Zonisamide SR Plus Bupropion SR Combination Therapy in Subjects With Obesity

Summary

The purpose of this study is determine if the combination of zonisamide SR and bupropion SR are is more effective than either drug given alone or placebo in the treatment of obesity.

Conditions

• Obesity

Interventions

DRUG

Zonisamide SR placebo/ bupropion SR placebo

2 placebo combination tablets twice daily for 16 weeks (maintenance period)

DRUG

Zonisamide SR placebo/ bupropion SR 360 mg/day

2 placebo and bupropion SR 90 mg combination tablets, twice daily for 16 weeks (maintenance period)

DRUG

Zonisamide SR 120 mg/day/ bupropion SR placebo

2 zonisamide SR 30 mg and placebo combination tablets, twice daily for 16 weeks (maintenance period)

DRUG

Zonisamide SR 360 mg/day/ bupropion SR placebo

2 zonisamide SR 90 mg and placebo combination tablets, twice daily for 16 weeks (maintenance period)

DRUG

Zonisamide SR 120 mg/day/ bupropion SR 360 mg/day

2 zonisamide SR 30 mg and bupropion SR 90 mg combination tablets, twice daily for 16 weeks (maintenance period)

DRUG

Zonisamide SR 360 mg/day/ bupropion SR 360 mg/day

2 zonisamide SR 90 mg and bupropion SR 90 mg combination tablets, twice daily for 16 weeks (maintenance period)

Sponsors & Collaborators

• Orexigen Therapeutics, Inc

  lead INDUSTRY

Principal Investigators

• Matthew Acampora, MD · Internal Medicine Associates of Charlotte

• Caroline Apovian, MD · Nutrition and Weight Management Center

• James Bergthold, MD · Summit Research Network (Oregon), Inc.

• Joseph Cleaver, MD · The Cooper Institute

• Adnan Dahdul, MD · FutureCare Studies

• Ken Fujioka, MD · Nutrition and Metabolic Research

• Jeffrey Geohas, MD · Radiant Research, Chicago

• Mark Graves, MD · Welborn Clinic

• Alok Gupta, MD · Pennington Biomedical Research Center

• Wayne Harper, MD · Wake Research Associates, LLC

• Jonathan Henry, MD · Summit Research Network (Michigan), Inc.

• Diane Krieger, MD · Miami Research Associates

• Michael Levy, MD · Behavioral Medical Research

• Raymond Plodkowski, MD · Center for Nutrition and Metabolic Disorders, University of Nevada School of Medicine

• Domenica Rubino, MD · Washington Center for Weight Management and Research

• Stan Self, MD · SelfCenter, PC

• Diane Smith, MD · CSRA Partners in Health, Inc.

• Timothy Smith, MD · Mercy Research

• Claire Waltman, MD · Summit Research Network (Seattle), LLC

• Holly Wyatt, MD · Center for Human Nutrition/UCD

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-07-31

Primary Completion

2009-04-30

Completion

2009-07-31

Countries

• United States

Study Locations