NCT00343161

Symptom Adapted Therapy in GERD Patients

A Randomized, Open, Parallel-group, Multi-national, Multi-centre, Phase IV Study to Evaluate the Efficacy of Three Different Patient Management Strategies With and Without Esomeprazole 20 mg During a 3 Months Maintenance Phase Following an Initial 4-weeks Acute Treatment Phase in Subjects With Symptoms Thought to be GERD Related

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 441 (planned)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastroesophageal Reflux Disease

Interventions

Type	Name	Description
DRUG	esomeprazole
DRUG	Gelusil-Lac (Aluminum hydroxide gel,magnesium trisilicate)

Timeline

• Start date: 2006-08-01
• Primary completion: 2007-08-01
• Completion: 2007-08-01
• First posted: 2006-06-22
• Last updated: 2011-01-24

Locations

96 sites across 1 country: Germany