Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 2:53 AM
Study NCT ID:
NCT00141960
Status:
COMPLETED
Last Update Posted:
2011-11-21
First Post:
2005-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Famotidine in Subjects With Non-erosive Gastroesophageal Reflux Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015738', 'term': 'Famotidine'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 480}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'lastUpdateSubmitDate': '2011-11-18', 'studyFirstSubmitDate': '2005-09-01', 'studyFirstSubmitQcDate': '2005-09-01', 'lastUpdatePostDateStruct': {'date': '2011-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of days with no heart burn in the treatment period'}], 'secondaryOutcomes': [{'measure': 'Disappearance of heart burn'}, {'measure': 'Severity of heart burn'}, {'measure': 'Frequency of heart burn'}, {'measure': "Patient's final global improvement rating"}, {'measure': 'Other symptoms (e.g.,reflux sensation of gastric fluid, discomfort of pharynges)'}]}, 'conditionsModule': {'keywords': ['Treatment efficacy', 'Treatment effectiveness', 'Gastrointestinal Diseases', 'Reflux, Gastroesophageal', 'GERD'], 'conditions': ['Gastroesophageal Reflux']}, 'referencesModule': {'references': [{'pmid': '18600389', 'type': 'BACKGROUND', 'citation': 'Hongo M, Kinoshita Y, Haruma K. A randomized, double-blind, placebo-controlled clinical study of the histamine H2-receptor antagonist famotidine in Japanese patients with nonerosive reflux disease. J Gastroenterol. 2008;43(6):448-56. doi: 10.1007/s00535-008-2186-5. Epub 2008 Jul 4.'}]}, 'descriptionModule': {'briefSummary': 'Gastroesophageal reflux disease (GERD) considered to be associated with mucosal damages in the esophagus and heartburn, which may sometimes interfere with daily activities due likely to reflux of acid gastric contents. While most of the patients given the diagnosis of GERD do not exhibit endoscopically obvious impairment in esophageal mucous membrane, they have subjective symptoms of non-erosive GERD including heartburn. But no drug has been launched in Japan, which targets non-erosive GERD. This study will examine the efficacy and safety of famotidine in subjects with non-erosive GERD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients have heartburn with non-erosive gastroesophageal reflux disease.\n\nExclusion Criteria:\n\n* Patients have diseases which interfere with evaluation of the efficacy and safety in this study.\n* Patients are receiving and/or have received prior to the enrollment the treatment which interfere with evaluation of the efficacy and safety in this study.\n* Patients have severe cardiovascular, hepatic, renal and hematological disorders.\n* Patients are allergic to or have a history of drug allergy to H2RA.\n* Patients have or have a history of malignant tumors.\n* Patients are pregnant or a lactating mother.\n* Patients have participated in other clinical studies less than 12 weeks prior to submitting the informed consent.'}, 'identificationModule': {'nctId': 'NCT00141960', 'briefTitle': 'Famotidine in Subjects With Non-erosive Gastroesophageal Reflux Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'YM1170 Phase 2/3 Study: A Double Blind, Placebo Controlled, Group-comparison Study in Patients With Non-erosive Gastroesophageal Reflux Disease', 'orgStudyIdInfo': {'id': '1170-CL-004'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Famotidine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hokkaido Region', 'country': 'Japan'}, {'city': 'Kanto Region', 'country': 'Japan'}, {'city': 'Kinki Region', 'country': 'Japan'}, {'city': 'Kyushu Region', 'country': 'Japan'}, {'city': 'Shikoku Region', 'country': 'Japan'}, {'city': 'Tohoku Region', 'country': 'Japan'}, {'city': 'Tokai Region', 'country': 'Japan'}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_CHAIR', 'affiliation': 'Clinical Development III, Astellas Pharm. Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}}}}