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

November 25, 2005
January 21, 2011
January 2004
August 2004   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT00259051 on ClinicalTrials.gov Archive Site
To investigate the relation between pharmacodynamic effect and GERD symptoms,to investigate safety
Same as current
Not Provided
Not Provided
 
A Study to Investigate the Pharmacodynamic Effect After Four-week Omeprazole Treatment of Non-erosive Reflux Disease in a Japanese Population
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).

The purpose of this study is to investigate the pharmacodynamic effect of omeprazole n a Japanese non-erosive reflux disease population

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Non-erosive Reflux Disease
Drug: Omeprazole
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
August 2004
August 2004   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00259051
D9587C00002, D9584L00003
Not Provided
Not Provided
AstraZeneca
Mitsubishi Tanabe Pharma Corporation
Study Director: AstraZeneca Japan Medical Director, MD AstraZeneca
AstraZeneca
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP