Famotidine in Subjects With Non-Erosive Gastroesophageal Reflux Disease
Information source: Astellas Pharma Inc
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastroesophageal Reflux
Intervention: Famotidine (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Astellas Pharma Inc Official(s) and/or principal investigator(s):
Study Director, Study Chair, Affiliation: Clinical Development III, Astellas Pharm. Inc.
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.
Clinical Details
Official title: YM1170 Phase 2/3 Study: A Double Blind, Placebo Controlled, Group-Comparison Study in Patients With Non-Erosive Gastroesophageal Reflux Disease
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Rate of days with no heart burn in the treatment period
Secondary outcome: Disappearance of heart burnSeverity 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)
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Hokkaido region, Japan
Tohoku region, Japan
Kanto region, Japan
Kinki region, Japan
Tokai region, Japan
Shikoku region, Japan
Kyushu region, Japan
Additional Information
Starting date: September 2005
Last updated: October 18, 2007
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