Four-Week Omeprazole Treatment of Non-Erosive Reflux Disease in a Japanese Population

This study has been completed.

First Received: November 25, 2005 No Changes Posted

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:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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: Heartburn

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

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

Eligibility

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

Sponsors and Collaborators

AstraZeneca

Mitsubishi Tanabe Pharma Corporation

Investigators

Study Director:

AstraZeneca Medical Science Director, MD

AstraZeneca

More Information

No publications provided

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

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents

Omeprazole
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010