Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-31 @ 4:46 AM
Study NCT ID:
NCT01474369
Status:
COMPLETED
Last Update Posted:
2013-07-03
First Post:
2011-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of TAK-438 Compared to Placebo in the Treatment of Non-Erosive Gastroesophageal Reflux Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C552956', 'term': '1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine'}]}}, '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': 827}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-02', 'studyFirstSubmitDate': '2011-10-24', 'studyFirstSubmitQcDate': '2011-11-15', 'lastUpdatePostDateStruct': {'date': '2013-07-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of symptom-free days of heartburn symptoms', 'timeFrame': 'Week 4', 'description': 'Heartburn symptoms will be collected by participant diaries.'}, {'measure': 'Cumulative symptom improvement rate of heartburn symptoms', 'timeFrame': 'Week 4', 'description': 'Heartburn symptoms will be collected by participant diaries.'}, {'measure': 'Severity of heartburn symptoms', 'timeFrame': 'Week 4', 'description': 'Heartburn symptoms will be collected by participant diaries.'}], 'secondaryOutcomes': [{'measure': 'Heartburn symptoms stratified by response (improvement or non-improvement) at Week 2', 'timeFrame': 'Week 4', 'description': 'Heartburn symptoms will be collected by participant diaries. Percentage of symptom-free days, cumulative symptom improvement rate, and severity of heartburn symptoms are evaluation parameters.'}, {'measure': 'Heartburn Symptoms Stratified by Baseline Endoscopic Findings (Grade N or M)', 'timeFrame': 'Week 4', 'description': 'Heartburn symptoms collected by participant diaries. Percentage of symptom-free days, cumulative symptom improvement rate and severity of heartburn symptoms=evaluation parameters. Participants with Non-Erosive Gastroesophageal Reflux Disease divided into Grade N (endoscopically normal) and M (minimal change) by modified Los Angeles Classification System. Grade definitions: Grade N (endoscopically normal), M (minimal change), A (Mucosal break \\<5 mm) B (Mucosal break ≥5 mm) C (Mucosal break continuous between 2 or more folds and \\<75% of circumference) and D (Mucosal break ≥75% of circumference).'}, {'measure': 'Heartburn symptoms stratified by combination of response at Week 2 and baseline endoscopic findings (improvement and grade N, improvement and grade M, non-improvement and grade N, non-improvement and grade M.)', 'timeFrame': 'Week 4', 'description': 'Heartburn symptoms will be collected by participant diaries. Percentage of symptom-free days, cumulative symptom improvement rate, and severity of heartburn symptoms are evaluation parameters.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Drug Therapy'], 'conditions': ['Non-erosive Gastroesophageal Reflux Disease']}, 'referencesModule': {'references': [{'pmid': '28119763', 'type': 'DERIVED', 'citation': 'Kinoshita Y, Sakurai Y, Shiino M, Kudou K, Nishimura A, Miyagi T, Iwakiri K, Umegaki E, Ashida K. Evaluation of the Efficacy and Safety of Vonoprazan in Patients with Nonerosive Gastroesophageal Reflux Disease: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study. Curr Ther Res Clin Exp. 2016 Dec 21;81-82:1-7. doi: 10.1016/j.curtheres.2016.12.001. eCollection 2016.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the superiority of efficacy of TAK-438, once daily (QD), to placebo in patients with non-erosive gastroesophageal reflux disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Participants with grade N or M in the modified LA classification system confirmed by endoscopy at initiation of the pre-observation period (VISIT 1).\n2. Participants with repeated acid reflux symptoms (heartburn or regurgitation) for 2 days or more in one week in the 3 weeks before initiation of initiation of the pre-observation period (VISIT 1).\n3. Participants with severity\\* of moderate or higher for acid reflux symptoms (heartburn or regurgitation) in the 3 weeks before initiation of the pre-observation period (VISIT 1)\n\n \\* Severity: No symptoms, very mild (symptoms present but often forgotten), mild (not so painful), moderate (rather painful), severe (painful) and very severe (painful enough to affect night time sleep or daily activities)\n4. Outpatients (hospitalization for testing possible)\n\nExclusion Criteria:\n\n1. Participants with an esophagus-related complication \\[Barrett's esophagus (3 cm or more, LSBE), eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infections, esophageal stenosis, etc.\\], or a history of radiotherapy or cryotherapy of the esophagus, a caustic or physiochemical trauma (esophageal sclerotherapy, etc.). However, participants with Barrett's esophagus (less than 3 cm, SSBE) or Schatzki's ring (mucosal tissue ring around inferior esophageal sphincter) are allowed to be included.\n2. Participants who have received surgery or treatment affecting gastroesophageal reflux (cardioplasty, dilation of esophageal stenosis \\[excluding Schatzki's ring\\], etc.), or who have a history of surgery of stomach or duodenum (excluding removal of benign polyp under endoscopy)\n3. Participants who have acute upper gastrointestinal bleeding, gastric ulcers (mucosal defects associated with white coating) or duodenal ulcers (mucosal defect with white coating) within 30 days before initiation of the pre-observation period (VISIT 1) However, participants with gastric or duodenal erosions are allowed to be included.