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

NCT02616315 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2016-04-08

No results posted yet for this study

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.

Conditions

  • Weight Regain Post Bariatric Surgery

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Medical Director US Medical Affairs · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2017-10-31
Completion
2017-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02616315 on ClinicalTrials.gov