Clinical trial NCT00709371: Zonisamide SR Plus Bupropion SR Combination Therapy in Subjects With Obesity
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Keywords: obesity
zonisamide
bupropion
Lead sponsor: Orexigen Therapeutics, Inc
Sponsor class: INDUSTRY
First posted: 2008-07-03
Enrollment: 729
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Percentage change in total body weight
timeFrame: from baseline to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Fairhope
country: United States
facility: SelfCenter, PC
state: Alabama
city: La Jolla
country: United States
facility: Nutrition and Metabolic Research
state: California
city: Denver
country: United States
facility: Center for Human Nutrition/UCD
state: Colorado
city: Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Augusta
country: United States
facility: CSRA Partners in Health, Inc.
state: Georgia
city: Chicago
country: United States
facility: Radiant Research, Chicago
state: Illinois
city: Evansville
country: United States
facility: Welborn Clinic
state: Indiana
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
city: Boston
country: United States
facility: Nutrition and Weight Management Center, Boston Medical Center
state: Massachusetts
city: Springfield
country: United States
facility: FutureCare Studies
state: Massachusetts
city: Farmington Hills
country: United States
facility: Summit Research Network (Michigan), Inc.
state: Michigan
city: St. Louis
country: United States
facility: Mercy Health Research
state: Missouri
city: Reno
country: United States
facility: Center for Nutrition and Metabolic Disorders, University of Nevada School of Medicine
state: Nevada
city: Staten Island
country: United States
facility: Behavioral Medical Research
state: New York
city: Charlotte
country: United States
facility: Internal Medicine Associates of Charlotte
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Portland
country: United States
facility: Summit Research Network (Oregon), Inc.
state: Oregon
city: Dallas
country: United States
facility: The Cooper Institute
state: Texas
city: Arlington
country: United States
facility: Washington Center for Weight Management and Research
state: Virginia
city: Seattle
country: United States
facility: Summit Research Network (Seattle), LLC.
state: Washington
Study officials:
affiliation: Internal Medicine Associates of Charlotte
name: Matthew Acampora, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nutrition and Weight Management Center
name: Caroline Apovian, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Summit Research Network (Oregon), Inc.
name: James Bergthold, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cooper Institute
name: Joseph Cleaver, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: FutureCare Studies
name: Adnan Dahdul, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nutrition and Metabolic Research
name: Ken Fujioka, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radiant Research, Chicago
name: Jeffrey Geohas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Welborn Clinic
name: Mark Graves, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pennington Biomedical Research Center
name: Alok Gupta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wake Research Associates, LLC
name: Wayne Harper, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Summit Research Network (Michigan), Inc.
name: Jonathan Henry, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Miami Research Associates
name: Diane Krieger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Behavioral Medical Research
name: Michael Levy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Nutrition and Metabolic Disorders, University of Nevada School of Medicine
name: Raymond Plodkowski, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington Center for Weight Management and Research
name: Domenica Rubino, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: SelfCenter, PC
name: Stan Self, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CSRA Partners in Health, Inc.
name: Diane Smith, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mercy Research
name: Timothy Smith, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Summit Research Network (Seattle), LLC
name: Claire Waltman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Human Nutrition/UCD
name: Holly Wyatt, MD
role: PRINCIPAL_INVESTIGATOR
References: