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Famotidine in Subjects With Non-erosive Gastroesophageal Reflux Disease

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00141960
First received: September 1, 2005
Last updated: November 18, 2011
Last verified: June 2010
History of Changes

September 1, 2005
November 18, 2011
September 2005
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Rate of days with no heart burn in the treatment period
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Complete list of historical versions of study NCT00141960 on ClinicalTrials.gov Archive Site
  • 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)
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Famotidine in Subjects With Non-erosive Gastroesophageal Reflux Disease
YM1170 Phase 2/3 Study: A Double Blind, Placebo Controlled, Group-comparison Study in Patients 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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Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Gastroesophageal Reflux
Drug: Famotidine
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
480
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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.
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00141960
1170-CL-004
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Astellas Pharma Inc
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Study Chair: Study Director Clinical Development III, Astellas Pharm. Inc.
Astellas Pharma Inc
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP