Nexium (Esomeprazole) in Symptom Adapted Therapy in GERD Patients (MAESTRO)

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: GERD

Treatments: Drug: Xolaam®; Drug: esomeprazole (Nexium®)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00444275

D9612L00111

EudraCT No: 2006-002867-19

Details and patient eligibility

About

To compare the efficacy of three different long-term treatment strategies of reflux disease in primary care setting.

Enrollment: 3,029 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects who seek medical advice in primary care for symptoms thought to be GERD related (GERD is a condition which develops when the reflux of stomach content causes troublesome symptoms and / or complications).

Exclusion criteria

• Subjects with any clinical GERD treatment (PPI, H2-receptor antagonists) within the last 3 months prior to Visit 1.
• A history of severe esophagitis or known other complications, with alarm symptoms

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,029 participants in 5 patient groups

Esomeprazole 20 mg Once Daily (initial phase)

Experimental group

Treatment:

Drug: esomeprazole (Nexium®)

Esomeprazole 40 mg Once Daily (initial phase)

Experimental group

Treatment:

Drug: esomeprazole (Nexium®)

Esomeprazole 20 mg Once Daily (Maintenance Phase)

Experimental group

Treatment:

Drug: esomeprazole (Nexium®)

Esomeprazole 20 mg on Demand (Maintenance Phase)

Experimental group

Treatment:

Drug: esomeprazole (Nexium®)

Antacid Treatment (Maintenance Phase)

Experimental group

Treatment:

Drug: Xolaam®