Ignite Creation Date:
2025-12-24 @ 2:48 PM
Ignite Modification Date:
2026-03-05 @ 12:30 AM
Study NCT ID:
NCT03050359
Status:
COMPLETED
Last Update Posted:
2020-06-12
First Post:
2017-02-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of TAK-438 (Vonoprazan) to Lansoprazole in the Treatment of Duodenal Ulcer Participants With or Without Helicobacter Pylori Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004381', 'term': 'Duodenal Ulcer'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}], 'ancestors': [{'id': 'D010437', 'term': 'Peptic Ulcer'}, {'id': 'D004378', 'term': 'Duodenal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C552956', 'term': '1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine'}, {'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': 'trialdisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Medical Director', 'organization': 'Takeda'}, 'certainAgreement': {'otherDetails': 'The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to Week 10 (Up to 6 weeks of treatment)', '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': 'TAK-438 20 mg', 'description': 'HP - participants: TAK-438 20 mg, tablets, orally, once daily (QD) and lansoprazole placebo-matching capsules, orally, QD for up to 6 weeks. HP + participants: TAK-438 20 mg, tablets, orally, twice daily (BID) and lansoprazole placebo-matching capsules, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed byTAK-438 20 mg, tablets, orally, QD and lansoprazole placebo-matching capsules, orally, QD for up to 4 weeks.', 'otherNumAtRisk': 263, 'deathsNumAtRisk': 263, 'otherNumAffected': 162, 'seriousNumAtRisk': 263, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Lansoprazole 30 mg', 'description': 'HP - participants: lansoprazole 30 mg, capsules, orally, QD and TAK-438 placebo-matching tablets, orally, QD for up to 6 weeks. HP + participants: lansoprazole 30 mg, capsules, orally, BID and TAK-438 placebo-matching tablets, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed by lansoprazole 30 mg, capsules, orally, QD and TAK-438 placebo-matching tablets, orally, BID for up to 4 weeks.', 'otherNumAtRisk': 268, 'deathsNumAtRisk': 268, 'otherNumAffected': 113, 'seriousNumAtRisk': 268, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 37}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA:22.0'}, {'term': 'Pepsinogen test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 124}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 28}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA:22.0'}, {'term': 'Pepsinogen I increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 92}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 37}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA:22.0'}, {'term': 'Blood gastrin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 97}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 20}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA:22.0'}, {'term': 'Protein urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA:22.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 17}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA:22.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 22}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA:22.0'}], 'seriousEvents': [{'term': 'Duodenal ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA:22.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA:22.0'}, {'term': 'Bladder transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA:22.0'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA:22.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Endoscopically Confirmed Healing of Duodenal Ulcers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-438 20 mg', 'description': 'HP - participants: TAK-438 20 mg, tablets, orally, once daily (QD) and lansoprazole placebo-matching capsules, orally, QD for up to 6 weeks. HP + participants: TAK-438 20 mg, tablets, orally, twice daily (BID) and lansoprazole placebo-matching capsules, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed byTAK-438 20 mg, tablets, orally, QD and lansoprazole placebo-matching capsules, orally, QD for up to 4 weeks.'}, {'id': 'OG001', 'title': 'Lansoprazole 30 mg', 'description': 'HP - participants: lansoprazole 30 mg, capsules, orally, QD and TAK-438 placebo-matching tablets, orally, QD for up to 6 weeks. HP + participants: lansoprazole 30 mg, capsules, orally, BID and TAK-438 placebo-matching tablets, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed by lansoprazole 30 mg, capsules, orally, QD and TAK-438 placebo-matching tablets, orally, BID for up to 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '96.9', 'groupId': 'OG000', 'lowerLimit': '93.889', 'upperLimit': '98.631'}, {'value': '96.5', 'groupId': 'OG001', 'lowerLimit': '93.406', 'upperLimit': '98.374'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Exact (Clopper-Pearson)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-2.998', 'ciUpperLimit': '3.791', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'If the lower bound of the 95% CI was ≥-6%, the DU healing rate for TAK-438 was considered to be noninferior to that seen with lansoprazole.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4 or Week 6', 'description': 'Endoscopic healing was defined as the disappearance of all white coats associated with duodenal ulcers as confirmed endoscopically.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included all participants who were randomized and received at least 1 dose of the study drug. Overall number of participants analyzed were participants with data available for analyses.'}, {'type': 'SECONDARY', 'title': 'Percentage of Helicobacter Pylori Infected (HP+) Participants With Successful HP Eradication After 4 or 6 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-438 20 mg', 'description': 'HP + participants: TAK-438 20 mg, tablets, orally, twice daily (BID) and lansoprazole placebo-matching capsules, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed byTAK-438 20 mg, tablets, orally, QD and lansoprazole placebo-matching capsules, orally, QD for up to 4 weeks.'}, {'id': 'OG001', 'title': 'Lansoprazole 30 mg', 'description': 'HP + participants: lansoprazole 30 mg, capsules, orally, BID and TAK-438 placebo-matching tablets, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed by lansoprazole 30 mg, capsules, orally, QD and TAK-438 placebo-matching tablets, orally, BID for up to 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '91.5', 'groupId': 'OG000', 'lowerLimit': '86.853', 'upperLimit': '94.866'}, {'value': '86.8', 'groupId': 'OG001', 'lowerLimit': '81.330', 'upperLimit': '91.093'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Exact (Clopper-Pearson)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.7', 'ciLowerLimit': '-1.281', 'ciUpperLimit': '10.690', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'If the lower bound of the 95% CI was ≥-10%, the HP eradication rate for TAK-438 was considered to be noninferior to that seen with lansoprazole.'}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks post treatment (Up to 10 weeks)', 'description': 'HP infection status was determined by \\^13C Urea Breath Test (\\^13C-UBT). The urea breath test is used to detect infection with HP, a bacteria associated with stomach ulcers, by testing individual breath samples in a central laboratory.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from FAS, included all participants who were randomized and received at least 1 dose of the study drug with H pylori positive status at Baseline with data available for analyses.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Endoscopically Confirmed Healing of Duodenal Ulcer at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-438 20 mg', 'description': 'HP - participants: TAK-438 20 mg, tablets, orally, once daily (QD) and lansoprazole placebo-matching capsules, orally, QD for up to 6 weeks. HP + participants: TAK-438 20 mg, tablets, orally, twice daily (BID) and lansoprazole placebo-matching capsules, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed byTAK-438 20 mg, tablets, orally, QD and lansoprazole placebo-matching capsules, orally, QD for up to 4 weeks.'}, {'id': 'OG001', 'title': 'Lansoprazole 30 mg', 'description': 'HP - participants: lansoprazole 30 mg, capsules, orally, QD and TAK-438 placebo-matching tablets, orally, QD for up to 6 weeks. HP + participants: lansoprazole 30 mg, capsules, orally, BID and TAK-438 placebo-matching tablets, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed by lansoprazole 30 mg, capsules, orally, QD and TAK-438 placebo-matching tablets, orally, BID for up to 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '89.2', 'groupId': 'OG000', 'lowerLimit': '84.617', 'upperLimit': '92.731'}, {'value': '88.4', 'groupId': 'OG001', 'lowerLimit': '83.830', 'upperLimit': '92.124'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Exact (Clopper-Pearson)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '-4.901', 'ciUpperLimit': '6.319', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'If the lower bound of the 95% CI was ≥-6%, the DU healing rate for TAK-438 was considered to be noninferior to that seen with lansoprazole.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4', 'description': 'Endoscopic healing is defined as the disappearance of all white coats associated with duodenal ulcers as confirmed endoscopically.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized and received at least 1 dose of the study drug. Overall number of participants analyzed were participants with data available for analyses.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Posttreatment Resolution of Gastrointestinal Symptoms Associated With Duodenal Ulcer at Weeks 2 Through 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-438 20 mg', 'description': 'HP - participants: TAK-438 20 mg, tablets, orally, once daily (QD) and lansoprazole placebo-matching capsules, orally, QD for up to 6 weeks. HP + participants: TAK-438 20 mg, tablets, orally, twice daily (BID) and lansoprazole placebo-matching capsules, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed byTAK-438 20 mg, tablets, orally, QD and lansoprazole placebo-matching capsules, orally, QD for up to 4 weeks.'