Ignite Creation Date:
2025-12-25 @ 1:13 AM
Ignite Modification Date:
2025-12-25 @ 11:23 PM
Study NCT ID:
NCT00251693
Status:
COMPLETED
Last Update Posted:
2012-02-03
First Post:
2005-11-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004942', 'term': 'Esophagitis, Peptic'}], 'ancestors': [{'id': 'D004941', 'term': 'Esophagitis'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D010437', 'term': 'Peptic Ulcer'}, {'id': 'D004378', 'term': 'Duodenal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064748', 'term': 'Dexlansoprazole'}, {'id': 'D064747', 'term': 'Lansoprazole'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrialregistry@tpna.com', 'phone': '800-778-2860', 'title': 'Sr. VP Clinical Sciences', 'organization': 'Takeda Global Research and Development Center, Inc.'}, 'certainAgreement': {'otherDetails': 'No publication related to study results will be published prior to publication of a multi-center report submitted for publication within 18 months after conclusion or termination of a study. Results publications will be submitted to sponsor for review 60 days in advance of publication. Sponsor can require removal of confidential information unrelated to study results. Sponsor can embargo a proposed publication for another 60 days to preserve intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Dexlansoprazole MR 60 mg QD', 'description': 'Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.', 'otherNumAtRisk': 680, 'otherNumAffected': 63, 'seriousNumAtRisk': 680, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Dexlansoprazole MR 90 mg QD', 'description': 'Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.', 'otherNumAtRisk': 668, 'otherNumAffected': 53, 'seriousNumAtRisk': 668, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Lansoprazole 30 mg QD', 'description': 'Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.', 'otherNumAtRisk': 690, 'otherNumAffected': 50, 'seriousNumAtRisk': 690, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Diarrhoea (Excl 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Coronary Artery Disorders not elsewhere classified (NEC)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 680, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 668, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 690, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Duodenal and Small Intestinal Stenosis and Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 680, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 668, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 690, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gastrointestinal (GI) Atonic and Hypomotility Disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 680, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 668, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 690, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastrointestinal Inflammatory Disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 680, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 668, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 690, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Haemorrhoids and GI Varices (Excluding [Excl] Oesophageal)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 680, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 668, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 690, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Intestinal Ulcers and Perforation NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 680, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 668, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 690, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Peritoneal and Retroperitoneal Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 680, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 668, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 690, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pain and Discomfort NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 680, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 668, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 690, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cholecystitis and Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 680, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 668, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 690, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Infections NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 680, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 668, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 690, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lower Respiratory Tract and Lung Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 680, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 668, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 690, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sepsis, Bacteraemia, Viraemia and Fungaemia NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 680, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 668, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 690, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Streptococcal Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 680, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 668, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 690, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Non-site Specfic Procedural Complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 680, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 668, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 690, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Potassium Imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 680, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 668, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 690, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Soft Tissue Disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 680, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 668, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 690, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute Polyneuropathies', 'stats': [{'groupId': 'EG000', 'numAtRisk': 680, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 668, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 690, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Transient Cerebrovascular (CV) Events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 680, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 668, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 690, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Paralysis and Paresis (Excl Cranial Nerve)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 680, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 668, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 690, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Central Nervous System Hemorrhages and CV accidents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 680, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 668, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 690, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bipolar Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 680, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 668, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 690, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory Failures (Excl Neonatal)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 680, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 668, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 690, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects With Complete Healing of Erosive Esophagitis (EE) by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '639', 'groupId': 'OG000'}, {'value': '634', 'groupId': 'OG001'}, {'value': '656', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexlansoprazole MR 60 mg QD', 'description': 'Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.'}, {'id': 'OG001', 'title': 'Dexlansoprazole MR 90 mg QD', 'description': 'Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.'}, {'id': 'OG002', 'title': 'Lansoprazole 30 mg QD', 'description': 'Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '85.3', 'groupId': 'OG000', 'lowerLimit': '82.3', 'upperLimit': '87.9'}, {'value': '85.8', 'groupId': 'OG001', 'lowerLimit': '82.8', 'upperLimit': '88.4'}, {'value': '79.0', 'groupId': 'OG002', 'lowerLimit': '75.6', 'upperLimit': '82.0'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in percentage', 'ciPctValue': '95', 'paramValue': '6.33', 'ciLowerLimit': '2.17', 'ciUpperLimit': '10.48', 'pValueComment': "Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.", 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'If the lower bound of the 95% CI was greater than -10%, noninferiority was concluded. Superiority of primary efficacy endpoint was assessed by comparing the crude healing rate of dexlansoprazole MR 60 mg dose to that of lansoprazole 30 mg using a Cochran Mantel Haenszel (CMH) test with baseline LA EE Grade as strata.'}, {'pValue': '0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in percentage', 'ciPctValue': '95', 'paramValue': '6.84', 'ciLowerLimit': '2.70', 'ciUpperLimit': '10.98', 'pValueComment': "Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.", 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'If the lower bound of the 95% CI was greater than -10%, noninferiority was concluded. Superiority of primary efficacy endpoint was assessed by comparing the crude healing rate of dexlansoprazole MR 90 mg dose to that of lansoprazole 30 mg using a Cochran Mantel Haenszel (CMH) test with baseline LA EE Grade as strata.'}, {'pValue': '0.727', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '8 Weeks', 'description': "Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A (greater than or equal to 1 mucosal break and less than 5 mm). If it doesn't meet the A criterion, it's counted as healed.", 'unitOfMeasure': 'Percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Crude rate analyses were performed on the ITT subjects who had at least 1 post-baseline endoscopy assessment performed within 7 days of the last day of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexlansoprazole MR 60 mg QD', 'description': 'Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.'}, {'id': 'OG001', 'title': 'Dexlansoprazole MR 90 mg QD', 'description': 'Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.'}, {'id': 'OG002', 'title': 'Lansoprazole 30 mg QD', 'description': 'Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '79.7', 'groupId': 'OG000', 'lowerLimit': '73.1', 'upperLimit': '85.3'}, {'value': '74.1', 'groupId': 'OG001', 'lowerLimit': '67.1', 'upperLimit': '80.2'}, {'value': '65.0', 'groupId': 'OG002', 'lowerLimit': '58.0', 'upperLimit': '71.6'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.045', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.245', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '8 Weeks', 'description': "Percentage of subjects with baseline EE grade C or D combined who have complete healing of erosive esophagitis as assessed by endoscopy for Change in LA Esophagitis Classification Grades C and D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.", 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Crude rate analyses were performed on the ITT subjects who had at least 1 post-baseline endoscopy assessment performed within 7 days of the last day of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}, {'value': '208', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexlansoprazole MR 60 mg QD', 'description': 'Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.'}, {'id': 'OG001', 'title': 'Dexlansoprazole MR 90 mg QD', 'description': 'Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.'}, {'id': 'OG002', 'title': 'Lansoprazole 30 mg QD', 'description': 'Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '88.9', 'groupId': 'OG000', 'lowerLimit': '83.7', 'upperLimit': '94.2'}, {'value': '83.8', 'groupId': 'OG001', 'lowerLimit': '77.4', 'upperLimit': '90.1'}, {'value': '74.5', 'groupId': 'OG002', 'lowerLimit': '67.3', 'upperLimit': '81.6'}]}]}], 'analyses': [{'pValue': '0.011', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.017', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.927', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '8 Weeks', 'description': "Percentage of subjects with baseline EE grade C or D combined who have complete healing of EE as assessed by endoscopy for Change in LA Esophagitis Classification Grades C and D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.", 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'In addition to the ITT subjects who had at least 1 post-baseline endoscopy, Life Table Method included the ITT subjects without any post-baseline endoscopy within 7 days of the last day of study drug as censored.'}, {'type': 'PRIMARY', 'title': 'Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '673', 'groupId': 'OG000'}, {'value': '665', 'groupId': 'OG001'}, {'value': '684', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexlansoprazole MR 60 mg QD', 'description': 'Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.'}, {'id': 'OG001', 'title': 'Dexlansoprazole MR 90 mg QD', 'description': 'Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.'}, {'id': 'OG002', 'title': 'Lansoprazole 30 mg QD', 'description': 'Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '92.3', 'groupId': 'OG000', 'lowerLimit': '90.0', 'upperLimit': '94.7'}, {'value': '92.2', 'groupId': 'OG001', 'lowerLimit': '89.8', 'upperLimit': '94.6'}, {'value': '86.1', 'groupId': 'OG002', 'lowerLimit': '83.0', 'upperLimit': '89.2'}]}]}], 'analyses': [{'pValue': '0.060', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in percentage', 'ciPctValue': '95', 'paramValue': '6.20', 'ciLowerLimit': '2.30', 'ciUpperLimit': '10.11', 'pValueComment': "Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.", 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was supported if the lower bound of the 95% CI for the difference with lansoprazole 30 mg of the estimated 8-week healing rate was greater than -10%. Superiority was assessed based on log-rank tests comparing treatments for the endpoints.'}, {'pValue': '0.029', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in percentage', 'ciPctValue': '95', 'paramValue': '6.08', 'ciLowerLimit': '2.16', 'ciUpperLimit': '10.00', 'pValueComment': "Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.", 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was supported if the lower bound of the 95% CI for the difference with lansoprazole 30 mg of the estimated 8-week healing rate was greater than -10%. Superiority was assessed based on log-rank tests comparing treatments for the endpoints.'