A Comparison of Immediate and Extended Release Venlafaxine Following Bariatric Surgery (VLX)

NCT02005107 Phase 4 COMPLETED

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.

Details

Lead sponsor	North Dakota State University
Phase	Phase 4
Status	COMPLETED
Enrolment	12
Start date	2013-12
Completion	2015-03

Conditions

• Roux en Y Gastric Bypass
• Sleeve Gastrectomy

Interventions

• Venlafaxine IR and Venlafaxine XR

Primary outcomes

• Venlafaxine Plasma Concentrations/Area-Under-the-Curve (AUC) — 24 hours intervals
  The primary aim of this research is to provide a comparison of pharmacokinetic measures associated with a single dose of venlafaxine IR (immediate release) and venlafaxine XR (sustained release) in Roux-en-Y Gastric Bypass, Sleeve Gastrectomy, and matched nonsurgical "control" subjects. Comparisons will be based upon venlafaxine plasma concentrations obtained during the 24 hour sample collection window.

Countries

United States