PPI Test in GP Patients

Phase 4

Completed

• Conditions: GERD

• Registration Number: NCT00318084
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01
• Study First Submitted: 2006-04-25
• Study First Submitted QC: 2006-04-25
• Study First Posted: 2006-04-26
• Status Verified: 2007-08
• Last Update Submitted: 2007-08-15
• Last Update Posted: 2007-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
To assess the optimal duration of a Nexium-based PPI test, and the predictive value of different symptoms for presence of reflux-related symptoms.
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.

Trial Locations

Locations (1)

Research Site; 🇳🇱 Utrecht, Netherlands