}, {'id': 'OG001', 'title': 'Lansoprazole 30 mg', 'description': 'HP - participants: lansoprazole 30 mg, capsules, orally, QD and TAK-438 placebo-matching tablets, orally, QD for up to 6 weeks. HP + participants: lansoprazole 30 mg, capsules, orally, BID and TAK-438 placebo-matching tablets, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed by lansoprazole 30 mg, capsules, orally, QD and TAK-438 placebo-matching tablets, orally, BID for up to 4 weeks.'}], 'classes': [{'title': 'Epigastric Pain (Postprandial)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '87.7', 'groupId': 'OG000', 'lowerLimit': '76.321', 'upperLimit': '94.917'}, {'value': '91.8', 'groupId': 'OG001', 'lowerLimit': '80.399', 'upperLimit': '97.731'}]}]}, {'title': 'Epigastric Pain (Fasting/Nocturnal)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '91.7', 'groupId': 'OG000', 'lowerLimit': '85.579', 'upperLimit': '95.767'}, {'value': '90.1', 'groupId': 'OG001', 'lowerLimit': '83.902', 'upperLimit': '94.465'}]}]}, {'title': 'Abdominal Bloating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000', 'lowerLimit': '69.778', 'upperLimit': '92.519'}, {'value': '87.3', 'groupId': 'OG001', 'lowerLimit': '76.503', 'upperLimit': '94.355'}]}]}, {'title': 'Nausea/Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '85.2', 'groupId': 'OG000', 'lowerLimit': '66.269', 'upperLimit': '95.811'}, {'value': '94.4', 'groupId': 'OG001', 'lowerLimit': '72.706', 'upperLimit': '99.859'}]}]}, {'title': 'Heartburn', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '87.656', 'upperLimit': '100.000'}, {'value': '95.5', 'groupId': 'OG001', 'lowerLimit': '77.156', 'upperLimit': '99.885'}]}]}, {'title': 'Lack of Appetite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '90.9', 'groupId': 'OG000', 'lowerLimit': '70.839', 'upperLimit': '98.879'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '81.470', 'upperLimit': '100.000'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.1', 'ciLowerLimit': '-15.579', 'ciUpperLimit': '7.344', 'groupDescription': 'Epigastric Pain (Postprandial)', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.6', 'ciLowerLimit': '-5.230', 'ciUpperLimit': '8.422', 'groupDescription': 'Epigastric Pain (Fasting/Nocturnal)', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.0', 'ciLowerLimit': '-17.338', 'ciUpperLimit': '9.401', 'groupDescription': 'Abdominal Bloating', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.3', 'ciLowerLimit': '-26.334', 'ciUpperLimit': '7.815', 'groupDescription': 'Nausea/Vomiting', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.5', 'ciLowerLimit': '-4.159', 'ciUpperLimit': '13.250', 'groupDescription': 'Heartburn', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.1', 'ciLowerLimit': '-21.104', 'ciUpperLimit': '2.922', 'groupDescription': 'Lack of Appetite', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2 up to Week 6', 'description': 'The percentage of participants with resolution of various gastrointestinal symptoms are reported as categories. Gastrointestinal symptoms included epigastric pain (postprandial, fasting, nocturnal), abdominal bloating, nausea/vomiting, heartburn and lack of appetite. The severity of subjective symptoms of erosive esophagitis were recorded as: none = 0, mild = 1, moderate = 2 or severe = 3.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized and received at least 1 dose of the study drug. Number analyzed is number of participants analyzed for the particular category (symptom).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TAK-438 20 mg', 'description': 'H. pylori negative (HP -) participants: TAK-438 20 mg, tablets, orally, once daily (QD) and lansoprazole placebo-matching capsules, orally, QD for up to 6 weeks. H. pylori positive (HP +) participants: TAK-438 20 mg, tablets, orally, twice daily (BID) and lansoprazole placebo-matching capsules, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed byTAK-438 20 mg, tablets, orally, QD and lansoprazole placebo-matching capsules, orally, QD for up to 4 weeks.'}, {'id': 'FG001', 'title': 'Lansoprazole 30 mg', 'description': 'H. pylori negative (HP -) participants: lansoprazole 30 mg, capsules, orally, QD and TAK-438 placebo-matching tablets, orally, QD for up to 6 weeks. HP + participants: lansoprazole 30 mg, capsules, orally, BID and TAK-438 placebo-matching tablets, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed by lansoprazole 30 mg, capsules, orally, QD and TAK-438 placebo-matching tablets, orally, BID for up to 4 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '265'}, {'groupId': 'FG001', 'numSubjects': '268'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '248'}, {'groupId': 'FG001', 'numSubjects': '248'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '20'}]}], 'dropWithdraws': [{'type': 'Randomized But Not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Pretreatment Event/Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Significant Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Voluntary Withdrawal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Reason Not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 52 investigative sites in China, Korea, and Taiwan from 05 April 2017 to 19 July 2019.', 'preAssignmentDetails': 'Participants with or without diagnosis of Helicobacter pylori (H. Pylori) Infection were enrolled and randomly assigned in 1:1 ratio to receive either TAK-438 20 mg or lansoprazole 30 mg along with matching placebo (to keep the blind).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'BG000'}, {'value': '268', 'groupId': 'BG001'}, {'value': '533', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'TAK-438 20 mg', 'description': 'HP - participants: TAK-438 20 mg, tablets, orally, once daily (QD) and lansoprazole placebo-matching capsules, orally, QD for up to 6 weeks. HP + participants: TAK-438 20 mg, tablets, orally, twice daily (BID) and lansoprazole placebo-matching capsules, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed byTAK-438 20 mg, tablets, orally, QD and lansoprazole placebo-matching capsules, orally, QD for up to 4 weeks.'}, {'id': 'BG001', 'title': 'Lansoprazole 30 mg', 'description': 'HP - participants: lansoprazole 30 mg, capsules, orally, QD and TAK-438 placebo-matching tablets, orally, QD for up to 6 weeks. HP + participants: lansoprazole 30 mg, capsules, orally, BID and TAK-438 placebo-matching tablets, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed by lansoprazole 30 mg, capsules, orally, QD and TAK-438 placebo-matching tablets, orally, BID for up to 4 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'BG000'}, {'value': '268', 'groupId': 'BG001'}, {'value': '533', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '42.0', 'spread': '12.18', 'groupId': 'BG000'}, {'value': '41.4', 'spread': '12.89', 'groupId': 'BG001'}, {'value': '41.7', 'spread': '12.53', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'BG000'}, {'value': '268', 'groupId': 'BG001'}, {'value': '533', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '191', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '166', 'groupId': 'BG000'}, {'value': '176', 'groupId': 'BG001'}, {'value': '342', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'BG000'}, {'value': '268', 'groupId': 'BG001'}, {'value': '533', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '265', 'groupId': 'BG000'}, {'value': '268', 'groupId': 'BG001'}, {'value': '533', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'BG000'}, {'value': '268', 'groupId': 'BG001'}, {'value': '533', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '252', 'groupId': 'BG000'}, {'value': '255', 'groupId': 'BG001'}, {'value': '507', 'groupId': 'BG002'}]}]}, {'title': 'Korea, Republic Of', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'BG000'}, {'value': '268', 'groupId': 'BG001'}, {'value': '533', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'Taiwan, Province Of China', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'BG000'}, {'value': '268', 'groupId': 'BG001'}, {'value': '533', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'BG000'}, {'value': '268', 'groupId': 'BG001'}, {'value': '533', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '166.1', 'spread': '8.21', 'groupId': 'BG000'}, {'value': '167.1', 'spread': '8.09', 'groupId': 'BG001'}, {'value': '166.6', 'spread': '8.16', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeter (cm)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'BG000'}, {'value': '268', 'groupId': 'BG001'}, {'value': '531', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '63.45', 'spread': '12.342', 'groupId': 'BG000'}, {'value': '64.00', 'spread': '11.383', 'groupId': 'BG001'}, {'value': '63.72', 'spread': '11.860', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms (kg)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Number analyzed is the number of participants with data available for weight at Baseline.'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'BG000'}, {'value': '268', 'groupId': 'BG001'}, {'value': '531', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '22.87', 'spread': '3.365', 'groupId': 'BG000'}, {'value': '22.83', 'spread': '3.181', 'groupId': 'BG001'}, {'value': '22.85', 'spread': '3.270', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Body Mass Index=weight (kg)/\\[height (m)\\^2\\]', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Number analyzed is the number of participants with data available for BMI at Baseline.'}, {'title': 'Smoking Classification', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'BG000'}, {'value': '268', 'groupId': 'BG001'}, {'value': '533', 'groupId': 'BG002'}]}], 'categories': [{'title': 'The Participant Has Never Smoked', 'measurements': [{'value': '164', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '329', 'groupId': 'BG002'}]}, {'title': 'The Participant Is a Current Smoker', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '170', 'groupId': 'BG002'}]}, {'title': 'The Participant Is an Ex-smoker', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Consumption of Alcohol', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'BG000'}, {'value': '268', 'groupId': 'BG001'}, {'value': '533', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Drink Everyday', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Drink a Couple of Days Per Week', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Drink a Couple of Days Per Month', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}, {'title': 