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NCT00318084 Clinical Trial

PPI Test in GP Patients

GERD Clinical Trial

Official title:
The Proton Pump Inhibitor Test in Reflux Disease: a Study Using Nexium in General Practice Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00318084
Other study ID # 25N54
Secondary ID
Status Completed
Phase Phase 4
First received April 25, 2006
Last updated August 15, 2007
Start date January 2003

Study information
Verified date August 2007
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the diagnostic value of two week treatment with Nexium as a confirmatory test for patients with suspected reflux disease.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age = 18 years

- Symptoms suggestive for gastric acid reflux disease during 2 or more days per week

Exclusion Criteria:

- Treatment with prokinetic or acid secretion inhibitors within 4 weeks prior to inclusion

- Treatment with a PPI for more than 30 days within the last 3 months prior to inclusion

- History of proven peptic ulcer disease, unless successfully treated with Helicobacter pylori eradication longer than 1 month before inclusion

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Esomeprazole

Procedure:
• Ambulatory 24-hour esophageal pH-monitoring

Locations
Country Name City State
Netherlands Research Site Utrecht

Sponsors (2)
Lead Sponsor Collaborator
AstraZeneca UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Diagnostic test characteristics and the positive and negative predictive value of a 2-week Nexium-based PPI test using symptom analysis of 24-hour esophageal pH monitoring as gold standard.
Secondary To assess the optimal duration of a Nexium-based PPI test, and the predictive value of different symptoms for presence of reflux-related symptoms.
Secondary Obtain information on patient satisfaction, the course of reflux symptoms, the consumption of acid suppressing drugs, the disease-related quality of life at a follow up periods of 3 months in patients with a positive and negative PPI test.
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