A study to investigate the pharmacodynamic effect after four-week omeprazole treatment of non-erosive reflux disease in a Japanese population
Study identifier:D9587C00002
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 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).
Medical condition
Non-erosive reflux disease
Phase
Phase 3
Healthy volunteers
No
Study drug
Omeprazole
Sex
All
Actual Enrollment
40
Study type
Interventional
Age
20 Years +
Date
Study Start Date: 01 Jan 2004
Primary Completion Date: 01 Aug 2004
Study Completion Date: 01 Aug 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
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No locations available
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Contacts
Investigators
Principal Investigator
AstraZeneca Japan Medical Director
AstraZeneca