'Never Drink', 'measurements': [{'value': '191', 'groupId': 'BG000'}, {'value': '187', 'groupId': 'BG001'}, {'value': '378', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Consumption of Caffeine', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'BG000'}, {'value': '268', 'groupId': 'BG001'}, {'value': '533', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes (More Than 5 Times Per Week)', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'No (Never Drink or Less Than 5 Times Per Week)', 'measurements': [{'value': '242', 'groupId': 'BG000'}, {'value': '252', 'groupId': 'BG001'}, {'value': '494', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'History of H.pylori Eradication Therapy', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'BG000'}, {'value': '268', 'groupId': 'BG001'}, {'value': '533', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes (Therapy Received Ever)', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'No (Never Receive Any Therapy)', 'measurements': [{'value': '249', 'groupId': 'BG000'}, {'value': '263', 'groupId': 'BG001'}, {'value': '512', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'H. pylori Infection Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'BG000'}, {'value': '267', 'groupId': 'BG001'}, {'value': '530', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Positive', 'measurements': [{'value': '226', 'groupId': 'BG000'}, {'value': '229', 'groupId': 'BG001'}, {'value': '455', 'groupId': 'BG002'}]}, {'title': 'Negative', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants were evaluated for the H.pylori infection by result of 13C Urea Breath Test. Participants with infection were categorized as positive. Participants without infection were categorized as negative.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Number analyzed is the number of participants with data available for H. pylori Infection status at Baseline.'}, {'title': 'Characteristics of Current Duodenal Ulcers (DU): Location', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'BG000'}, {'value': '267', 'groupId': 'BG001'}, {'value': '532', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Superior Part (Including Bulb)', 'measurements': [{'value': '262', 'groupId': 'BG000'}, {'value': '266', 'groupId': 'BG001'}, {'value': '528', 'groupId': 'BG002'}]}, {'title': 'Descending Part', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants were categorized based on their location of ulcer.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Number analyzed is the number of participants with data available for location of ulcer at Baseline.'}, {'title': 'Characteristics of Current DU: Mean Number of Ulcers Found', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'BG000'}, {'value': '268', 'groupId': 'BG001'}, {'value': '531', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '0.48', 'groupId': 'BG000'}, {'value': '1.3', 'spread': '0.54', 'groupId': 'BG001'}, {'value': '1.2', 'spread': '0.51', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'number of ulcers', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Number analyzed is the number of participants with data available for number of ulcers found at Baseline.'}, {'title': 'Characteristics of Current DU: Ulcer Morphology', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'BG000'}, {'value': '268', 'groupId': 'BG001'}, {'value': '533', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Circular', 'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '227', 'groupId': 'BG002'}]}, {'title': 'Ellipsoidal', 'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '216', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants were categorized based on the morphology (shape) of ulcer: circular, ellipsoidal or other.', 'unitOfMeasure': 'Participants'}, {'title': 'Characteristics of Current DU: Ulcer Size', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'BG000'}, {'value': '268', 'groupId': 'BG001'}, {'value': '533', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Minuscule (<5 mm)', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Minor (>=5 mm/<10 mm)', 'measurements': [{'value': '183', 'groupId': 'BG000'}, {'value': '188', 'groupId': 'BG001'}, {'value': '371', 'groupId': 'BG002'}]}, {'title': 'Intermediate (>=10 mm/<=20 mm)', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}]}, {'title': 'Large (>20 mm/<30 mm)', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Giant (>=30 mm)', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants were categorized based on the size of ulcer: minuscule (\\<5 mm), minor (\\>=5 mm/\\<10 mm), intermediate (\\>=10 mm/\\<=20 mm), large (\\>20 mm/\\<30 mm), giant (\\>=30 mm).', 'unitOfMeasure': 'Participants'}, {'title': 'History of DU: Time Since Onset of Current Ulcers', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'BG000'}, {'value': '268', 'groupId': 'BG001'}, {'value': '533', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'BG000', 'lowerLimit': '1.0', 'upperLimit': '2.0'}, {'value': '1.0', 'groupId': 'BG001', 'lowerLimit': '1.0', 'upperLimit': '3.0'}, {'value': '1.0', 'groupId': 'BG002', 'lowerLimit': '1.0', 'upperLimit': '3.0'}]}]}], 