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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00141960

Enrollment

480

Registered

2005-09-02

Start date

2005-09-30

Completion date

Unknown

Last updated

2011-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux

Keywords

Treatment efficacy, Treatment effectiveness, Gastrointestinal Diseases, Reflux, Gastroesophageal, GERD

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.

Interventions

DRUGFamotidine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Rate of days with no heart burn in the treatment period	—

Secondary

Measure	Time frame
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)	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026