Symptom Adapted Therapy in GERD Patients

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to determine whether a maintenance treatment over 12 weeks with esomeprazole 20 mg daily will sufficiently give control over GERD symptoms and how it compares either with an on-demand therapy with esomeprazole 20 mg or an as needed therapy (wait and see regimen) with rescue medication only (antacid), following a 4-weeks acute treatment phase with either esomeprazole 20 mg or esomeprazole 40 mg.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Aluminum Hydroxide; Esomeprazole; Magnesium trisilicate

Criteria

Inclusion Criteria:

• Signed informed consent

• Patients who seek medical advice in primary care for symptoms thought to be GERD-related

Exclusion Criteria:

• Clinical GERD diagnosis/treatment within last 3 month

• History of severe esophagitis (i.e. LA grade C or D)

• Previous anti-reflux surgery

• History of drug abuse

• Female patients who are pregnant or lactating or at risk of pregnancy