Four-week omeprazole treatment of non-erosive reflux disease in a Japanese population

Study identifier:D9587C00001

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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

Medical condition

Non-erosive reflux disease

Phase

Phase 3

Healthy volunteers

No

Study drug

Omeprazole

Sex

All

Actual Enrollment

270

Study type

Interventional

Age

20 Years +

Date

Study Start Date: 01 Oct 2003
Primary Completion Date: 01 Jul 2004
Study Completion Date: 01 Jul 2004

Study design

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Jan 2011 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

Mitsubishi Pharma Corporation

Inclusion and exclusion criteria