Zonisamide SR Plus Bupropion SR Combination Therapy in Subjects With Obesity

November 27, 2012 updated by: Orexigen Therapeutics, Inc

A Phase IIB, Multi-Center, Dose-Parallel, Randomized, Double-Blind, Monotherapy and Placebo-Controlled Safety and Efficacy Study of Zonisamide SR Plus Bupropion SR Combination Therapy in Subjects With Obesity

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

729

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alabama
      • Fairhope, Alabama, United States, 36532
        • SelfCenter, PC
    • California
      • La Jolla, California, United States, 92037
        • Nutrition and Metabolic Research
    • Colorado
      • Denver, Colorado, United States, 80220
        • Center for Human Nutrition/UCD
    • Florida
      • Miami, Florida, United States, 33143
        • Miami Research Associates
    • Georgia
      • Augusta, Georgia, United States, 30909
        • CSRA Partners in Health, Inc.
    • Illinois
      • Chicago, Illinois, United States, 60610
        • Radiant Research, Chicago
    • Indiana
      • Evansville, Indiana, United States, 47713
        • Welborn Clinic
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Nutrition and Weight Management Center, Boston Medical Center
      • Springfield, Massachusetts, United States, 01103
        • FutureCare Studies
    • Michigan
      • Farmington Hills, Michigan, United States, 48336
        • Summit Research Network (Michigan), Inc.
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • Mercy Health Research
    • Nevada
      • Reno, Nevada, United States, 89557
        • Center for Nutrition and Metabolic Disorders, University of Nevada School of Medicine
    • New York
      • Staten Island, New York, United States, 10305
        • Behavioral Medical Research
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • Internal Medicine Associates of Charlotte
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates, LLC
    • Oregon
      • Portland, Oregon, United States, 97210
        • Summit Research Network (Oregon), Inc.
    • Texas
      • Dallas, Texas, United States, 75230
        • The Cooper Institute
    • Virginia
      • Arlington, Virginia, United States, 22201
        • Washington Center for Weight Management and Research
    • Washington
      • Seattle, Washington, United States, 98104
        • Summit Research Network (Seattle), LLC.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Female or male subjects, 18 to 65 years of age
  • Have body mass index (BMI) ≥ 30 kg/m2 and ≤ 45 kg/m2 for subjects with uncomplicated obesity, and BMI of ≥ 27 kg/m2 and ≤ 45 kg/m2 for subjects with obesity and dyslipidemia and/or controlled hypertension
  • Non-smoker and no use of tobacco or nicotine products for at least 6 months prior to screening
  • Normotensive (systolic ≤140 mm Hg; diastolic ≤90 mm Hg). Anti-hypertensive medications are allowed with the exception of adrenergic blockers and clonidine. Medical regimen must be stable for at least 6 weeks prior to randomization
  • Triglycerides <400 mg/dL. Medications for treatment of dyslipidemia are allowed with the exception of cholestyramine and cholestypol as long as medical regimen has been stable for at least 6 weeks prior to randomization
  • No clinically significant laboratory abnormalities
  • Negative urine drug screen
  • Negative serum pregnancy test in women of child-bearing potential
  • Women of child-bearing potential must be non-lactating, and agree to use acceptable contraception throughout the study period and for 30 days after discontinuation of study drug
  • Able to comply with all required study procedures and schedule
  • Able to speak and read English
  • Willing and able to give written informed consent

Exclusion Criteria:

  • Obesity of known endocrine or genetic origin (e.g., untreated hypothyroidism, Cushing's syndrome, polycystic ovary syndrome)
  • Serious medical condition
  • History of malignancy within the previous 5 years, with exception of non-melanoma skin cancer or surgically cured cervical cancer.
  • History of suicide attempt or serious psychiatric illness
  • History of Major Depressive Disorder within the past 2 years
  • In need of medications for the treatment of a psychiatric disorder (with the exception of short-term insomnia) within the previous 6 months prior to randomization
  • Type I or Type II diabetes
  • History of alcohol or drug abuse or dependence as determined by the Investigator within 1 year prior to randomization
  • History of surgical or device (e.g. gastric banding) intervention for obesity
  • History of seizures or predisposition to seizures
  • History of hypersensitivity to sulfonamides ("sulfa"), bupropion, or zonisamide
  • History of treatment with bupropion SR (Wellbutrin, Zyban) or zonisamide (Zonegran) within previous 12 months
  • History of nephrolithiasis (renal calculi)
  • Loss or gain of more than 4.0 kg within 3 months prior to randomization
  • Women of child bearing potential not adhering to a medically acceptable form of contraception
  • Pregnant or breast-feeding women or planning to become pregnant during the study period or within 30 days of discontinuing study drug

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Combination tablet containing Zonisamide SR placebo plus bupropion SR placebo SR = Sustained Release
2 placebo combination tablets twice daily for 16 weeks (maintenance period)
Active Comparator: Bupropion 360
Combination tablet containing Zonisamide SR placebo plus bupropion SR 360 mg/day; SR = Sustained Release
2 placebo and bupropion SR 90 mg combination tablets, twice daily for 16 weeks (maintenance period)
Active Comparator: Zonisamide 120
Combination tablet containing Zonisamide SR 120 mg/day plus bupropion SR placebo; SR = Sustained Release
2 zonisamide SR 30 mg and placebo combination tablets, twice daily for 16 weeks (maintenance period)
Active Comparator: Zonisamide 360
Combination tablet containing Zonisamide SR 360 mg/day plus bupropion SR placebo; SR = Sustained Release
2 zonisamide SR 90 mg and placebo combination tablets, twice daily for 16 weeks (maintenance period)
Experimental: Zonisamide 120/Bupropion 360
Combination tablet containing Zonisamide SR 120 mg/day plus bupropion SR 360 mg/day; SR = Sustained Release
2 zonisamide SR 30 mg and bupropion SR 90 mg combination tablets, twice daily for 16 weeks (maintenance period)
Experimental: Zonisamide 360/Bupropion 360
Combination tablet containing Zonisamide SR 360 mg/day plus bupropion SR 360 mg/day; SR = Sustained Release
2 zonisamide SR 90 mg and bupropion SR 90 mg combination tablets, twice daily for 16 weeks (maintenance period)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage change in total body weight
Time Frame: from baseline to 24 weeks
from baseline to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Matthew Acampora, MD, Internal Medicine Associates of Charlotte
  • Principal Investigator: Caroline Apovian, MD, Nutrition and Weight Management Center
  • Principal Investigator: James Bergthold, MD, Summit Research Network (Oregon), Inc.
  • Principal Investigator: Joseph Cleaver, MD, The Cooper Institute
  • Principal Investigator: Adnan Dahdul, MD, FutureCare Studies
  • Principal Investigator: Ken Fujioka, MD, Nutrition and Metabolic Research
  • Principal Investigator: Jeffrey Geohas, MD, Radiant Research, Chicago
  • Principal Investigator: Mark Graves, MD, Welborn Clinic
  • Principal Investigator: Alok Gupta, MD, Pennington Biomedical Research Center
  • Principal Investigator: Wayne Harper, MD, Wake Research Associates, LLC
  • Principal Investigator: Jonathan Henry, MD, Summit Research Network (Michigan), Inc.
  • Principal Investigator: Diane Krieger, MD, Miami Research Associates
  • Principal Investigator: Michael Levy, MD, Behavioral Medical Research
  • Principal Investigator: Raymond Plodkowski, MD, Center for Nutrition and Metabolic Disorders, University of Nevada School of Medicine
  • Principal Investigator: Domenica Rubino, MD, Washington Center for Weight Management and Research
  • Principal Investigator: Stan Self, MD, SelfCenter, PC
  • Principal Investigator: Diane Smith, MD, CSRA Partners in Health, Inc.
  • Principal Investigator: Timothy Smith, MD, Mercy Research
  • Principal Investigator: Claire Waltman, MD, Summit Research Network (Seattle), LLC
  • Principal Investigator: Holly Wyatt, MD, Center for Human Nutrition/UCD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

June 29, 2008

First Submitted That Met QC Criteria

June 29, 2008

First Posted (Estimate)

July 3, 2008

Study Record Updates

Last Update Posted (Estimate)

November 29, 2012

Last Update Submitted That Met QC Criteria

November 27, 2012

Last Verified

November 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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