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Completed

NCT Number: NCT00141960

Famotidine in Subjects With Non-erosive Gastroesophageal Reflux Disease

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.

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Key information

Conditions

Gastroesophageal Reflux Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastrointestinal Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hokkaido Region, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Famotidine

Drug

Primary outcomes

  1. Rate of days with no heart burn in the treatment period

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2005
First posted
Sep 2, 2005
Registry last updated
Nov 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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