Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2025-12-28 @ 11:05 AM
Study NCT ID:
NCT01452750
Status:
COMPLETED
Last Update Posted:
2014-02-05
First Post:
2011-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Non-steroidal Anti-inflammatory Drug (NSAID)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013276', 'term': 'Stomach Ulcer'}, {'id': 'D004381', 'term': 'Duodenal Ulcer'}], 'ancestors': [{'id': 'D010437', 'term': 'Peptic Ulcer'}, {'id': 'D004378', 'term': 'Duodenal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 642}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-04', 'studyFirstSubmitDate': '2011-09-16', 'studyFirstSubmitQcDate': '2011-10-14', 'lastUpdatePostDateStruct': {'date': '2014-02-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence rate of gastric or duodenal ulcer within 24 weeks', 'timeFrame': '24 weeks', 'description': 'Mucosal defects with a white coating of 3 mm or larger will be determined as ulcers. Recurrence rate of gastric or duodenal ulcer within 24 weeks will be calculated for each treatment group.'}], 'secondaryOutcomes': [{'measure': 'Recurrence rate of gastric or duodenal ulcer within 12 weeks', 'timeFrame': '12 weeks'}, {'measure': 'Gastric mucosal injury', 'timeFrame': '24 Weeks'}, {'measure': 'Duodenal mucosal injury', 'timeFrame': '24 weeks'}, {'measure': 'Occurrence rate of hemorrhagic lesion in stomach or duodenum', 'timeFrame': '24 weeks'}, {'measure': 'Time to recurrence of gastric or duodenal ulcer', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Drug Therapy'], 'conditions': ['Gastric Ulcers', 'Duodenal Ulcers']}, 'referencesModule': {'references': [{'pmid': '28988197', 'type': 'DERIVED', 'citation': 'Mizokami Y, Oda K, Funao N, Nishimura A, Soen S, Kawai T, Ashida K, Sugano K. Vonoprazan prevents ulcer recurrence during long-term NSAID therapy: randomised, lansoprazole-controlled non-inferiority and single-blind extension study. Gut. 2018 Jun;67(6):1042-1051. doi: 10.1136/gutjnl-2017-314010. Epub 2017 Oct 7.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of TAK-438, once daily (QD), compared to AG-1749 (Lansoprazole) in patients with a history of gastric or duodenal ulcer who require long-term therapy of non-steroidal anti-Inflammatory drug (NSAID).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participants who require continuous NSAID therapy during the treatment period with the study drug\n2. Participants who have a history of ulcer in stomach or duodenum, endoscopically confirmed\n3. Outpatient (including inpatient for examinations)\n\nExclusion Criteria:\n\n1. Participants scheduled to change the type and dosage regimen of NSAID\n2. Participants with ulcers or bleeding in stomach or duodenum, endoscopically confirmed\n3. Participants with small intestine bleeding, large intestine bleeding, or gastrointestinal bleeding of unknown etiology\n4. Participants who have a history of surgery which affects gastric acid secretion (e.g., resection of upper gastrointestinal tract, vagotomy) or who are scheduled to undergo such surgery\n5. Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders\n6. Participants with a previous or current history of aspirin-induced asthma'}, 'identificationModule': {'nctId': 'NCT01452750', 'briefTitle': 'Efficacy and Safety of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Non-steroidal Anti-inflammatory Drug (NSAID)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Phase 3, Multicenter, Randomized, Double-blind, AG-1749-controlled, Parallel-group, Comparison Study to Evaluate the Efficacy and Safety of TAK-438 (10 mg or 20 mg, Orally, Once Daily) for the Prevention of Recurrent Gastric or Duodenal Ulcers During Long-term Therapy of Non-steroidal Anti-inflammatory Drug (NSAID).', 'orgStudyIdInfo': {'id': 'TAK-438/CCT-301'}, 'secondaryIdInfos': [{'id': 'U1111-1123-8722', 'type': 'REGISTRY', 'domain': 'WHO'}, {'id': 'JapicCTI-111613', 'type': 'REGISTRY', 'domain': 