\n4. Participants with acute gastritis or acute exacerbation of chronic gastritis as a complication\n5. Participants with a previous or current history of the Zollinger-Ellison syndrome or other gastric acid hypersecretion disorders\n6. Participants with a history of chest pain due to heart disease or with chest pains suspected of being caused by heart disease within one year before initiation of the pre-observation period (VISIT 1)"}, 'identificationModule': {'nctId': 'NCT01474369', 'briefTitle': 'Efficacy of TAK-438 Compared to Placebo in the Treatment of Non-Erosive Gastroesophageal Reflux Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Phase 3, Randomized, Double Blind, Placebo Control, Multicenter Study to Evaluate the Efficacy and Safety of TAK- 438 (10 and 20 mg Once-Daily) in Patients With Non-Erosive Gastroesophageal Reflux Disease.', 'orgStudyIdInfo': {'id': 'TAK-438/CCT-201'}, 'secondaryIdInfos': [{'id': 'U1111-1125-1115', 'type': 'REGISTRY', 'domain': 'WHO'}, {'id': 'JapicCTI-111663', 'type': 'REGISTRY', 'domain': 'JapicCTI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TAK-438 10 mg QD', 'interventionNames': ['Drug: TAK-438']}, {'type': 'EXPERIMENTAL', 'label': 'TAK-438 20 mg QD', 'interventionNames': ['Drug: TAK-438']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo QD', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'TAK-438', 'type': 'DRUG', 'description': 'TAK-438 10 mg, tablets, orally, once daily for 4 weeks. Thereafter, TAK-438 placebo tablets, orally, once daily for 1 week.', 'armGroupLabels': ['TAK-438 10 mg QD']}, {'name': 'TAK-438', 'type': 'DRUG', 'description': 'TAK-438 20 mg, tablets, orally, once daily for 4 weeks. Thereafter, TAK-438 placebo tablets, orally, once daily for 1 week.', 'armGroupLabels': ['TAK-438 20 mg QD']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'TAK-438 placebo-matching tablets, orally, once daily for 5 weeks.', 'armGroupLabels': ['Placebo QD']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Abiko-shi', 'state': 'Chiba', 'country': 'Japan'}, {'city': 'Kashiwa-shi', 'state': 'Chiba', 'country': 'Japan'}, {'city': 'Noda', 'state': 'Chiba', 'country': 'Japan', 'geoPoint': {'lat': 35.94897, 'lon': 139.86793}}, {'city': 'Yachiyo-shi', 'state': 'Chiba', 'country': 'Japan'}, {'city': 'Saijo-shi', 'state': 'Ehime', 'country': 'Japan'}, {'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Itoshima-shi', 'state': 'Fukuoka', 'country': 'Japan'}, {'city': 'Kasuya-gun', 'state': 'Fukuoka', 'country': 'Japan'}, {'city': 'Onga-gun', 'state': 'Fukuoka', 'country': 'Japan'}, {'city': 'Kouriyama-shi', 'state': 'Fukushima', 'country': 'Japan'}, {'city': 'Gifu', 'state': 'Gifu', 'country': 'Japan', 'geoPoint': {'lat': 35.42291, 'lon': 136.76039}}, {'city': 'Takayama-shi', 'state': 'Gifu', 'country': 'Japan'}, {'city': 'Annaka-shi', 'state': 'Gunma', 'country': 'Japan'}, {'city': 'Hiroshima', 'state': 'Hiroshima', 'country': 'Japan', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'city': 'Asahikawa-shi', 'state': 'Hokkaido', 'country': 'Japan'}, {'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Amagasaki-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': 'Takarazuka-shi', 'state': 'Hyōgo', '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': 'Suzaki-shi', 'state': 'Kochi', 'country': 'Japan'}, {'city': 'Kumamoto', 'state': 'Kumamoto', 'country': 'Japan', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'city': 'Kyoto', 'state': 'Kyoto', 'country': 'Japan', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'city': 'Sendai', 'state': 'Miyagi', 'country': 'Japan', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'city': 'Nagasaki', 'state': 'Nagasaki', 'country': 'Japan', 'geoPoint': {'lat': 32.75, 'lon': 129.88333}}, {'city': 'Ōita', 'state': 'Oita Prefecture', 'country': 'Japan', 'geoPoint': {'lat': 33.23333, 'lon': 131.6}}, {'city': 'Okayama', 'state': 'Okayama-ken', 'country': 'Japan', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Takatsuki-shi', 'state': 'Osaka', 'country': 'Japan'}, {'city': 'Saga', 'state': 'Saga-ken', 'country': 'Japan', 'geoPoint': {'lat': 33.23333, 'lon': 130.3}}, {'city': 'Kumagaya-shi', 'state': 'Saitama', 'country': 'Japan'}, {'city': 'Saitama-shi', 'state': 'Saitama', 'country': 'Japan'}, {'city': 'Tokorozawa-shi', 'state': 'Saitama', 'country': 'Japan'}, {'city': 'Otawara-shi', 'state': 'Tochigi', 'country': 'Japan'}, {'city': 'Bunkyo-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Chiyoda-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Chuo-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Hachioji-shi', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Kokubunji-shi', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Nakano-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Oota-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Setagaya-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Shibuya-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Shinjuku-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Shimonoseki-shi', 'state': 'Yamaguchi', 'country': 'Japan'}, {'city': 'Kofu', 'state': 'Yamanashi', 'country': 'Japan', 'geoPoint': {'lat': 35.66667, 'lon': 138.56667}}, {'city': 'Turu-shi', 'state': 'Yamanashi', 'country': 'Japan'}, {'city': 'Yamagata', 'state': 'Ymagata', 'country': 'Japan', 'geoPoint': {'lat': 38.23333, 'lon': 140.36667}}], 'overallOfficials': [{'name': 'Senior Manager', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}