NCT00444275

Nexium (Esomeprazole) in Symptom Adapted Therapy in GERD Patients

A Randomized, Open, Parallel-group Study to Evaluate the Efficacy of Three Different Patient Management Strategies During a 12 Weeks 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: 3,029 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• GERD

Interventions

Type	Name	Description
DRUG	esomeprazole (Nexium®)	This randomized study was conducted on parallel groups and included two phases: * One initial phase during when the patients received once daily, either esomeprazole 20 mg or esomeprazole 40 mg, depending on the investigator's decision * One maintenance treatment phase, patients were randomized to one of the following three groups, either esomeprazole 20 mg once daily, or esomeprazole 20 mg on demand or antacid treatment as needed
DRUG	Xolaam®	This randomized study was conducted on parallel groups and included two phases: * One initial phase during when the patients received once daily, either esomeprazole 20 mg or esomeprazole 40 mg, depending on the investigator's decision * One maintenance treatment phase, patients were randomized to one of the following three groups, either esomeprazole 20 mg once daily, or esomeprazole 20 mg on demand or antacid treatment as needed

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2007-03-07
• Last updated: 2012-12-11
• Results posted: 2012-12-11

Locations

1 site across 1 country: France