Famotidine in Subjects With Non-erosive Gastroesophageal Reflux Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00141960
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : November 21, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Drug: Famotidine Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD Heartburn
U.S. FDA Resources

Primary Outcome Measures :
  1. Rate of days with no heart burn in the treatment period

Secondary Outcome Measures :
  1. Disappearance of heart burn
  2. Severity of heart burn
  3. Frequency of heart burn
  4. Patient's final global improvement rating
  5. Other symptoms (e.g.,reflux sensation of gastric fluid, discomfort of pharynges)

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00141960

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

Publications: Identifier: NCT00141960     History of Changes
Other Study ID Numbers: 1170-CL-004
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: November 21, 2011
Last Verified: June 2010

Keywords provided by Astellas Pharma Inc:
Treatment efficacy
Treatment effectiveness
Gastrointestinal Diseases
Reflux, Gastroesophageal

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs