Trials / Completed
CompletedNCT00251927
Esomeprazole (NEXIUM) vs. Surgery
An Open, Randomized, Multicenter, Phase IIIB Study During 5 Years to Assess Long-term Efficacy and Tolerability of Esomeprazole Compared to Laparoscopic Anti-reflux Surgery in Adult Subjects With Gastroesophageal Reflux Disease - LOTUS.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 626 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | esomeprazole | 40 mg oral tablet administered daily |
| PROCEDURE | Laparoscopic fundoplication (surgery) | Surgery |
Timeline
- Start date
- 2001-10-01
- Primary completion
- 2009-04-01
- Completion
- 2009-04-01
- First posted
- 2005-11-11
- Last updated
- 2012-08-08
- Results posted
- 2012-08-08
Locations
59 sites across 12 countries: Austria, Belgium, Denmark, Finland, France, Germany, Iceland, Italy, Netherlands, Norway, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT00251927. Inclusion in this directory is not an endorsement.