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NCT00259051 Clinical Trial

A Study to Investigate the Pharmacodynamic Effect After Four-week Omeprazole Treatment of Non-erosive Reflux Disease in a Japanese Population

Non-erosive Reflux Disease Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00259051
Other study ID # D9587C00002
Secondary ID D9584L00003
Status Completed
Phase Phase 3
First received November 25, 2005
Last updated January 21, 2011
Start date January 2004
Est. completion date August 2004

Study information
Verified date January 2011
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date August 2004
Est. primary completion date August 2004
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Omeprazole

Locations
Country Name City State
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

Sponsors (2)
Lead Sponsor Collaborator
AstraZeneca Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 To investigate the relation between pharmacodynamic effect and GERD symptoms,to investigate safety
See also
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