PPI Test in GP Patients

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: GERD

Treatments: Drug: Esomeprazole; Procedure: Ambulatory 24-hour esophageal pH-monitoring

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00318084

25N54

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)