OG001', 'title': 'Gefarnate 50 mg BID', 'description': 'Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.224', 'spread': '1.112', 'groupId': 'OG000'}, {'value': '0.205', 'spread': '1.047', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0433', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 12.', 'description': 'The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and \\<1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves \\>6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect \\< 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Values are from the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lansoprazole 15 mg QD', 'description': 'Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.'}, {'id': 'OG001', 'title': 'Gefarnate 50 mg BID', 'description': 'Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 18.', 'description': 'The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and \\<1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves \\>6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect \\< 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lansoprazole 15 mg QD', 'description': 'Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.'}, {'id': 'OG001', 'title': 'Gefarnate 50 mg BID', 'description': 'Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.132', 'spread': '0.552', 'groupId': 'OG000'}, {'value': '0.228', 'spread': '0.755', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 3.', 'description': 'The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and \\< 1 lesion; 2= 2 to 5 lesions ; 3= \\> 6 lesions). Erosions are defined as mucosal defect \\< 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Values are from the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lansoprazole 15 mg QD', 'description': 'Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.'}, {'id': 'OG001', 'title': 'Gefarnate 50 mg BID', 'description': 'Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.165', 'spread': '0.583', 'groupId': 'OG000'}, {'value': '0.149', 'spread': '0.741', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0006', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 6.', 'description': 'The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and \\< 1 lesion; 2= 2 to 5 lesions ; 3= \\> 6 lesions). Erosions are defined as mucosal defect \\< 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Values are from the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lansoprazole 15 mg QD', 'description': 'Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.'}, {'id': 'OG001', 'title': 'Gefarnate 50 mg BID', 'description': 'Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.092', 'spread': '0.542', 'groupId': 'OG000'}, {'value': '0.216', 'spread': '0.688', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0025', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 9.', 'description': 'The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and \\< 1 lesion; 2= 2 to 5 lesions ; 3= \\> 6 lesions). Erosions are defined as mucosal defect \\< 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Values are from the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lansoprazole 15 mg QD', 'description': 'Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.'}, {'id': 'OG001', 'title': 'Gefarnate 50 mg BID', 'description': 'Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.254', 'spread': '0.766', 'groupId': 'OG000'}, {'value': '0.136', 'spread': '0.409', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0010', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 12.', 'description': 'The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and \\< 1 lesion; 2= 2 to 5 lesions ; 3= \\> 6 lesions). Erosions are defined as mucosal defect \\< 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Values are from the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lansoprazole 15 mg QD', 'description': 'Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.'}, {'id': 'OG001', 'title': 'Gefarnate 50 mg BID', 'description': 'Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 18.', 'description': 'The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and \\< 1 lesion; 2= 2 to 5 lesions ; 3= \\> 6 lesions). Erosions are defined as mucosal defect \\< 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Gastric or Duodenal Ulcer or Gastric or Duodenal Hemorrhagic Lesion (Upper Gastrointestinal Hemorrhage)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lansoprazole 15 mg QD', 'description': 'Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.'}, {'id': 'OG001', 'title': 'Gefarnate 50 mg BID', 'description': 'Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '18 Months', 'description': 'Number of participants with gastric or duodenal ulcer or gastric or duodenal hemorrhagic lesion (upper gastrointestinal hemorrhage) from baseline through month 18 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Values are from the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lansoprazole 15 mg QD', 'description': 'Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.'}, {'id': 'OG001', 'title': 'Gefarnate 50 mg BID', 'description': 'Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.005', 'spread': '0.187', 'groupId': 'OG000'}, {'value': '0.015', 'spread': '0.295', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6148', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 3.', 'description': 'Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Values are from the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lansoprazole 15 mg QD', 'description': 'Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.'}, {'id': 'OG001', 'title': 'Gefarnate 50 mg BID', 'description': 'Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.025', 'spread': '0.158', 'groupId': 'OG000'}, {'value': '-0.030', 'spread': '0.171', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8050', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 6.', 'description': 'Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Values are from the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lansoprazole 15 mg QD', 'description': 'Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.'}, {'id': 'OG001', 'title': 'Gefarnate 50 mg BID', 'description': 'Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.027', 'spread': '0.163', 'groupId': 'OG000'}, {'value': '-0.023', 'spread': '0.152', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8678', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 9.', 'description': 'Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Values are from the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lansoprazole 15 mg QD', 'description': 'Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.'}, {'id': 'OG001', 'title': 'Gefarnate 50 mg BID', 'description': 'Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.020', 'spread': '0.143', 'groupId': 'OG000'}, {'value': '-0.071', 'spread': '0.262', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2688', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 12.', 'description': 'Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Values are from the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lansoprazole 15 mg QD', 'description': 'Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.'}, {'id': 'OG001', 'title': 'Gefarnate 50 mg BID', 'description': 'Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.333', 'spread': '0.577', 'groupId': 'OG000'}, {'value': '-1.000', 'spread': 'NA', 'comment': 'No test was performed when the number of cases was 5 or less.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 18.', 'description': 'Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lansoprazole 15 mg QD', 'description': 'Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.'}, {'id': 'OG001', 'title': 'Gefarnate 50 mg BID', 'description': 'Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.005', 'spread': '0.307', 'groupId': 'OG000'}, {'value': '0.026', 'spread': '0.357', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7054', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 3.', 'description': 'Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). 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Higher scores indicate greater severity of gastrointestinal symptom.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Values are from the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lansoprazole 15 mg QD', 'description': 'Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.'}, {'id': 'OG001', 'title': 'Gefarnate 50 mg BID', 'description': 'Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No test was performed when the number of cases was 5 or less.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No test was performed when the number of cases was 5 or less.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 18.', 'description': 'Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lansoprazole 15 mg QD', 'description': 'Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.'}, {'id': 'OG001', 'title': 'Gefarnate 50 mg BID', 'description': 'Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.005', 'spread': '0.254', 'groupId': 'OG000'}, {'value': '0.010', 'spread': '0.175', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6175', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 3.', 'description': 'Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Values are from the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lansoprazole 15 mg QD', 'description': 'Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.'}, {'id': 'OG001', 'title': 'Gefarnate 50 mg BID', 'description': 'Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.019', 'spread': '0.177', 'groupId': 'OG000'}, {'value': '0.000', 'spread': '0.246', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4496', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 6.', 'description': 'Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Values are from the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lansoprazole 15 mg QD', 'description': 'Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.'}, {'id': 'OG001', 'title': 'Gefarnate 50 mg BID', 'description': 'Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.018', 'spread': '0.190', 'groupId': 'OG000'}, {'value': '0.000', 'spread': '0.153', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4718', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 9.', 'description': 'Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Values are from the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lansoprazole 15 mg QD', 'description': 'Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.'}, {'id': 'OG001', 'title': 'Gefarnate 50 mg BID', 'description': 'Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.000', 'spread': '0.204', 'groupId': 'OG000'}, {'value': '-0.036', 'spread': '0.189', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4484', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 12.', 'description': 'Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Values are from the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lansoprazole 15 mg QD', 'description': 'Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.'