Famotidine in Subjects With Non-erosive Gastroesophageal Reflux Disease
Phase 2
Completed
- Conditions
- Gastroesophageal Reflux
- Registration Number
- NCT00141960
- Lead Sponsor
- Astellas Pharma Inc
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 480
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Rate of days with no heart burn in the treatment period
- Secondary Outcome Measures
Name Time Method 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)