'JapicCTI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TAK-438 10 mg QD', 'interventionNames': ['Drug: TAK-438', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'TAK-438 20 mg QD', 'interventionNames': ['Drug: TAK-438', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lansoprazole 15 mg QD', 'interventionNames': ['Drug: Lansoprazole', 'Drug: Placebo']}], 'interventions': [{'name': 'TAK-438', 'type': 'DRUG', 'description': 'TAK-438 10 mg tablets, orally, once daily for up to 24 weeks.', 'armGroupLabels': ['TAK-438 10 mg QD']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks.', 'armGroupLabels': ['TAK-438 10 mg QD']}, {'name': 'TAK-438', 'type': 'DRUG', 'description': 'TAK-438 20 mg tablets, orally, once daily for up to 24 weeks.', 'armGroupLabels': ['TAK-438 20 mg QD']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks.', 'armGroupLabels': ['TAK-438 20 mg QD']}, {'name': 'Lansoprazole', 'type': 'DRUG', 'otherNames': ['AG-1749'], 'description': 'Lansoprazole 15 mg capsules, orally, once daily for up to 24 weeks.', 'armGroupLabels': ['Lansoprazole 15 mg QD']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'TAK-438 placebo-matching tablets, orally, once daily for up to 24 weeks.', 'armGroupLabels': ['Lansoprazole 15 mg QD']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kasugai-shi', 'state': 'Aichi-ken', 'country': 'Japan'}, {'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Seto-shi', 'state': 'Aichi-ken', 'country': 'Japan'}, {'city': 'Akita', 'state': 'Akita', 'country': 'Japan', 'geoPoint': {'lat': 39.71667, 'lon': 140.11667}}, {'city': 'Funabashi-shi', 'state': 'Chiba', 'country': 'Japan'}, {'city': 'Ichihara-shi', 'state': 'Chiba', 'country': 'Japan'}, {'city': 'Nagareyama-shi', 'state': 'Chiba', 'country': 'Japan'}, {'city': 'Matsuyama', 'state': 'Ehime', 'country': 'Japan', 'geoPoint': {'lat': 33.83916, 'lon': 132.76574}}, {'city': 'Niihama-shi', 'state': 'Ehime', 'country': 'Japan'}, {'city': 'Saijo-shi', 'state': 'Ehime', 'country': 'Japan'}, {'city': 'Fukui-shi', 'state': 'Fukui', 'country': 'Japan', 'geoPoint': {'lat': 36.06443, 'lon': 136.22257}}, {'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Itoshima-shi', 'state': 'Fukuoka', 'country': 'Japan'}, {'city': 'Kitakyusyu-shi', 'state': 'Fukuoka', 'country': 'Japan'}, {'city': 'Munakata-shi', 'state': 'Fukuoka', 'country': 'Japan'}, {'city': 'Onga-gun', 'state': 'Fukuoka', 'country': 'Japan'}, {'city': 'Tagawa-shi', 'state': 'Fukuoka', 'country': 'Japan'}, {'city': 'Yukuhashi-shi', 'state': 'Fukuoka', 'country': 'Japan'}, {'city': 'Fukushima', 'state': 'Fukushima', 'country': 'Japan', 'geoPoint': {'lat': 37.75, 'lon': 140.46667}}, {'city': 'Koriyama-shi', 'state': 'Fukushima', 'country': 'Japan'}, {'city': 'Gifu', 'state': 'Gifu', 'country': 'Japan', 'geoPoint': {'lat': 35.42291, 'lon': 136.76039}}, {'city': 'Mebashi-shi', 'state': 'Gunma', 'country': 'Japan'}, {'city': 'Takasaki-shi', 'state': 'Gunma', 'country': 'Japan'}, {'city': 'Fukuyama-shi', 'state': 'Hiroshima', 'country': 'Japan'}, {'city': 'Hatsukaichi-shi', 'state': 'Hiroshima', 'country': 'Japan'}, {'city': 'Higashihirosima-shi', 'state': 'Hiroshima', 'country': 'Japan'}, {'city': 'Asahikawa-shi', 'state': 'Hokkaido', 'country': 'Japan'}, {'city': 'Hakodate-shi', 'state': 'Hokkaido', 'country': 'Japan'}, {'city': 'Obihiro-shi', 'state': 'Hokkaido', 'country': 'Japan'}, {'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Sunagawa-shi', 'state': 'Hokkaido', 'country': 'Japan'}, {'city': 'Tomakomai-shi', 'state': 'Hokkaido', 'country': 'Japan'}, {'city': 'Akashi-shi', 'state': 'Hyōgo', 'country': 'Japan'}, {'city': 'Himeji-shi', 'state': 'Hyōgo', 'country': 'Japan'}, {'city': 'Itami-shi', 'state': 'Hyōgo', 'country': 'Japan'}, {'city': 'Kako-gun', 'state': 'Hyōgo', 'country': 'Japan'}, {'city': 'Kato-shi', 'state': 'Hyōgo', 'country': 'Japan'}, {'city': 'Kobe', 'state': 'Hyōgo', 'country': 'Japan', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'city': 'Nishinomiya-shi', 