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Sponsored by: |
Astellas Pharma Inc |
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Information provided by: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00141960 |
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: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | YM1170 Phase 2/3 Study: A Double Blind, Placebo Controlled, Group-Comparison Study in Patients With Non-Erosive Gastroesophageal Reflux Disease |
Estimated Enrollment: | 480 |
Study Start Date: | September 2005 |
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Japan | |
Hokkaido region, Japan | |
Tohoku region, Japan | |
Kanto region, Japan | |
Kyushu region, Japan | |
Tokai region, Japan | |
Shikoku region, Japan | |
Kinki region, Japan |
Study Chair: | Study Director | Clinical Development III, Astellas Pharm. Inc. |
Study ID Numbers: | 170-CL-004 |
Study First Received: | September 1, 2005 |
Last Updated: | June 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00141960 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Treatment efficacy Treatment effectiveness Gastrointestinal Diseases Reflux, Gastroesophageal GERD |
Deglutition Disorders Esophageal Motility Disorders Digestive System Diseases Famotidine Esophageal disorder |
Gastrointestinal Diseases Histamine phosphate Esophageal Diseases Gastroesophageal Reflux Histamine |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Histamine Antagonists Therapeutic Uses Physiological Effects of Drugs |
Anti-Ulcer Agents Gastrointestinal Agents Histamine Agents Histamine H2 Antagonists Pharmacologic Actions |