PPI Test in GP Patients

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00318084

Collaborator

UMC Utrecht (Other)

100

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
GERD	Drug: Esomeprazole Procedure: Ambulatory 24-hour esophageal pH-monitoring	Phase 4

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2003

Outcome Measures

Primary Outcome Measures

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

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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