Famotidine in Subjects With Non-erosive Gastroesophageal Reflux Disease

Phase 3CompletedNCT00141960

Astellas Pharma Inc480 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

480

Conditions

Gastroesophageal Reflux

Interventions

FamotidineDRUG

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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.

Locations (7)

Unnamed facility

Hokkaido Region, Japan

Unnamed facility

Kanto Region, Japan

Unnamed facility

Kinki Region, Japan

Unnamed facility

Kyushu Region, Japan

Unnamed facility

Shikoku Region, Japan

Outcomes

Primary Outcomes

Rate of days with no heart burn in the treatment period

Secondary Outcomes

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)

Data from ClinicalTrials.gov

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