}, {'pValue': '0.707', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': "Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.", 'unitOfMeasure': 'Percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'In addition to the ITT subjects who had at least 1 post-baseline endoscopy, Life Table Method included the ITT subjects without any post-baseline endoscopy within 7 days of the last day of study drug as censored.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Crude Rate Analyses.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '639', 'groupId': 'OG000'}, {'value': '634', 'groupId': 'OG001'}, {'value': '656', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexlansoprazole MR 60 mg QD', 'description': 'Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.'}, {'id': 'OG001', 'title': 'Dexlansoprazole MR 90 mg QD', 'description': 'Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.'}, {'id': 'OG002', 'title': 'Lansoprazole 30 mg QD', 'description': 'Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '66.2', 'groupId': 'OG000', 'lowerLimit': '62.4', 'upperLimit': '69.9'}, {'value': '68.8', 'groupId': 'OG001', 'lowerLimit': '65.0', 'upperLimit': '72.4'}, {'value': '64.8', 'groupId': 'OG002', 'lowerLimit': '61.0', 'upperLimit': '68.4'}]}]}], 'analyses': [{'pValue': '0.705', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.146', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.283', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '4 Weeks', 'description': "Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.", 'unitOfMeasure': 'Percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Crude rate analyses were performed on the ITT subjects who had at least 1 post-baseline endoscopy assessment performed within 7 days of the last day of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Life Table Method.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '673', 'groupId': 'OG000'}, {'value': '665', 'groupId': 'OG001'}, {'value': '684', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexlansoprazole MR 60 mg QD', 'description': 'Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.'}, {'id': 'OG001', 'title': 'Dexlansoprazole MR 90 mg QD', 'description': 'Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.'}, {'id': 'OG002', 'title': 'Lansoprazole 30 mg QD', 'description': 'Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '77.0', 'groupId': 'OG000', 'lowerLimit': '73.5', 'upperLimit': '80.5'}, {'value': '78.8', 'groupId': 'OG001', 'lowerLimit': '75.4', 'upperLimit': '82.2'}, {'value': '76.5', 'groupId': 'OG002', 'lowerLimit': '73.0', 'upperLimit': '80.0'}]}]}], 'analyses': [{'pValue': '0.896', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.241', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.211', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '4 Weeks', 'description': "Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.", 'unitOfMeasure': 'Percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'In addition to the ITT subjects who had at least 1 post-baseline endoscopy, Life Table Method included the ITT subjects without any post-baseline endoscopy within 7 days of the last day of study drug as censored.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dexlansoprazole MR 60 mg QD', 'description': 'Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.'}, {'id': 'FG001', 'title': 'Dexlansoprazole MR 90 mg QD', 'description': 'Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.'}, {'id': 'FG002', 'title': 'Lansoprazole 30 mg QD', 'description': 'Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '680'}, {'groupId': 'FG001', 'numSubjects': '668'}, {'groupId': 'FG002', 'numSubjects': '690'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '629'}, {'groupId': 'FG001', 'numSubjects': '624'}, {'groupId': 'FG002', 'numSubjects': '644'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '44'}, {'groupId': 'FG002', 'numSubjects': '46'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Inclusion/exclusion criteria not met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Noncompliant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': "Possible Barrett's esophagus", 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Subject request/subject unavailable', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Abnormal laboratory findings', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Subjects were enrolled at 95 sites in the United States (US) and 55 ex-US sites from 02 December 2005 to 30 January 2007.', 'preAssignmentDetails': 'Subjects recorded day and nighttime heartburn symptoms and rescue medications for a screening period of up to 21 days. Subjects with endoscopically-proven erosive esophagitis (EE) at screening were enrolled in Dexlansoprazole Modified Release (MR) or Lansoprazole once daily (QD) treatment group.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '680', 'groupId': 'BG000'}, {'value': '668', 'groupId': 'BG001'}, {'value': '690', 'groupId': 'BG002'}, {'value': '2038', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Dexlansoprazole MR 60 mg QD', 'description': 'Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.'