Zonisamide SR Plus Bupropion SR Combination Therapy in Subjects With Obesity

NCT00709371 | Completed Phase 2

• 1 other identifier: ZB-202
• Study Type: interventional
• Target: 729
• Locations: 1 country
• Sites: 20

Brief 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

Keywords

obesity; zonisamide; bupropion

Outcome Measures

Primary Outcomes (1)

• Percentage change in total body weight

  from baseline to 24 weeks

Study Arms (6)

Placebo

PLACEBO COMPARATOR

Combination tablet containing Zonisamide SR placebo plus bupropion SR placebo SR = Sustained Release

Drug: Zonisamide SR placebo/ bupropion SR placebo

Bupropion 360

ACTIVE COMPARATOR

Combination tablet containing Zonisamide SR placebo plus bupropion SR 360 mg/day; SR = Sustained Release

Drug: Zonisamide SR placebo/ bupropion SR 360 mg/day

Zonisamide 120

ACTIVE COMPARATOR

Combination tablet containing Zonisamide SR 120 mg/day plus bupropion SR placebo; SR = Sustained Release

Drug: Zonisamide SR 120 mg/day/ bupropion SR placebo

Zonisamide 360

ACTIVE COMPARATOR

Combination tablet containing Zonisamide SR 360 mg/day plus bupropion SR placebo; SR = Sustained Release

Drug: Zonisamide SR 360 mg/day/ bupropion SR placebo

Zonisamide 120/Bupropion 360

EXPERIMENTAL

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

Zonisamide 360/Bupropion 360

EXPERIMENTAL

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

Interventions

Zonisamide SR placebo/ bupropion SR placebo DRUG

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

Placebo

Zonisamide SR placebo/ bupropion SR 360 mg/day DRUG

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

Bupropion 360

Zonisamide SR 120 mg/day/ bupropion SR placebo DRUG

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

Zonisamide 120

Zonisamide SR 360 mg/day/ bupropion SR placebo DRUG

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

Zonisamide 360

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

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

Zonisamide 120/Bupropion 360

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

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

Zonisamide 360/Bupropion 360

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Orexigen Therapeutics, Inc: lead

Study Sites (20)

SelfCenter, PC

Fairhope, Alabama, 36532, United States

Location

Nutrition and Metabolic Research

La Jolla, California, 92037, United States

Location

Center for Human Nutrition/UCD

Denver, Colorado, 80220, United States

Location

Miami Research Associates

Miami, Florida, 33143, United States

Location

CSRA Partners in Health, Inc.

Augusta, Georgia, 30909, United States

Location

Radiant Research, Chicago

Chicago, Illinois, 60610, United States

Location

Welborn Clinic

Evansville, Indiana, 47713, United States

Location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Nutrition and Weight Management Center, Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

FutureCare Studies

Springfield, Massachusetts, 01103, United States

Location

Summit Research Network (Michigan), Inc.

Farmington Hills, Michigan, 48336, United States

Location

Mercy Health Research

St Louis, Missouri, 63141, United States

Location

Center for Nutrition and Metabolic Disorders, University of Nevada School of Medicine

Reno, Nevada, 89557, United States

Location

Behavioral Medical Research

Staten Island, New York, 10305, United States

Location

Internal Medicine Associates of Charlotte

Charlotte, North Carolina, 28277, United States

Location

Wake Research Associates, LLC

Raleigh, North Carolina, 27612, United States

Location

Summit Research Network (Oregon), Inc.

Portland, Oregon, 97210, United States

Location

The Cooper Institute

Dallas, Texas, 75230, United States

Location

Washington Center for Weight Management and Research

Arlington, Virginia, 22201, United States

Location

Summit Research Network (Seattle), LLC.

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2008
• First Posted: July 3, 2008
• Study Start: July 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: July 1, 2009
• Last Updated: November 29, 2012

Record last verified: 2012-11

Locations

US (20)