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NCT02005107 · ClinicalTrials.gov registry record · Phase 4
Venlafaxine PK Following Bariatric Surgery
A Phase 4 study of Sleeve Gastrectomy and Roux-en-Y Gastric Bypass, sponsored by North Dakota State University.
- Completed
- Registry status
- Phase 4
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT02005107 is a Phase 4 study of Sleeve Gastrectomy and Roux-en-Y Gastric Bypass that has completed, run by North Dakota State University. The registered enrollment target is 12 participants, below the 164-participant average among 8 other Sleeve Gastrectomy trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02005107, a Phase 4 study of Sleeve Gastrectomy and Roux-en-Y Gastric Bypass, has completed, sponsored by North Dakota State University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is being conducted to evaluate how the body absorbs and processes the immediate release (IR) and sustained release (XR) medication venlafaxine (Effexor®). Subject who are 1-3 years post gastric bypass or sleeve gastrectomy surgery will be invited to participate. Non-surgical controls will also be enrolled based on a matching criteria to post gastric bypass subjects. Participants will be asked to complete two 12-hour study days approximately 11 days apart. This study will enroll up to 30 participants.
Conditions Studied
Interventions
- DRUG Venlafaxine IR and Venlafaxine XR
Study Locations (1)
North Dakota
- Neuropsychiatric Research Institute - Fargo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2013-12 |
| Est. Completion | 2015-03 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02005107
The ClinicalTrials.gov registry entry for NCT02005107 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 164-participant average among 8 other Sleeve Gastrectomy trials with a reported enrollment target (93% lower). The listed sponsor is North Dakota State University, which has 16 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Sleeve Gastrectomy appearing as the primary indexed condition, and to 1 intervention - of which Venlafaxine IR and Venlafaxine XR is the first listed.
NCT02005107 reports 1 study location spanning 1 distinct geographic area - top geographies include North Dakota.
Frequently Asked Questions
What is clinical trial NCT02005107 about?
NCT02005107 is a clinical study titled "Venlafaxine PK Following Bariatric Surgery". This study is being conducted to evaluate how the body absorbs and processes the immediate release (IR) and sustained release (XR) medication venlafaxine (Effexor®). Subject who are 1-3 years post gastric bypass or sleeve gastrectomy surgery will be invited to participate. Non-surgical controls will...
What is the current status of trial NCT02005107?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 12 participants. The study started on 2013-12. Estimated completion is 2015-03.
What conditions does trial NCT02005107 study?
This clinical trial studies the following conditions: Sleeve Gastrectomy, Roux-en-Y Gastric Bypass.
What interventions are being tested in trial NCT02005107?
The interventions under investigation include: Venlafaxine IR and Venlafaxine XR (DRUG).
Who is sponsoring clinical trial NCT02005107?
This trial is sponsored by North Dakota State University, which has 16 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02005107 being conducted?
This trial has 1 study location across North Dakota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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