Back to resultsFamotidine in Subjects With Non-erosive Gastroesophageal Reflux Disease
Primary Purpose
Gastroesophageal Reflux
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Famotidine
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux focused on measuring Treatment efficacy, Treatment effectiveness, Gastrointestinal Diseases, Reflux, Gastroesophageal, GERD
Eligibility Criteria
Inclusion Criteria: Patients have heartburn with non-erosive gastroesophageal reflux disease. Exclusion Criteria: 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.
Sites / Locations
Outcomes
Primary Outcome Measures
Rate of days with no heart burn in the treatment period
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT00141960
First Posted
September 1, 2005
Last Updated
November 18, 2011
Sponsor
Astellas Pharma Inc
1. Study Identification
Unique Protocol Identification Number
NCT00141960
Brief Title
Famotidine in Subjects With Non-erosive Gastroesophageal Reflux Disease
Official Title
YM1170 Phase 2/3 Study: A Double Blind, Placebo Controlled, Group-comparison Study in Patients With Non-erosive Gastroesophageal Reflux Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux
Keywords
Treatment efficacy, Treatment effectiveness, Gastrointestinal Diseases, Reflux, Gastroesophageal, GERD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
480 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Famotidine
Primary Outcome Measure Information:
Title
Rate of days with no heart burn in the treatment period
Secondary Outcome Measure Information:
Title
Disappearance of heart burn
Title
Severity of heart burn
Title
Frequency of heart burn
Title
Patient's final global improvement rating
Title
Other symptoms (e.g.,reflux sensation of gastric fluid, discomfort of pharynges)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients have heartburn with non-erosive gastroesophageal reflux disease.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Clinical Development III, Astellas Pharm. Inc.
Official's Role
Study Chair
Facility Information:
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
18600389
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.
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Famotidine in Subjects With Non-erosive Gastroesophageal Reflux Disease
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