PPI Test in GP Patients
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: GERD
Intervention: Esomeprazole (Drug); Ambulatory 24-hour esophageal pH-monitoring (Procedure)
Phase: Phase 4
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s): AstraZeneca Netherlands Medical Director, Study Director, Affiliation: AstraZeneca
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.
Clinical Details
Official title: The Proton Pump Inhibitor Test in Reflux Disease: a Study Using Nexium in General Practice Patients
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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: 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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Research Site, Utrecht, Netherlands
Additional Information
Starting date: January 2003
Last updated: August 15, 2007
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