Famotidine in Subjects With Non-erosive Gastroesophageal Reflux Disease

Gastroesophageal Reflux Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00141960
• Other study ID #: 1170-CL-004
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 1, 2005
• Last updated: November 18, 2011
• Start date: September 2005

Study information

• Verified date: June 2010
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux

Intervention

Drug:
• Famotidine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of days with no heart burn in the treatment period
Secondary	Disappearance of heart burn
Secondary	Severity of heart burn
Secondary	Frequency of heart burn
Secondary	Patient's final global improvement rating
Secondary	Other symptoms (e.g.,reflux sensation of gastric fluid, discomfort of pharynges)