At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 20 enrolled
Drug / intervention
Duloxetinedrug
Likely dose
Duloxetine 60 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.
A Preliminary Comparison of the Effect of Roux-en-Y Bariatric Surgery on Blood Levels of Duloxetine
Neuropsychiatric Research Institute, Fargo, North Dakota·interventional·Posted Oct 2, 2009·Updated Aug 11, 2014
In Brief
A Phase 3 clinical trial evaluating Duloxetine for Bariatric Surgery. Completed, enrolled 20 participants across 1 site.
Detailed Summary
This study aims to determine the difference, if any, in the pharmacokinetics of duloxetine between patients who are nine to fifteen months post Roux-en-Y Bariatric Surgery and control subjects matched for body mass index (BMI), age and gender.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBariatric Surgery
CountriesUnited States
CollaboratorsUniversity of North Dakota, Eli Lilly and Company
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2009
First PostedOct 2009
Primary CompletionOct 2012
Study CompletionNov 2012
TodayJul 2026
First PostedOct 2, 2009
Enrollment StartSep 1, 2009
Primary CompletionOct 1, 2012
Study CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 16.8 years ago
Interventions
Duloxetinedrug
Single dose of 60 mg of duloxetine