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Famotidine in Subjects With Non-erosive Gastroesophageal Reflux Disease

NCT ID: NCT00141960

Last Updated: 2011-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Gastroesophageal Reflux

Keywords

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Treatment efficacy Treatment effectiveness Gastrointestinal Diseases Reflux, Gastroesophageal GERD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Famotidine

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Principal Investigators

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Study Director

Role: STUDY_CHAIR

Clinical Development III, Astellas Pharm. Inc.

Locations

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Hokkaido Region, , Japan

Site Status

Kanto Region, , Japan

Site Status

Kinki Region, , Japan

Site Status

Kyushu Region, , Japan

Site Status

Shikoku Region, , Japan

Site Status

Tohoku Region, , Japan

Site Status

Tokai Region, , Japan

Site Status

Countries

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Japan

References

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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. doi: 10.1007/s00535-008-2186-5. Epub 2008 Jul 4.

Reference Type BACKGROUND
PMID: 18600389 (View on PubMed)

Other Identifiers

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1170-CL-004

Identifier Type: -

Identifier Source: org_study_id