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A Study to Investigate the Pharmacodynamic Effect After 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:
NCT00259051
First received: November 25, 2005
Last updated: January 21, 2011
Last verified: January 2011
History of Changes
  Purpose

The purpose of this study is to investigate the pharmacodynamic effect of omeprazole n 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 Investigate the Pharmacodynamic Effect by Assessment of the 24 Hours Intraesophageal pH Level, the Efficacy and Safety of Omeprazole 10mg and 20mg od in Patients With Non-erosive Reflux Disease (NERD).

Resource links provided by NLM:

MedlinePlus related topics: GERD
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To investigate the pharmacodynamic effect of omeprazole 10mg and 20mg od in patients with NERD, by assessment of the change of the percentage of time with intra-esophageal pH <4 during 24 hours.

Secondary Outcome Measures:
  • To investigate the relation between pharmacodynamic effect and GERD symptoms,to investigate safety

Estimated Enrollment: 40
Study Start Date: January 2004
Study Completion Date: August 2004
Primary Completion Date: August 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. Written informed consent, ability to comply with study instructions

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: NCT00259051

Locations
Japan
Research Site
Ashahikawa, Japan
Research Site
Fukuoka, Japan
Research Site
Hiroshima, Japan
Research Site
Ichihara, Japan
Research Site
Kochi, Japan
Research Site
Koshigaya, Japan
Research Site
Kurashiki, Japan
Research Site
Nakano, Japan
Research Site
Nerima-ku, Japan
Research Site
Oita, Japan
Research Site
Osaka, Japan
Research Site
Sapporo, Japan
Research Site
Yamato, Japan
Sponsors and Collaborators
AstraZeneca
Mitsubishi Tanabe Pharma Corporation
Investigators
Study Director: AstraZeneca Japan Medical Director, MD AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00259051     History of Changes
Other Study ID Numbers: D9587C00002, D9584L00003
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 May 21, 2013