Famotidine in Subjects With Non-erosive Gastroesophageal Reflux Disease - Full Text View

Sponsor:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00141960

Purpose

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.

Condition	Intervention	Phase
Gastroesophageal Reflux	Drug: Famotidine	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	YM1170 Phase 2/3 Study: A Double Blind, Placebo Controlled, Group-comparison Study in Patients With Non-erosive Gastroesophageal Reflux Disease

Resource links provided by NLM:

MedlinePlus related topics: Burns GERD Heartburn

Drug Information available for: Famotidine

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Rate of days with no heart burn in the treatment period

Secondary Outcome 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)

Estimated Enrollment:	480
Study Start Date:	September 2005

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00141960

Locations

Japan

Hokkaido region, Japan

Kanto region, Japan

Kinki region, Japan

Kyushu region, Japan

Shikoku region, Japan

Tohoku region, Japan

Tokai region, Japan

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Chair:

Study Director

Clinical Development III, Astellas Pharm. Inc.

More Information

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. Epub 2008 Jul 4.

ClinicalTrials.gov Identifier:	NCT00141960 History of Changes
Other Study ID Numbers:	1170-CL-004
Study First Received:	September 1, 2005
Last Updated:	November 18, 2011
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Astellas Pharma Inc:

Treatment efficacy
Treatment effectiveness
Gastrointestinal Diseases
Reflux, Gastroesophageal
GERD

Additional relevant MeSH terms:

Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Famotidine
Anti-Ulcer Agents
Gastrointestinal Agents

Therapeutic Uses
Pharmacologic Actions
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012