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

This study has been completed.
Sponsor:
Collaborator:
Mitsubishi Tanabe Pharma Corporation
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00259077
First received: November 25, 2005
Last updated: January 21, 2011
Last verified: January 2011
  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 3

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 14, 2014