Famotidine in Subjects With Non-erosive Gastroesophageal Reflux Disease

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT00141960

Collaborator

(none)

480

Enrollment

Locations

68.6

Patients Per Site

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gastroesophageal Reflux	Drug: Famotidine	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

YM1170 Phase 2/3 Study: A Double Blind, Placebo Controlled, Group-comparison Study in Patients With Non-erosive Gastroesophageal Reflux Disease

Study Start Date :

Sep 1, 2005

Outcome Measures

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) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.