Zonisamide SR Plus Bupropion SR Combination Therapy in Subjects With Obesity
NCT ID: NCT00709371
Last Updated: 2012-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
729 participants
INTERVENTIONAL
2008-07-31
2009-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Combination tablet containing Zonisamide SR placebo plus bupropion SR placebo SR = Sustained Release
Zonisamide SR placebo/ bupropion SR placebo
2 placebo combination tablets twice daily for 16 weeks (maintenance period)
Bupropion 360
Combination tablet containing Zonisamide SR placebo plus bupropion SR 360 mg/day; SR = Sustained Release
Zonisamide SR placebo/ bupropion SR 360 mg/day
2 placebo and bupropion SR 90 mg combination tablets, twice daily for 16 weeks (maintenance period)
Zonisamide 120
Combination tablet containing Zonisamide SR 120 mg/day plus bupropion SR placebo; SR = Sustained Release
Zonisamide SR 120 mg/day/ bupropion SR placebo
2 zonisamide SR 30 mg and placebo combination tablets, twice daily for 16 weeks (maintenance period)
Zonisamide 360
Combination tablet containing Zonisamide SR 360 mg/day plus bupropion SR placebo; SR = Sustained Release
Zonisamide SR 360 mg/day/ bupropion SR placebo
2 zonisamide SR 90 mg and placebo combination tablets, twice daily for 16 weeks (maintenance period)
Zonisamide 120/Bupropion 360
Combination tablet containing Zonisamide SR 120 mg/day plus bupropion SR 360 mg/day; SR = Sustained Release
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)
Zonisamide 360/Bupropion 360
Combination tablet containing Zonisamide SR 360 mg/day plus bupropion SR 360 mg/day; SR = Sustained Release
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)
Interventions
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Zonisamide SR placebo/ bupropion SR placebo
2 placebo combination tablets twice daily for 16 weeks (maintenance period)
Zonisamide SR placebo/ bupropion SR 360 mg/day
2 placebo and bupropion SR 90 mg combination tablets, twice daily for 16 weeks (maintenance period)
Zonisamide SR 120 mg/day/ bupropion SR placebo
2 zonisamide SR 30 mg and placebo combination tablets, twice daily for 16 weeks (maintenance period)
Zonisamide SR 360 mg/day/ bupropion SR placebo
2 zonisamide SR 90 mg and placebo combination tablets, twice daily for 16 weeks (maintenance period)
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)
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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Orexigen Therapeutics, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Matthew Acampora, MD
Role: PRINCIPAL_INVESTIGATOR
Internal Medicine Associates of Charlotte
Caroline Apovian, MD
Role: PRINCIPAL_INVESTIGATOR
Nutrition and Weight Management Center
James Bergthold, MD
Role: PRINCIPAL_INVESTIGATOR
Summit Research Network (Oregon), Inc.
Joseph Cleaver, MD
Role: PRINCIPAL_INVESTIGATOR
The Cooper Institute
Adnan Dahdul, MD
Role: PRINCIPAL_INVESTIGATOR
FutureCare Studies
Ken Fujioka, MD
Role: PRINCIPAL_INVESTIGATOR
Nutrition and Metabolic Research
Jeffrey Geohas, MD
Role: PRINCIPAL_INVESTIGATOR
Radiant Research, Chicago
Mark Graves, MD
Role: PRINCIPAL_INVESTIGATOR
Welborn Clinic
Alok Gupta, MD
Role: PRINCIPAL_INVESTIGATOR
Pennington Biomedical Research Center
Wayne Harper, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Research Associates, LLC
Jonathan Henry, MD
Role: PRINCIPAL_INVESTIGATOR
Summit Research Network (Michigan), Inc.
Diane Krieger, MD
Role: PRINCIPAL_INVESTIGATOR
Miami Research Associates
Michael Levy, MD
Role: PRINCIPAL_INVESTIGATOR
Behavioral Medical Research
Raymond Plodkowski, MD
Role: PRINCIPAL_INVESTIGATOR
Center for Nutrition and Metabolic Disorders, University of Nevada School of Medicine
Domenica Rubino, MD
Role: PRINCIPAL_INVESTIGATOR
Washington Center for Weight Management and Research
Stan Self, MD
Role: PRINCIPAL_INVESTIGATOR
SelfCenter, PC
Diane Smith, MD
Role: PRINCIPAL_INVESTIGATOR
CSRA Partners in Health, Inc.
Timothy Smith, MD
Role: PRINCIPAL_INVESTIGATOR
Mercy Research
Claire Waltman, MD
Role: PRINCIPAL_INVESTIGATOR
Summit Research Network (Seattle), LLC
Holly Wyatt, MD
Role: PRINCIPAL_INVESTIGATOR
Center for Human Nutrition/UCD
Locations
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SelfCenter, PC
Fairhope, Alabama, United States
Nutrition and Metabolic Research
La Jolla, California, United States
Center for Human Nutrition/UCD
Denver, Colorado, United States
Miami Research Associates
Miami, Florida, United States
CSRA Partners in Health, Inc.
Augusta, Georgia, United States
Radiant Research, Chicago
Chicago, Illinois, United States
Welborn Clinic
Evansville, Indiana, United States
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
Nutrition and Weight Management Center, Boston Medical Center
Boston, Massachusetts, United States
FutureCare Studies
Springfield, Massachusetts, United States
Summit Research Network (Michigan), Inc.
Farmington Hills, Michigan, United States
Mercy Health Research
St Louis, Missouri, United States
Center for Nutrition and Metabolic Disorders, University of Nevada School of Medicine
Reno, Nevada, United States
Behavioral Medical Research
Staten Island, New York, United States
Internal Medicine Associates of Charlotte
Charlotte, North Carolina, United States
Wake Research Associates, LLC
Raleigh, North Carolina, United States
Summit Research Network (Oregon), Inc.
Portland, Oregon, United States
The Cooper Institute
Dallas, Texas, United States
Washington Center for Weight Management and Research
Arlington, Virginia, United States
Summit Research Network (Seattle), LLC.
Seattle, Washington, United States
Countries
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Other Identifiers
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ZB-202
Identifier Type: -
Identifier Source: org_study_id