Zonisamide SR Plus Bupropion SR Combination Therapy in Subjects With Obesity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Orexigen Therapeutics, Inc
ClinicalTrials.gov Identifier:
NCT00709371
First received: June 29, 2008
Last updated: November 27, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Obesity
Drug: Zonisamide SR placebo/ bupropion SR placebo
Drug: Zonisamide SR placebo/ bupropion SR 360 mg/day
Drug: Zonisamide SR 120 mg/day/ bupropion SR placebo
Drug: Zonisamide SR 360 mg/day/ bupropion SR placebo
Drug: Zonisamide SR 120 mg/day/ bupropion SR 360 mg/day
Drug: Zonisamide SR 360 mg/day/ bupropion SR 360 mg/day
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Orexigen Therapeutics, Inc:

Primary Outcome Measures:
  • Percentage change in total body weight [ Time Frame: from baseline to 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 729
Study Start Date: July 2008
Study Completion Date: July 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Combination tablet containing Zonisamide SR placebo plus bupropion SR placebo SR = Sustained Release
Drug: Zonisamide SR placebo/ bupropion SR placebo
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
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)
Active Comparator: Zonisamide 120
Combination tablet containing Zonisamide SR 120 mg/day plus bupropion SR placebo; SR = Sustained Release
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)
Active Comparator: Zonisamide 360
Combination tablet containing Zonisamide SR 360 mg/day plus bupropion SR placebo; SR = Sustained Release
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)
Experimental: Zonisamide 120/Bupropion 360
Combination tablet containing Zonisamide SR 120 mg/day plus bupropion SR 360 mg/day; SR = Sustained Release
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)
Experimental: Zonisamide 360/Bupropion 360
Combination tablet containing Zonisamide SR 360 mg/day plus bupropion SR 360 mg/day; SR = Sustained Release
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)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00709371

  Show 20 Study Locations
Sponsors and Collaborators
Orexigen Therapeutics, Inc
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 Health Research
Principal Investigator: Claire Waltman, MD Summit Research Network (Seattle), LLC
Principal Investigator: Holly Wyatt, MD Center for Human Nutrition/UCD
  More Information

No publications provided

Responsible Party: Orexigen Therapeutics, Inc
ClinicalTrials.gov Identifier: NCT00709371     History of Changes
Other Study ID Numbers: ZB-202
Study First Received: June 29, 2008
Last Updated: November 27, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Orexigen Therapeutics, Inc:
obesity
zonisamide
bupropion

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Zonisamide
Bupropion
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on August 26, 2014