Four-week Omeprazole Treatment of Non-erosive Reflux Disease in a Japanese Population

This study has been completed.

First Received on November 25, 2005. Last Updated on January 21, 2011 History of Changes

Sponsor:	AstraZeneca
Collaborator:	Mitsubishi Tanabe Pharma Corporation
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00259077

Purpose

The purpose of this study is to study safety and efficacy of omeprazole standard treatment in a Japanese non-erosive reflux disease population.

Condition	Intervention	Phase
Non-erosive Reflux Disease	Drug: Omeprazole	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Double-blind, Randomised, Parallel-group, Multicentre, Phase III Study to Compare the Efficacy of Omeprazole 20mg and 10mg od for the Four-week Treatment of Non-erosive Reflux Disease (NERD) With That of Placebo od and to Investigate Safety

Resource links provided by NLM:

MedlinePlus related topics: GERD Heartburn

Drug Information available for: Omeprazole Omeprazole magnesium Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To determine the efficacy of omeoprazole 20mg and omeprazole 10mg by assessment of complete resolution rate of heartburn during the fourth week of treatment.

Secondary Outcome Measures:

Complete resolution of heartburn during the first and second week of treatment, assessment of sufficient relief rates of heartburn, assessment of nocturnal heartburn, assessment of other GERD symptoms.

Estimated Enrollment:	270
Study Start Date:	October 2003
Study Completion Date:	July 2004
Primary Completion Date:	July 2004 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients who identified their predominant symptom as heartburn and were classifiend as Grande M or N according to Hoshihara's modofied version of Los Angeles Classification at esophagogastroduodenoscopy.

Exclusion Criteria:

Patients with any ongoing gastrointestinal bleeding at the time of esopgahogastroduodenoscopy, patients with any history of erosive esophagitis or any other major diseases or concommittant drugs likely to interfere with the evaluation of this study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00259077

Locations

Japan

Asa, Japan

Beppu, Japan

Chiyoda, Japan

Fujieda, Japan

Fukuoka, Japan

Kanagawa, Japan

Kawagucki, Japan

Kita, Japan

Kitakyushu, Japan

Kyota, Japan

Meguro, Japan

Minato, Japan

Mitsukaido, Japan

Mizumaki, Japan

Nagoya, Japan

Nanao, Japan

Onoda, Japan

Osaka, Japan

Ota, Japan

Otsu, Japan

Sapporo, Japan

Shinagawa, Japan

Shinjuku, Japan

Tokyo, Japan

Ube, Japan

Yukuhashi, Japan

Sponsors and Collaborators

AstraZeneca

Mitsubishi Tanabe Pharma Corporation

Investigators

Study Director:

AstraZeneca Medical Science Director, MD

AstraZeneca

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00259077 History of Changes
Other Study ID Numbers:	D9587C00001, D9584L00002
Study First Received:	November 25, 2005
Last Updated:	January 21, 2011
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:

Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Omeprazole

Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012