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.

Sponsors and Collaborators:	AstraZeneca Mitsubishi Tanabe Pharma Corporation
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00259051

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 III

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Uncontrolled, Parallel Assignment, Efficacy Study
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).

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:	November 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. 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

Sponsors and Collaborators

AstraZeneca

Mitsubishi Tanabe Pharma Corporation

Investigators

Study Director:

AstraZeneca Japan Medical Director, MD

AstraZeneca

More Information

Study ID Numbers:	D9584L00003, D9587C00002
Study First Received:	November 25, 2005
Last Updated:	November 25, 2005
ClinicalTrials.gov Identifier:	NCT00259051
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Omeprazole

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Anti-Ulcer Agents

Gastrointestinal Agents
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009