NCT02616315

Efficacy of Naltrexone HCl/Bupropion HCl Extended Release Versus Placebo for Treatment of Weight Regain in Participants Post Bariatric Surgery

A Randomized, Double-Blind, Phase 4 Study to Evaluate the Efficacy of Naltrexone HCl/Bupropion HCl Extended Release Versus Placebo for Treatment of Weight Regain in Patients Post Bariatric Surgery

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the effect of naltrexone hydrochloride(HCL) and bupropion hydrochloride extended release combination (NB) compared with placebo on weight loss in obese participants post bariatric surgery.

Detailed description

The drug being tested in this study is called naltrexone hydrochloride/bupropion hydrochloride (NB). NB is being tested to determine its effect on weight loss in obese participants post bariatric surgery. The study will enroll approximately 60 participants. Participants will be randomly assigned to one of the two treatment groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need): * Naltrexone HCl 32 mg/bupropion HCl 360 mg extended-release tablet * Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient All participants will start on 1 tablet a day and will increase their dose by 1 tablet per week for 4 weeks to reach the optimal dose. This multi-center trial will be conducted in the United States. The overall time to participate in this study is 59 weeks maximum. Participants will make multiple visits to the clinic, plus a final visit 4 weeks after last dose of study drug for a follow-up assessment.

Conditions

• Weight Regain Post Bariatric Surgery

Interventions

Type	Name	Description
DRUG	Naltrexone HCl/Bupropion HCl Placebo	Naltrexone/bupropion placebo-matching tablets
DRUG	Naltrexone HCl/Bupropion HCl	Naltrexone HCl 8 mg/bupropion HCl 90 mg tablets

Timeline

• Start date: 2016-02-01
• Primary completion: 2017-10-01
• Completion: 2017-12-01
• First posted: 2015-11-26
• Last updated: 2016-04-08

Locations

2 sites across 1 country: United States