At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 626 enrolled
Drug / intervention
esomeprazole +1 moredrug
Likely dose
esomeprazole 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 3 clinical trial evaluating esomeprazole and Laparoscopic fundoplication (surgery) for Gastroesophageal Reflux. Completed, enrolled 626 participants across 59 sites in 12 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastroesophageal Reflux
CountriesAustria, Belgium, Denmark, Finland, France, Germany, Iceland, Italy, Netherlands, Norway, Sweden, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2001
First PostedNov 2005
Primary CompletionApr 2009
TodayJul 2026
First PostedNov 11, 2005
Enrollment StartOct 1, 2001
Primary CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 7.5 yearsPosted 20.6 years ago
Interventions
esomeprazoledrug
40 mg oral tablet administered daily
Laparoscopic fundoplication (surgery)procedure
Surgery