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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00259077
Recruitment Status : Completed
First Posted : November 29, 2005
Last Update Posted : January 24, 2011
Mitsubishi Tanabe Pharma Corporation
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Brief Summary:
The purpose of this study is to study safety and efficacy of omeprazole standard treatment in a Japanese non-erosive reflux disease population.

Condition or disease Intervention/treatment Phase
Non-erosive Reflux Disease Drug: Omeprazole Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : October 2003
Actual Primary Completion Date : July 2004
Actual Study Completion Date : July 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Primary Outcome Measures :
  1. 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 :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00259077

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Asa, Japan
Beppu, Japan
Chiyoda, Japan
Fujieda, Japan
Fukuoka, Japan
Kanagawa, Japan
Kawagucki, Japan
Kitakyushu, Japan
Kita, 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
Mitsubishi Tanabe Pharma Corporation
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Study Director: AstraZeneca Medical Science Director, MD AstraZeneca

Layout table for additonal information Identifier: NCT00259077    
Other Study ID Numbers: D9587C00001
First Posted: November 29, 2005    Key Record Dates
Last Update Posted: January 24, 2011
Last Verified: January 2011
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action