}, {'id': 'OG001', 'title': 'Gefarnate 50 mg BID', 'description': 'Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.333', 'spread': '0.577', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No test was performed when the number of cases was 5 or less.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 18.', 'description': 'Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lansoprazole 15 mg QD', 'description': 'Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.'}, {'id': 'OG001', 'title': 'Gefarnate 50 mg BID', 'description': 'Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.010', 'spread': '0.099', 'groupId': 'OG000'}, {'value': '0.020', 'spread': '0.286', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2604', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 3.', 'description': 'Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Values are from the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lansoprazole 15 mg QD', 'description': 'Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.'}, {'id': 'OG001', 'title': 'Gefarnate 50 mg BID', 'description': 'Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.006', 'spread': '0.138', 'groupId': 'OG000'}, {'value': '0.000', 'spread': '0.123', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6818', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 6.', 'description': 'Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Values are from the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lansoprazole 15 mg QD', 'description': 'Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.'}, {'id': 'OG001', 'title': 'Gefarnate 50 mg BID', 'description': 'Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.009', 'spread': '0.165', 'groupId': 'OG000'}, {'value': '-0.012', 'spread': '0.108', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9015', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 9.', 'description': 'Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Values are from the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lansoprazole 15 mg QD', 'description': 'Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.'}, {'id': 'OG001', 'title': 'Gefarnate 50 mg BID', 'description': 'Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.020', 'spread': '0.143', 'groupId': 'OG000'}, {'value': '0.000', 'spread': '0.000', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4497', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 12.', 'description': 'Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Values are from the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lansoprazole 15 mg QD', 'description': 'Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.'}, {'id': 'OG001', 'title': 'Gefarnate 50 mg BID', 'description': 'Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No test was performed when the number of cases was 5 or less.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No test was performed when the number of cases was 5 or less.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 18.', 'description': 'Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lansoprazole 15 mg QD', 'description': 'Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.'}, {'id': 'OG001', 'title': 'Gefarnate 50 mg BID', 'description': 'Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.'}], 'classes': [{'title': 'Adverse event', 'categories': [{'measurements': [{'value': '166', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}]}, {'title': 'Adverse event (Frequency ≥5%)', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}]}, {'title': 'Adverse event related to the study drug', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Serious adverse event', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Serious adverse event related to the study drug', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '18 Months', 'description': 'Treatment-emergent adverse events (TEAE) are adverse events with an onset that occurs after receiving study drug. A TEAE may also be a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing. Please see Other Adverse Events table below for TEAE listings.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lansoprazole 15 mg QD', 'description': 'Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.'}, {'id': 'FG001', 'title': 'Gefarnate 50 mg BID', 'description': 'Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '226'}, {'groupId': 'FG001', 'numSubjects': '235'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '167'}, {'groupId': 'FG001', 'numSubjects': '178'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '57'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Institution closed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Removal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were enrolled at sites in Japan from May 2007 to November 2008.', 'preAssignmentDetails': 'Participants were enrolled in either lansoprazole, once daily (QD) or gefarnate, twice daily (BID) treatment groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'BG000'}, {'value': '235', 'groupId': 'BG001'}, {'value': '461', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lansoprazole 15 mg QD', 'description': 'Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.'