Symptom Adapted Therapy in GERD Patients (SYMPATHY)

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Gastroesophageal Reflux Disease

Treatments: Drug: esomeprazole; Drug: Gelusil-Lac (Aluminum hydroxide gel,magnesium trisilicate)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00343161

D9612L00109

SYMPATHY

EudraCT-No. 2006-001316-76

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)