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

January 21, 2011 updated by: AstraZeneca

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

270

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

Mitsubishi Tanabe Pharma Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (Actual)

July 1, 2004

Study Completion (Actual)

July 1, 2004

Study Registration Dates

First Submitted

November 25, 2005

First Submitted That Met QC Criteria

November 25, 2005

First Posted (Estimate)

November 29, 2005

Study Record Updates

Last Update Posted (Estimate)

January 24, 2011

Last Update Submitted That Met QC Criteria

January 21, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D9587C00001
  • D9584L00002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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