}, {'id': 'BG001', 'title': 'Gefarnate 50 mg BID', 'description': 'Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<=39 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Between 40 and 49 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Between 50 and 59 years', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}, {'title': 'Between 60 and 64 years', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}, {'title': 'Between 65 and 69 years', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}]}, {'title': 'Between 70 and 79 years', 'categories': [{'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '186', 'groupId': 'BG002'}]}]}, {'title': '<=80 years', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '175', 'groupId': 'BG000'}, {'value': '192', 'groupId': 'BG001'}, {'value': '367', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '226', 'groupId': 'BG000'}, {'value': '235', 'groupId': 'BG001'}, {'value': '461', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 461}}, 'statusModule': {'whyStopped': 'AG-1749 superior to Gefarnate in ulcer prevention', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-01', 'studyFirstSubmitDate': '2008-09-26', 'resultsFirstSubmitDate': '2011-02-03', 'studyFirstSubmitQcDate': '2008-09-29', 'lastUpdatePostDateStruct': {'date': '2012-02-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-04-11', 'studyFirstPostDateStruct': {'date': '2008-09-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-05-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Gastric Ulcer and/or Duodenal Ulcer', 'timeFrame': '18 Months', 'description': 'The number of participants that developed gastric ulcer and/or duodenal ulcer at month 18 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)', 'timeFrame': 'Baseline and Month 3.', 'description': 'The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and \\<1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves \\>6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect \\< 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.'}, {'measure': 'Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)', 'timeFrame': 'Baseline and Month 6.', 'description': 'The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and \\<1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves \\>6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect \\< 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.'}, {'measure': 'Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 9)', 'timeFrame': 'Baseline and Month 9.', 'description': 'The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and \\<1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves \\>6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect \\< 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.'}, {'measure': 'Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)', 'timeFrame': 'Baseline and Month 12.', 'description': 'The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and \\<1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves \\>6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect \\< 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.'}, {'measure': 'Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)', 'timeFrame': 'Baseline and Month 18.', 'description': 'The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and \\<1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves \\>6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect \\< 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.'}, {'measure': 'Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)', 'timeFrame': 'Baseline and Month 3.', 'description': 'The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and \\< 1 lesion; 2= 2 to 5 lesions ; 3= \\> 6 lesions). Erosions are defined as mucosal defect \\< 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.'}, {'measure': 'Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)', 'timeFrame': 'Baseline and Month 6.', 'description': 'The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and \\< 1 lesion; 2= 2 to 5 lesions ; 3= \\> 6 lesions). Erosions are defined as mucosal defect \\< 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.'}, {'measure': 'Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 9)', 'timeFrame': 'Baseline and Month 9.', 'description': 'The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and \\< 1 lesion; 2= 2 to 5 lesions ; 3= \\> 6 lesions). Erosions are defined as mucosal defect \\< 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.'}, {'measure': 'Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)', 'timeFrame': 'Baseline and Month 12.', 'description': 'The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and \\< 1 lesion; 2= 2 to 5 lesions ; 3= \\> 6 lesions). Erosions are defined as mucosal defect \\< 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.'}, {'measure': 'Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)', 'timeFrame': 'Baseline and Month 18.', 'description': 'The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and \\< 1 lesion; 2= 2 to 5 lesions ; 3= \\> 6 lesions). Erosions are defined as mucosal defect \\< 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.'}, {'measure': 'Number of Participants With Gastric or Duodenal Ulcer or Gastric or Duodenal Hemorrhagic Lesion (Upper Gastrointestinal Hemorrhage)', 'timeFrame': '18 Months', 'description': 'Number of participants with gastric or duodenal ulcer or gastric or duodenal hemorrhagic lesion (upper gastrointestinal hemorrhage) from baseline through month 18 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.'}, {'measure': 'Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 3)', 'timeFrame': 'Baseline and Month 3.', 'description': 'Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.'}, {'measure': 'Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 6)', 'timeFrame': 'Baseline and Month 6.', 'description': 'Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.'}, {'measure': 'Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 9)', 'timeFrame': 'Baseline and Month 9.', 'description': 'Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.'}, {'measure': 'Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 12)', 'timeFrame': 'Baseline and Month 12.', 'description': 'Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.'