}, {'id': 'BG001', 'title': 'Dexlansoprazole MR 90 mg QD', 'description': 'Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.'}, {'id': 'BG002', 'title': 'Lansoprazole 30 mg QD', 'description': 'Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<45 Years', 'categories': [{'measurements': [{'value': '269', 'groupId': 'BG000'}, {'value': '276', 'groupId': 'BG001'}, {'value': '288', 'groupId': 'BG002'}, {'value': '833', 'groupId': 'BG003'}]}]}, {'title': '45 Years to <65 Years', 'categories': [{'measurements': [{'value': '349', 'groupId': 'BG000'}, {'value': '328', 'groupId': 'BG001'}, {'value': '332', 'groupId': 'BG002'}, {'value': '1009', 'groupId': 'BG003'}]}]}, {'title': '>=65 Years', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}, {'value': '196', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.8', 'spread': '13.71', 'groupId': 'BG000'}, {'value': '47.3', 'spread': '13.93', 'groupId': 'BG001'}, {'value': '47.3', 'spread': '13.74', 'groupId': 'BG002'}, {'value': '47.5', 'spread': '13.79', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '300', 'groupId': 'BG000'}, {'value': '302', 'groupId': 'BG001'}, {'value': '325', 'groupId': 'BG002'}, {'value': '927', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '380', 'groupId': 'BG000'}, {'value': '366', 'groupId': 'BG001'}, {'value': '365', 'groupId': 'BG002'}, {'value': '1111', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '166', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '620', 'groupId': 'BG000'}, {'value': '616', 'groupId': 'BG001'}, {'value': '636', 'groupId': 'BG002'}, {'value': '1872', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '602', 'groupId': 'BG000'}, {'value': '580', 'groupId': 'BG001'}, {'value': '601', 'groupId': 'BG002'}, {'value': '1783', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Los Angeles (LA) Classification Grade for Erosive Esophagitis (EE)', 'classes': [{'title': 'A: ≥1 mucosal break <5mm', 'categories': [{'measurements': [{'value': '236', 'groupId': 'BG000'}, {'value': '242', 'groupId': 'BG001'}, {'value': '231', 'groupId': 'BG002'}, {'value': '709', 'groupId': 'BG003'}]}]}, {'title': 'B: ≥1 mucosal break ≥5mm', 'categories': [{'measurements': [{'value': '247', 'groupId': 'BG000'}, {'value': '233', 'groupId': 'BG001'}, {'value': '248', 'groupId': 'BG002'}, {'value': '728', 'groupId': 'BG003'}]}]}, {'title': 'C: ≥1 mucosal break and <75% of the circumference', 'categories': [{'measurements': [{'value': '163', 'groupId': 'BG000'}, {'value': '148', 'groupId': 'BG001'}, {'value': '170', 'groupId': 'BG002'}, {'value': '481', 'groupId': 'BG003'}]}]}, {'title': 'D: ≥1 mucosal break and ≥75% of the circumference', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '118', 'groupId': 'BG003'}]}]}, {'title': 'Not Applicable', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'LA Classification for Esophagitis Grading System (grades A, B, C, D) with increasing severity from grade A to grade D.', 'unitOfMeasure': 'Paricipants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2038}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-01', 'studyFirstSubmitDate': '2005-11-08', 'resultsFirstSubmitDate': '2009-02-20', 'studyFirstSubmitQcDate': '2005-11-08', 'lastUpdatePostDateStruct': {'date': '2012-02-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-03-20', 'studyFirstPostDateStruct': {'date': '2005-11-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-03-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects With Complete Healing of Erosive Esophagitis (EE) by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.', 'timeFrame': '8 Weeks', 'description': "Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A (greater than or equal to 1 mucosal break and less than 5 mm). If it doesn't meet the A criterion, it's counted as healed."}, {'measure': 'Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method.', 'timeFrame': '8 weeks', 'description': "Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed."}], 'secondaryOutcomes': [{'measure': 'Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.', 'timeFrame': '8 Weeks', 'description': "Percentage of subjects with baseline EE grade C or D combined who have complete healing of erosive esophagitis as assessed by endoscopy for Change in LA Esophagitis Classification Grades C and D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed."}, {'measure': 'Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method.', 'timeFrame': '8 Weeks', 'description': "Percentage of subjects with baseline EE grade C or D combined who have complete healing of EE as assessed by endoscopy for Change in LA Esophagitis Classification Grades C and D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed."}, {'measure': 'Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Crude Rate Analyses.', 'timeFrame': '4 Weeks', 'description': "Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed."}, {'measure': 'Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Life Table Method.', 'timeFrame': '4 Weeks', 'description': "Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Erosive Esophagitis'], 'conditions': ['Esophagitis, Reflux', 'Esophagitis, Peptic']}, 'referencesModule': {'references': [{'pmid': '19183157', 'type': 'RESULT', 'citation': 'Sharma P, Shaheen NJ, Perez MC, Pilmer BL, Lee M, Atkinson SN, Peura D. Clinical trials: healing of erosive oesophagitis with dexlansoprazole MR, a proton pump inhibitor with a novel dual delayed-release formulation--results from two randomized controlled studies. Aliment Pharmacol Ther. 2009 Apr 1;29(7):731-41. doi: 10.1111/j.1365-2036.2009.03933.x.'}, {'pmid': '19735233', 'type': 'RESULT', 'citation': 'Peura DA, Metz DC, Dabholkar AH, Paris MM, Yu P, Atkinson SN. Safety profile of dexlansoprazole MR, a proton pump inhibitor with a novel dual delayed release formulation: global clinical trial experience. Aliment Pharmacol Ther. 2009 Nov 15;30(10):1010-21. doi: 10.1111/j.1365-2036.2009.04137.x. Epub 2009 Sep 4.'}, {'pmid': '20195905', 'type': 'RESULT', 'citation': 'Wyrwich KW, Mody R, Larsen LM, Lee M, Harnam N, Revicki DA. Validation of the PAGI-SYM and PAGI-QOL among healing and maintenance of erosive esophagitis clinical trial participants. Qual Life Res. 2010 May;19(4):551-64. doi: 10.1007/s11136-010-9620-x. Epub 2010 Feb 27.'}, {'pmid': '21129076', 'type': 'RESULT', 'citation': 'Friedlander EA, Pallentino J, Miller SK, VanBeuge SS. The evolution of proton pump inhibitors for the treatment of gastroesophageal reflux disease. J Am Acad Nurse Pract. 2010 Dec;22(12):674-83. doi: 10.1111/j.1745-7599.2010.00578.x. Epub 2010 Nov 24.'}, {'pmid': '24118079', 'type': 'DERIVED', 'citation': 'Peura DA, Pilmer B, Hunt B, Mody R, Perez MC. Distinguishing the impact of dexlansoprazole on heartburn vs. regurgitation in patients with gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 2013 Nov;38(10):1303-11. doi: 10.1111/apt.12504. Epub 2013 Sep 30.'}, {'pmid': '23451835', 'type': 'DERIVED', 'citation': 'Peura DA, Pilmer B, Hunt B, Mody R, Perez MC. The effects of increasing body mass index on heartburn severity, frequency and response to treatment with dexlansoprazole or lansoprazole. Aliment Pharmacol Ther. 2013 Apr;37(8):810-8. doi: 10.1111/apt.12270. Epub 2013 Mar 4.'}], 'seeAlsoLinks': [{'url': 'http://general.takedapharm.com/content/file/pi.pdf?applicationcode=9efb34b3-fb69-4190-a2be-a90b8cb94e25&filetypecode=DEXILANTPI', 'label': 'For the Dexilant Package Insert refer to this link'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy and safety of 8 weeks of once-daily (QD) treatment with dexlansoprazole modified release (MR) 60 mg or 90 mg or lansoprazole 30 mg in healing subjects with endoscopically proven erosive esophagitis.', 'detailedDescription': 'This is a Phase 3, randomized, double-blind, multi-center, active-controlled, 3-arm study with an 8-week treatment period. This study will compare the efficacy of dexlansoprazole MR (60 mg QD and 90 mg QD) with that of lansoprazole (30 mg) when administered orally as a single daily dose in the morning, before breakfast. The study is designed to evaluate healing of erosive esophagitis and the effect of the therapy on relieving gastroesophageal reflux disease-related symptoms. The study consists of two periods, a screening period (maximum 21 days) and a treatment period, which will last 8 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject must have endoscopically confirmed erosive esophagitis as defined by the Los Angeles (LA) Classification Grading System (A-D)\n\nExclusion Criteria:\n\n* Subject has a positive Campylobacter-like organisms (CLO) test for Helicobacter (H.) pylori.\n* Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists or sucralfate, drugs with significant anticholinergic effects, misoprostol or prokinetics\n* Use of antacids \\[except for study supplied Gelusil®\\]\n* Need for continuous anticoagulant therapy (blood thinners)\n* Endoscopic Barrett's esophagus and/or definite dysplastic changes in the esophagus\n* History of dilatation of esophageal strictures, other than Schatzki's ring (a ring of mucosal tissue near the lower esophageal sphincter)\n* Current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition.\n* History of gastric, duodenal or esophageal surgery except simple oversew of an ulcer.\n* Acute upper gastrointestinal hemorrhage within 4 weeks of the screening endoscopy"}, 'identificationModule': {'nctId': 'NCT00251693', 'briefTitle': 'Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Phase 3 Study to Evaluate the Efficacy and Safety of TAK-390MR (60 mg Once- Daily [QD] and 90 mg QD) and an Active Comparator, Lansoprazole (30 mg QD) on Healing of Erosive Esophagitis', 'orgStudyIdInfo': {'id': 'T-EE04-084'}, 'secondaryIdInfos': [{'id': 'U1111-1113-9373', 'type': 'REGISTRY', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 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