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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

Page last updated: August 23, 2015

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