'paramType': 'MEDIAN', 'description': 'Time since onset of current ulcers is defined as time in days from enrolment up to the onset of current ulcer.', 'unitOfMeasure': 'days', 'dispersionType': 'FULL_RANGE'}, {'title': 'Use of NSAIDs or Low-dose Aspirin at the Time of Ulcer Onset', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'BG000'}, {'value': '268', 'groupId': 'BG001'}, {'value': '533', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '264', 'groupId': 'BG000'}, {'value': '266', 'groupId': 'BG001'}, {'value': '530', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Participants who used the nonsteroidal anti-inflammatory drug (NSAID) were categorized as 'YES'. Participants who did not use the NSAID were categorized as 'NO'.", 'unitOfMeasure': 'Participants'}, {'title': 'History of DU: Type of Ulcers', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'BG000'}, {'value': '268', 'groupId': 'BG001'}, {'value': '533', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Primary', 'measurements': [{'value': '230', 'groupId': 'BG000'}, {'value': '227', 'groupId': 'BG001'}, {'value': '457', 'groupId': 'BG002'}]}, {'title': 'Recurrent', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants were categorized based on the the type of ulcers: primary or recurrent', 'unitOfMeasure': 'Participants'}, {'title': 'Time Since Onset of Recurrent Ulcers', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'BG000'}, {'value': '268', 'groupId': 'BG001'}, {'value': '533', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1149.3', 'spread': '910.72', 'groupId': 'BG000'}, {'value': '999.7', 'spread': '828.57', 'groupId': 'BG001'}, {'value': '1068.7', 'spread': '859.12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Time since onset of recurrent ulcers is defined as time in days from enrolment up to the onset of previous ulcer.', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-30', 'size': 1773413, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-05-27T13:57', 'hasProtocol': True}, {'date': '2019-07-23', 'size': 2181537, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-05-27T13:57', 'hasProtocol': False}]}}, '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': 533}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-07-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-27', 'studyFirstSubmitDate': '2017-02-08', 'resultsFirstSubmitDate': '2020-05-27', 'studyFirstSubmitQcDate': '2017-02-08', 'lastUpdatePostDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-27', 'studyFirstPostDateStruct': {'date': '2017-02-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Endoscopically Confirmed Healing of Duodenal Ulcers', 'timeFrame': 'Week 4 or Week 6', 'description': 'Endoscopic healing was defined as the disappearance of all white coats associated with duodenal ulcers as confirmed endoscopically.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Helicobacter Pylori Infected (HP+) Participants With Successful HP Eradication After 4 or 6 Weeks of Treatment', 'timeFrame': '4 weeks post treatment (Up to 10 weeks)', 'description': 'HP infection status was determined by \\^13C Urea Breath Test (\\^13C-UBT). The urea breath test is used to detect infection with HP, a bacteria associated with stomach ulcers, by testing individual breath samples in a central laboratory.'}, {'measure': 'Percentage of Participants With Endoscopically Confirmed Healing of Duodenal Ulcer at Week 4', 'timeFrame': 'Week 4', 'description': 'Endoscopic healing is defined as the disappearance of all white coats associated with duodenal ulcers as confirmed endoscopically.'}, {'measure': 'Percentage of Participants With Posttreatment Resolution of Gastrointestinal Symptoms Associated With Duodenal Ulcer at Weeks 2 Through 6', 'timeFrame': 'Week 2 up to Week 6', 'description': 'The percentage of participants with resolution of various gastrointestinal symptoms are reported as categories. Gastrointestinal symptoms included epigastric pain (postprandial, fasting, nocturnal), abdominal bloating, nausea/vomiting, heartburn and lack of appetite. The severity of subjective symptoms of erosive esophagitis were recorded as: none = 0, mild = 1, moderate = 2 or severe = 3.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug therapy', 'Gastrointestinal Diseases', 'Digestive System Diseases', 'Lansoprazole', 'Anti-Ulcer Agents', 'Gastrointestinal Agents', 'Proton Pump Inhibitors', 'Enzyme Inhibitors', 'Molecular Mechanisms of Pharmacological Action'], 'conditions': ['Duodenal Ulcer']}, 'referencesModule': {'references': [{'pmid': '39085080', 'type': 'DERIVED', 'citation': 'Hou X, Wang J, Du Q, Tian D, Hu N, Liu D, Zhou F, Xie L, Gu L, Kudou K, Zhang S. Efficacy and Safety of Vonoprazan-Based Quadruple Therapy for the Eradication of Helicobacter pylori in Patients with Peptic Ulcers: A Pooled Analysis of Two Randomized, Double-Blind, Double-Dummy, Phase 3 Trials. Biol Pharm Bull. 2024;47(8):1405-1414. doi: 10.1248/bpb.b24-00011.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate the non-inferior efficacy of TAK-438 versus lansoprazole in the treatment of participants with duodenal ulcer.', 'detailedDescription': 'The drug being tested in this study is called TAK-438. TAK-438 is being tested to treat people who have duodenal ulcers and also may or may not have Helicobacter pylori (HP) infection. This study will look at duodenal ulcer healing and also the elimination of HP in people who take TAK-438 versus lansoprazole. The study will enroll approximately 530 patients.\n\nParticipants were randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which remained undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):\n\n* TAK-438 20 mg\n* Lansoprazole 30 mg\n\nHP+ participants will be asked to take a TAK- 438 tablet and a lansoprazole capsule twice daily in conjunction with bismuth-containing quadruple therapy for 2 weeks, followed up by a TAK-438 tablet and a lansoprazole capsule once daily for up to 4 weeks. HP negative (HP-) participants will be asked to take a TAK-438 tablet and a lansoprazole capsule once daily for up to 6 weeks.\n\nThis multi-center trial will be conducted China, Korea and Taiwan. The overall time to participate in this study is up to 10 weeks. Participants will make multiple visits plus final visit at 2 weeks or 4 weeks after last dose of study drug for a follow-up assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Has endoscopic evidence of active duodenal ulcer(s) (i.e., mucosal defects with white coating \\[including cases associated with blood coagulation as long as there is no active bleeding\\]) measuring 5 mm or larger in longest diameter within 14 days prior to randomization.\n\nExclusion Criteria:\n\n1. Has received TAK-438 in a previous clinical study or as a therapeutic agent.\n2. Has a history or clinical manifestations of significant central nervous system (CNS), cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, endocrine or hematological disease that, in the opinion of the investigator, would confound the study results or compromise participant safety.\n3. Has been treated with Helicobacter pylori eradication therapy within 30 days prior to study treatment.\n4. Has a diagnosis of duodenal malignancy or a duodenal ulcer whose morphology suggested malignancy as evident by endoscopy within 14 days prior to randomization.\n5. Is suspected of having acute gastro-duodenal mucosal lesions (AGDML) as evident by endoscopy within 14 days prior to randomization.\n6. Has a linear ulcer (including a linear ulcer scar) that has been confirmed as evident by endoscopy within 14 days prior to randomization.\n7. Has active postoperative (eg, endoscopic mucosal resection / endoscopic submucosal dissection) ulcer(s) as confirmed by endoscopy within 14 days prior to randomization.\n8. Has gastric ulcer that has been confirmed by endoscopy within 14 days prior to randomization.\n9. Has ulcers for which medical therapy alone is not indicated (eg, perforation, pyloric stenosis, duodenal stenosis, major bleeding).\n10. Has undergone therapeutic upper gastrointestinal (GI) endoscopic therapy (eg, endoscopic hemostasis or excision including biopsy) within 30 days prior to visit 1.\n11. Has Zollinger-Ellison syndrome or gastric acid hypersecretion or those with a history of gastric acid hypersecretion.\n12. Has undergone major surgical procedures within 30 days prior to Visit 1 or are scheduled to undergo surgical procedures that may affect gastric acid secretion (eg, abdominal surgery, vagotomy or craniotomy).\n13. Has a history of malignancy or was treated for malignancy within 5 years before the start of the visit 1 (the participant may be included in the study if he/she has cured cutaneous basal cell carcinoma or cervical carcinoma in situ).\n14. Has a known acquired immunodeficiency syndrome (AIDS) or hepatitis infection, including hepatitis virus carriers (hepatitis B surface-antigen \\[HBsAg\\] - or hepatitis C virus (HCV)-antibody-positive) (the participant may be included in the study if he/she is HCV-viral load-RNA-negative).\n15. Laboratory tests performed prior to randomization revealed any of the following abnormalities in the participant:\n\n 1. Creatinine levels: \\>2 mg/dL (\\>177 μmol/L).\n 2. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST), or total bilirubin levels: \\> upper limit of normal (ULN).\n16. Has hypersensitivity to TAK-438, proton pump inhibitors (PPIs), bismuth, clarithromycin, or amoxicillin. Skin testing may be performed according to local standard practice (for HP+ participants only).'}, 'identificationModule': {'nctId': 'NCT03050359', 'briefTitle': 'Comparison of TAK-438 (Vonoprazan) to Lansoprazole in the Treatment of Duodenal Ulcer Participants With or Without Helicobacter Pylori Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Randomized Double-Blind, Double-Dummy, Phase 3 Study to Evaluate the Efficacy and Safety of Oral TAK-438 20 mg Compared to Lansoprazole 30 mg Once- or Twice-Daily in the Treatment of Endoscopically Confirmed Duodenal Ulcer Subjects With or Without Helicobacter Pylori Infection', 'orgStudyIdInfo': {'id': 'TAK-438_304'}, 'secondaryIdInfos': [{'id': 'U1111-1139-0293', 'type': 'REGISTRY', 'domain': 'WHO'}, {'id': 'CTR20170104', 'type': 'REGISTRY', 'domain': 'CFDA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TAK-438 20 mg', 'description': 'H. pylori negative (HP -) participants: TAK-438 20 mg, tablets, orally, once daily (QD) and lansoprazole placebo-matching capsules, orally, QD for up to 6 weeks. H. pylori positive (HP +) participants: TAK-438 20 mg, tablets, orally, twice daily (BID) and lansoprazole placebo-matching capsules, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed byTAK-438 20 mg, tablets, orally, QD and lansoprazole placebo-matching capsules, orally, QD for up to 4 weeks.', 'interventionNames': ['Drug: TAK-438', 'Drug: Lansoprazole Placebo', 'Drug: Bismuth-Containing Quadruple Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Lansoprazole 30 mg', 'description': 'H. pylori negative (HP -) participants: lansoprazole 30 mg, capsules, orally, QD and TAK-438 placebo-matching tablets, orally, QD for up to 6 weeks. HP + participants: lansoprazole 30 mg, capsules, orally, BID and TAK-438 placebo-matching tablets, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed by lansoprazole 30 mg, capsules, orally, QD and TAK-438 placebo-matching tablets, orally, BID for up to 4 weeks.', 'interventionNames': ['Drug: Lansoprazole', 'Drug: TAK-438 Placebo', 'Drug: Bismuth-Containing Quadruple Therapy']}], 'interventions': [{'name': 'TAK-438', 'type': 'DRUG', 'otherNames': ['Vonoprazan'], 'description': 'TAK-438 tablets', 'armGroupLabels': ['TAK-438 20 mg']}, {'name': 'Lansoprazole', 'type': 'DRUG', 'otherNames': ['Prevacid'], 'description': 'Lansoprazole capsules', 'armGroupLabels': ['Lansoprazole 30 mg']}, {'name': 'TAK-438 Placebo', 'type': 'DRUG', 'description': 'TAK-438 placebo-matching tablets.', 'armGroupLabels': ['Lansoprazole 30 mg']}, {'name': 'Lansoprazole Placebo', 'type': 'DRUG', 'description': 'Lansoprazole placebo-matching capsules', 'armGroupLabels': ['TAK-438 20 mg']}, {'name': 'Bismuth-Containing Quadruple Therapy', 'type': 'DRUG', 'description': '1 g Amoxicillin, 500 mg clarithromycin and 600 mg bismuth potassium citrate/bismuth tripotassium dicitrate, twice daily (BID).', 'armGroupLabels': ['Lansoprazole 30 mg', 'TAK-438 20 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '230024', 'city': 'Hefei', 'state': 'Anhui', 'country': 'China', 'facility': 'The First Affiliated Hospital of Anhui Medical University', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '241001', 'city': 'Wuhu', 'state': 'Anhui', 'country': 'China', 'facility': 'Yijishan hospital of Wan nan Medical college', 'geoPoint': {'lat': 31.35259, 'lon': 118.42947}}, {'zip': '100020', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Chao Yang Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100039', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': "The General 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{'zip': '6000', 'city': 'Cebu City', 'country': 'Philippines', 'facility': 'Cebu Doctors University Hospital', 'geoPoint': {'lat': 10.31672, 'lon': 123.89071}}, {'zip': '1634', 'city': 'City of Taguig', 'country': 'Philippines', 'facility': "St. Luke's Medical Center Global City", 'geoPoint': {'lat': 14.5243, 'lon': 121.0792}}, {'zip': '4114', 'city': 'Dasmarinas City, Cavite', 'country': 'Philippines', 'facility': 'De La Salle University Medical Center'}, {'zip': '8000', 'city': 'Davao City', 'country': 'Philippines', 'facility': 'Davao Doctors Hospital', 'geoPoint': {'lat': 7.07306, 'lon': 125.61278}}, {'zip': '5000', 'city': 'Iloilo City', 'country': 'Philippines', 'facility': 'West Visayas State University Medical Center', 'geoPoint': {'lat': 10.69694, 'lon': 122.56444}}, {'zip': '1000', 'city': 'Manila', 'country': 'Philippines', 'facility': 'Philippine General Hospital', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'zip': '26426', 'city': 'Wŏnju', 'state': 'Gangwon-do', 'country': 'South Korea', 'facility': 'Yonsei University Wonju Severance Christian Hospital', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}, {'zip': '15355', 'city': 'Ansan-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Korea University Ansan Hospital', 'geoPoint': {'lat': 37.32361, 'lon': 126.82194}}, {'zip': '14647', 'city': 'Bucheon-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'The Catholic University of Korea, Bucheon St. Mary s Hospital', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'zip': '11923', 'city': 'Guri-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Hanyang Univerisy Guri Hospital', 'geoPoint': {'lat': 37.5986, 'lon': 127.1394}}, {'zip': '13620', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'zip': '16247', 'city': 'Suwon', 'state': 'Gyeonggi-do', 'country': 'South 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Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '100', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '11217', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Veterans General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '11490', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Tri-Service General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '333', 'city': 'Taoyuan', 'country': 'Taiwan', 'facility': 'Chang Gung Memorial Hospital, Linkou', 'geoPoint': {'lat': 24.99368, 'lon': 121.29696}}], 'overallOfficials': [{'name': 'Medical Director Clinical Science', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}