'state': 'Hyōgo', 'country': 'Japan'}, {'city': 'Higashiibaragi-gun', 'state': 'Ibaragi', 'country': 'Japan'}, {'city': 'Koga-shi', 'state': 'Ibaragi', 'country': 'Japan'}, {'city': 'Mito', 'state': 'Ibaragi', 'country': 'Japan', 'geoPoint': {'lat': 36.35, 'lon': 140.45}}, {'city': 'Hitachi-shi', 'state': 'Ibaraki', 'country': 'Japan'}, {'city': 'Hakusan-shi', 'state': 'Ishikawa-ken', 'country': 'Japan'}, {'city': 'Komatsu-shi', 'state': 'Ishikawa-ken', 'country': 'Japan'}, {'city': 'Takamatsu', 'state': 'Kagawa-ken', 'country': 'Japan', 'geoPoint': {'lat': 34.33333, 'lon': 134.05}}, {'city': 'Kamakura-shi', 'state': 'Kanagawa', 'country': 'Japan'}, {'city': 'Kawasaki-shi', 'state': 'Kanagawa', 'country': 'Japan'}, {'city': 'Sagamihara-shi', 'state': 'Kanagawa', 'country': 'Japan'}, {'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'city': 'Kochi', 'state': 'Kochi', 'country': 'Japan', 'geoPoint': {'lat': 33.55, 'lon': 133.53333}}, {'city': 'Kumamoto', 'state': 'Kumamoto', 'country': 'Japan', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'city': 'Uji-shi', 'state': 'Kyoto', 'country': 'Japan'}, {'city': 'Tsu', 'state': 'Mie-ken', 'country': 'Japan', 'geoPoint': {'lat': 34.73333, 'lon': 136.51667}}, {'city': 'Sendai', 'state': 'Miyagi', 'country': 'Japan', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'city': 'Matsumoto-shi', 'state': 'Nagano', 'country': 'Japan'}, {'city': 'Nagano', 'state': 'Nagano', 'country': 'Japan', 'geoPoint': {'lat': 36.65, 'lon': 138.18333}}, {'city': 'Nagasaki', 'state': 'Nagasaki', 'country': 'Japan', 'geoPoint': {'lat': 32.75, 'lon': 129.88333}}, {'city': 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'state': 'Saga-ken', 'country': 'Japan', 'geoPoint': {'lat': 33.23333, 'lon': 130.3}}, {'city': 'Ageo-shi', 'state': 'Saitama', 'country': 'Japan'}, {'city': 'Hiki-gun', 'state': 'Saitama', 'country': 'Japan'}, {'city': 'Kasukabe-shi', 'state': 'Saitama', 'country': 'Japan'}, {'city': 'Kumagaya-shi', 'state': 'Saitama', 'country': 'Japan'}, {'city': 'Saitama-shi', 'state': 'Saitama', 'country': 'Japan'}, {'city': 'Sayama-shi', 'state': 'Saitama', 'country': 'Japan'}, {'city': 'Toda-shi', 'state': 'Saitama', 'country': 'Japan'}, {'city': 'Tokorozawa-shi', 'state': 'Saitama', 'country': 'Japan'}, {'city': 'Ōtsu', 'state': 'Shiga', 'country': 'Japan', 'geoPoint': {'lat': 35.0, 'lon': 135.86667}}, {'city': 'Izumo-shi', 'state': 'Shimane', 'country': 'Japan'}, {'city': 'Hamamatsu', 'state': 'Shizuoka', 'country': 'Japan', 'geoPoint': {'lat': 34.7, 'lon': 137.73333}}, {'city': 'Shizuoka', 'state': 'Shizuoka', 'country': 'Japan', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'city': 'Naruto-shi', 'state': 'Tokushima', 'country': 'Japan'}, {'city': 'Adachi-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Bunkyo-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Hachiouji-shi', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Koto-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Meguro-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Minato-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Mitaka-shi', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Musashimurayama-shi', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Nakano-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Ōta-ku', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.56126, 'lon': 139.71605}}, {'city': 'Setagaya-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Sumida-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Yonago-shi', 'state': 'Tottori', 'country': 'Japan'}, {'city': 'Tonami-shi', 'state': 'Toyama', 'country': 'Japan'}, {'city': 'Toyama', 'state': 'Toyama', 'country': 'Japan', 'geoPoint': {'lat': 36.7, 'lon': 137.21667}}, {'city': 'Shimonoseki-shi', 'state': 'Yamaguchi', 'country': 'Japan'}, {'city': 'Ube-shi', 'state': 'Yamaguchi', 'country': 'Japan'}], 'overallOfficials': [{'name': 'Senior Manager', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}