Famotidine in Subjects With Non-erosive Gastroesophageal Reflux Disease
YM1170 Phase 2/3 Study: A Double Blind, Placebo Controlled, Group-comparison Study in Patients With Non-erosive Gastroesophageal Reflux Disease
1 other identifier
interventional
480
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2005
CompletedStudy Start
First participant enrolled
September 1, 2005
CompletedFirst Posted
Study publicly available on registry
September 2, 2005
CompletedNovember 21, 2011
June 1, 2010
September 1, 2005
November 18, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of days with no heart burn in the treatment period
Secondary Outcomes (5)
Disappearance of heart burn
Severity of heart burn
Frequency of heart burn
Patient's final global improvement rating
Other symptoms (e.g.,reflux sensation of gastric fluid, discomfort of pharynges)
Interventions
Eligibility Criteria
You may qualify if:
- Patients have heartburn with non-erosive gastroesophageal reflux disease.
You may not qualify if:
- Patients have diseases which interfere with evaluation of the efficacy and safety in this study.
- 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.
- Patients have severe cardiovascular, hepatic, renal and hematological disorders.
- Patients are allergic to or have a history of drug allergy to H2RA.
- Patients have or have a history of malignant tumors.
- Patients are pregnant or a lactating mother.
- Patients have participated in other clinical studies less than 12 weeks prior to submitting the informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Unknown Facility
Hokkaido Region, Japan
Unknown Facility
Kanto Region, Japan
Unknown Facility
Kinki Region, Japan
Unknown Facility
Kyushu Region, Japan
Unknown Facility
Shikoku Region, Japan
Unknown Facility
Tohoku Region, Japan
Unknown Facility
Tokai Region, Japan
Related Publications (1)
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.
PMID: 18600389BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Study Director
Clinical Development III, Astellas Pharm. Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 1, 2005
First Posted
September 2, 2005
Study Start
September 1, 2005
Last Updated
November 21, 2011
Record last verified: 2010-06