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

Astellas Pharma Inc0 sites480 target enrollmentSeptember 2005

ConditionsGastroesophageal Reflux

DrugsFamotidine

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Gastroesophageal Reflux
Sponsor: Astellas Pharma Inc
Enrollment: 480
Primary Endpoint: Rate of days with no heart burn in the treatment period
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 2005

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Astellas Pharma Inc

Eligibility 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.

Outcomes

Primary Outcomes

Rate of days with no heart burn in the treatment period

Secondary Outcomes

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)