Status:
COMPLETED
Esomeprazole (NEXIUM) vs. Surgery
Lead Sponsor:
AstraZeneca
Conditions:
Gastroesophageal Reflux
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The study investigates the efficacy of long-term treatment of esomeprazole compared to anti-reflux surgery in the control of gastroesophageal reflux disease by assessing time to treatment failure.
Eligibility Criteria
Inclusion
- Subjects considered suitable for surgical treatment and long-term management of esomeprazole.
- History of chronic reflux esophagitis or symptomatic GERD
Exclusion
- History of esophageal, gastric, or duodenal surgery predicted to influence negatively on subsequent treatment within the study.
- Contraindication to the study drug.
- Pregnancy, lactating or of child-bearing potential.
Key Trial Info
Start Date :
October 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
626 Patients enrolled
Trial Details
Trial ID
NCT00251927
Start Date
October 1 2001
End Date
April 1 2009
Last Update
August 8 2012
Active Locations (59)
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1
Research Site
Linz, Austria
2
Research Site
Vienna, Austria
3
Research Site
Zell am See, Austria
4
Research Site
Brussels, Belgium