}, {'measure': 'Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 18)', 'timeFrame': 'Baseline and Month 18.', 'description': 'Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.'}, {'measure': 'Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 3)', 'timeFrame': 'Baseline and Month 3.', 'description': 'Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.'}, {'measure': 'Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 6)', 'timeFrame': 'Baseline and Month 6.', 'description': 'Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.'}, {'measure': 'Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 9)', 'timeFrame': 'Baseline and Month 9.', 'description': 'Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.'}, {'measure': 'Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 12)', 'timeFrame': 'Baseline and Month 12.', 'description': 'Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.'}, {'measure': 'Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 18)', 'timeFrame': 'Baseline and Month 18.', 'description': 'Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.'}, {'measure': 'Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 3)', 'timeFrame': 'Baseline and Month 3.', 'description': 'Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.'}, {'measure': 'Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 6)', 'timeFrame': 'Baseline and Month 6.', 'description': 'Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.'}, {'measure': 'Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 9)', 'timeFrame': 'Baseline and Month 9.', 'description': 'Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.'}, {'measure': 'Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 12)', 'timeFrame': 'Baseline and Month 12.', 'description': 'Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.'}, {'measure': 'Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 18)', 'timeFrame': 'Baseline and Month 18.', 'description': 'Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.'}, {'measure': 'Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 3)', 'timeFrame': 'Baseline and Month 3.', 'description': 'Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.'}, {'measure': 'Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 6)', 'timeFrame': 'Baseline and Month 6.', 'description': 'Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.'}, {'measure': 'Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 9)', 'timeFrame': 'Baseline and Month 9.', 'description': 'Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.'}, {'measure': 'Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 12)', 'timeFrame': 'Baseline and Month 12.', 'description': 'Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.'}, {'measure': 'Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 18)', 'timeFrame': 'Baseline and Month 18.', 'description': 'Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.'}, {'measure': 'Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 3)', 'timeFrame': 'Baseline and Month 3.', 'description': 'Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.'}, {'measure': 'Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 6)', 'timeFrame': 'Baseline and Month 6.', 'description': 'Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.'}, {'measure': 'Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 9)', 'timeFrame': 'Baseline and Month 9.', 'description': 'Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.'}, {'measure': 'Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 12)', 'timeFrame': 'Baseline and Month 12.', 'description': 'Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.'}, {'measure': 'Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 18)', 'timeFrame': 'Baseline and Month 18.', 'description': 'Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.'}, {'measure': 'Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 3)', 'timeFrame': 'Baseline and Month 3.', 'description': 'Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.'}, {'measure': 'Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 6)', 'timeFrame': 'Baseline and Month 6.', 'description': 'Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.'}, {'measure': 'Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 9)', 'timeFrame': 'Baseline and Month 9.', 'description': 'Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.'}, {'measure': 'Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 12)', 'timeFrame': 'Baseline and Month 12.', 'description': 'Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.'}, {'measure': 'Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 18)', 'timeFrame': 'Baseline and Month 18.', 'description': 'Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.'}, {'measure': 'Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 3)', 'timeFrame': 'Baseline and Month 3.', 'description': 'Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.'}, {'measure': 'Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 6)', 'timeFrame': 'Baseline and Month 6.', 'description': 'Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.'}, {'measure': 'Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 9)', 'timeFrame': 'Baseline and Month 9.', 'description': 'Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.'}, {'measure': 'Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 12)', 'timeFrame': 'Baseline and Month 12.', 'description': 'Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.'}, {'measure': 'Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 18)', 'timeFrame': 'Baseline and Month 18.', 'description': 'Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.'