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Famotidine in Subjects With Non-erosive Gastroesophageal Reflux Disease

Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Gastroesophageal Reflux

Intervention: Famotidine (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
Study Director, Study Chair, Affiliation: Clinical Development III, Astellas Pharm. Inc.

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.

Clinical Details

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

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

Primary outcome: Rate of days with no heart burn in the treatment period

Secondary outcome:

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

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 and Contacts

Hokkaido region, Japan

Kanto region, Japan

Kinki region, Japan

Kyushu region, Japan

Shikoku region, Japan

Tohoku region, Japan

Tokai region, Japan

Additional Information

Related publications:

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.

Starting date: September 2005
Last updated: November 18, 2011

Page last updated: August 23, 2015

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