PPI Test in GP Patients

AstraZeneca100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

GERD

Interventions

EsomeprazoleDRUG

Ambulatory 24-hour esophageal pH-monitoringPROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (1)

Research Site

Utrecht, Netherlands

Outcomes

Primary Outcomes

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 Outcomes

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.

Data from ClinicalTrials.gov

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