}, {'measure': 'Number of Participants With Adverse Events', 'timeFrame': '18 Months', 'description': 'Treatment-emergent adverse events (TEAE) are adverse events with an onset that occurs after receiving study drug. A TEAE may also be a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing. Please see Other Adverse Events table below for TEAE listings.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Curling Ulcer', 'Gastric Ulcer', 'Aspirin', 'Acetylsalicylic Acid', 'Drug Therapy'], 'conditions': ['Stomach Ulcer', 'Duodenal Ulcer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether lansoprazole, once daily (QD), compared to gefarnate, twice daily (BID), is effective in preventing the recurrence of gastric and duodenal ulcers in patients receiving long term treatment with low dosage aspirin.', 'detailedDescription': 'In Japan, low-dose aspirin is one of the commonly prescribed drugs for inhibiting thrombosis and thrombus formation after angina, myocardial infarction, ischemic cerebrovascular disease, coronary artery by-pass surgery and percutaneous transluminal coronary angioplasty in patients. While low-dose aspirin is effective in these cases, its use sometimes causes gastric and duodenal ulcers which can lead to gastrointestinal bleeding, and in worse cases may lead to death.\n\nThe purpose of this study is to assess the efficacy of lansoprazole versus gefarnate in patients with a history of gastric or duodenal ulcers receiving daily low dose aspirin therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient was on low-dose aspirin treatment on the day when consent was obtained, and requires the long-term continuous treatment even after treatment with the investigational drug is started.\n* The patient was confirmed to have a history of gastric ulcer or duodenal ulcer.\n\nExclusion Criteria:\n\n* Endoscopically confirmed gastric and/or duodenal ulcers on Day 1.\n* Endoscopically confirmed active upper gastrointestinal hemorrhage on Day 1.\n* Current or past history of aspirin-induced asthma or hypersensitivity to nonsteroidal anti-inflammatory drugs.\n* Past or planned surgery affecting gastric acid secretion.\n* Clinically significant hepatic or renal disorder.'}, 'identificationModule': {'nctId': 'NCT00762359', 'briefTitle': 'A Safety and Efficacy Study of Lansoprazole in Preventing Aspirin-Induced Gastric and Duodenal Ulcers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Study to Investigate the Preventive Effect of AG-1749 Against the Recurrence of Gastric And Duodenal Ulcers During Long-Term Treatment With Low Dose Aspirin.', 'orgStudyIdInfo': {'id': 'AG-1749-CCT-351'}, 'secondaryIdInfos': [{'id': '070494', 'type': 'REGISTRY', 'domain': 'JapicCTI'}, {'id': 'U1111-1113-9929', 'type': 'REGISTRY', 'domain': 'WHO'}, {'id': 'R100125', 'type': 'REGISTRY', 'domain': 'JapicCTI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lansoprazole 15 mg QD', 'interventionNames': ['Drug: Lansoprazole']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Gefarnate 50 mg BID', 'interventionNames': ['Drug: Gefarnate']}], 'interventions': [{'name': 'Lansoprazole', 'type': 'DRUG', 'otherNames': ['AG-1749', 'PREVACID®', 'Takepron®'], 'description': 'Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.', 'armGroupLabels': ['Lansoprazole 15 mg QD']}, {'name': 'Gefarnate', 'type': 'DRUG', 'description': 'Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.', 'armGroupLabels': ['Gefarnate 50 mg BID']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Matsudo-shi', 'state': 'Chiba', 'country': 'Japan'}, {'city': 'Yotsukaido-shi', 'state': 'Chiba', 'country': 'Japan'}, {'city': 'Imabari', 'state': 'Ehime', 'country': 'Japan', 'geoPoint': {'lat': 34.07001, 'lon': 133.00023}}, {'city': 'Matsuyama', 'state': 'Ehime', 'country': 'Japan', 'geoPoint': {'lat': 33.83916, 'lon': 132.76574}}, {'city': 'Fukui-shi', 'state': 'Fukui', 'country': 'Japan', 'geoPoint': {'lat': 36.06443, 'lon': 136.22257}}, {'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Onga-gun', 'state': 'Fukuoka', 'country': 'Japan'}, {'city': 'Gifu', 'state': 'Gifu', 'country': 'Japan', 'geoPoint': {'lat': 35.42291, 'lon': 136.76039}}, {'city': 'Fujioka-shi', 'state': 'Gunma', 'country': 'Japan'}, {'city': 'Maebashi', 'state': 'Gunma', 'country': 'Japan', 'geoPoint': {'lat': 36.4, 'lon': 139.08333}}, {'city': 'Higashihiroshima-shi', 'state': 'Hiroshima', 'country': 'Japan'}, {'city': 'Hiroshima', 'state': 'Hiroshima', 'country': 'Japan', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'city': 'Kure-shi', 'state': 'Hiroshima', 'country': 'Japan'}, {'city': 'Asahikawa-shi', 'state': 'Hokkaido', 'country': 'Japan'}, {'city': 'Hakodate-shi', 'state': 'Hokkaido', 'country': 'Japan'}, {'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Nishinomiya-shi', 'state': 'Hyōgo', 'country': 'Japan'}, {'city': 'Higashiibaraki-gun', 'state': 'Ibaraki', 'country': 'Japan'}, {'city': 'Hitachi-Naka', 'state': 'Ibaraki', 'country': 'Japan', 'geoPoint': {'lat': 36.39659, 'lon': 140.53479}}, {'city': 'Inashiki-gun', 'state': 'Ibaraki', 'country': 'Japan'}, {'city': 'Namegata-shi', 'state': 'Ibaraki', 'country': 'Japan'}, {'city': 'Tsuchiura-shi', 'state': 'Ibaraki', 'country': 'Japan'}, {'city': 'Yuuki-shi', 'state': 'Ibaraki', 'country': 'Japan'}, {'city': 'Hakusan-shi', 'state': 'Ishikawa-ken', 'country': 'Japan'}, {'city': 'Kanazawa', 'state': 'Ishikawa-ken', 'country': 'Japan', 'geoPoint': {'lat': 36.6, 'lon': 136.61667}}, {'city': 'Komatsu-shi', 'state': 'Ishikawa-ken', 'country': 'Japan'}, {'city': 'Takamatsu', 'state': 'Kagawa-ken', 'country': 'Japan', 'geoPoint': {'lat': 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