Official Title: “YM1170 Phase 2/3 Study: A Double Blind, Placebo Controlled, Group-Comparison Study in Patients With Non-Erosive Gastroesophageal Reflux Disease”

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

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Famotidine

Primary Measures

• Rate of days with no heart burn in the treatment period

Secondary 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)

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Astellas Pharma Inc

Overall Clinical Trial Officials and Contacts

Study Director Study Chair Clinical Development III, Astellas Pharm. Inc.  

Information obtained from ClinicalTrials.gov on January 06, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00141960

Study ID Number: 170-CL-004

ClinicalTrials.gov Identifier: NCT00141960

Health Authority: Japan: Ministry of Health, Labor and Welfare

Link to results on ClinicalStudyResults.org