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 Gastrointestinal Diseases Reflux, Gastroesophageal GERD	Drug: Famotidine	Phase II Phase III

Ages Eligible for Study:  20 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Patients have heartburn with non-erosive gastroesophageal reflux disease.

Exclusion Criteria:

• Patients have deseases 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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00141960

Astellas Pharm. Inc.       clinicaltrials_info@jp.astellas.com

Japan
      Hokkaido region,  Japan; Not yet recruiting
      Tohoku region,  Japan; Recruiting
      Kanto region,  Japan; Not yet recruiting
      Kinki region,  Japan; Not yet recruiting
      Tokai region,  Japan; Not yet recruiting
      Shikoku region,  Japan; Not yet recruiting
      Kyushu region,  Japan; Not yet recruiting

Study chairs or principal investigators

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

Study ID Numbers:  170-CL-004
Last Updated:  September 1, 2005
Record first received:  September 1, 2005
ClinicalTrials.gov Identifier:  NCT00141960
Health Authority: Japan: Ministry of Health, Labor and Welfare
ClinicalTrials.gov processed this record on 2005-09-06