Trials / Completed
CompletedNCT01015976
A Preliminary Comparison of the Blood Levels of Medications in Obese Subjects Compared to Post-Gastric Bypass Subjects
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Neuropsychiatric Research Institute, Fargo, North Dakota · Academic / Other
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to determine the difference, if any, in the area under the sertraline plasma level time curve (AUC) 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.
Detailed description
Secondary objectives include the determination of changes in mean CPmax, Time to CPmax and Volume of Distribution between the two groups. Also, assessment of subject tolerance of sertraline utilizing the UKU side effect rating scale.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | bariatric surgery | Roux en Y bariatric surgery |
| OTHER | control | No surgery |
Timeline
- Start date
- 2009-02-01
- Primary completion
- 2010-04-01
- Completion
- 2010-04-01
- First posted
- 2009-11-18
- Last updated
- 2014-03-31
- Results posted
- 2014-03-31
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01015976. Inclusion in this directory is not an endorsement.