Zonisamide SR Plus Bupropion SR Combination Therapy in Subjects With Obesity - Full Text View

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 plus bupropion SR placebo Drug: Zonisamide SR placebo plus bupropion SR 360 mg/day Drug: Zonisamide SR 120 mg/day plus bupropion SR placebo Drug: Zonisamide SR 360 mg/day plus bupropion SR placebo Drug: Zonisamide SR 120 mg/day plus bupropion SR 360 mg/day Drug: Zonisamide SR 360 mg/day plus bupropion SR 360 mg/day	Phase II

MedlinePlus related topics:

Obesity

Drug Information available for:

Bupropion hydrochloride Bupropion Zonisamide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment

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 Uncomplicated Obesity

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 ]

Estimated Enrollment:	600
Study Start Date:	June 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Zonisamide SR placebo plus bupropion SR placebo	Drug: Zonisamide SR placebo plus bupropion SR placebo 2 placebo tablets twice daily for 16 weeks (maintenance period)
2: Active Comparator Zonisamide SR placebo plus bupropion SR 360 mg/day	Drug: Zonisamide SR placebo plus bupropion SR 360 mg/day 2 placebo and bupropion SR 90 mg tablets, twice daily for 16 weeks (maintenance period)
3: Active Comparator Zonisamide SR 120 mg/day plus bupropion SR placebo	Drug: Zonisamide SR 120 mg/day plus bupropion SR placebo 2 zonisamide SR 30 mg and placebo tablets, twice daily for 16 weeks (maintenance period)
4: Active Comparator Zonisamide SR 360 mg/day plus bupropion SR placebo	Drug: Zonisamide SR 360 mg/day plus bupropion SR placebo 2 zonisamide SR 90 mg and placebo tablets, twice daily for 16 weeks (maintenance period)
5: Experimental Zonisamide SR 120 mg/day plus bupropion SR 360 mg/day	Drug: Zonisamide SR 120 mg/day plus bupropion SR 360 mg/day 2 zonisamide SR 30 mg and bupropion SR 90 mg tablets, twice daily for 16 weeks (maintenance period)
6: Experimental Zonisamide SR 360 mg/day plus bupropion SR 360 mg/day	Drug: Zonisamide SR 360 mg/day plus bupropion SR 360 mg/day 2 zonisamide SR 90 mg and bupropion SR 90 mg 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
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)
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 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 hypersensitivity to sulfonamides ("sulfa"), bupropion, or zonisamide
History of treatment with bupropion SR (Wellbutrin, Zyban) or zonisamide (Zonegran) within previous 12 months
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

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

Responsible Party:	Orexigen Therapeutics, Inc. ( Dr. Ronald Landbloom )
Study ID Numbers:	ZB-202
First Received:	June 29, 2008
Last Updated:	October 20, 2008
ClinicalTrials.gov Identifier:	NCT00709371
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by Orexigen Therapeutics, Inc:

obesity

zonisamide

bupropion

Study placed in the following topic categories:

Body Weight

Signs and Symptoms

Obesity

Dopamine

Bupropion

Zonisamide

Nutrition Disorders

Overweight

Overnutrition

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors

Neurotransmitter Uptake Inhibitors

Neurotransmitter Agents

Antioxidants

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Psychotropic Drugs

Protective Agents

Pharmacologic Actions

Therapeutic Uses

Dopamine Agents

Antidepressive Agents, Second-Generation

Central Nervous System Agents

Anticonvulsants

Antidepressive Agents

ClinicalTrials.gov processed this record on November 04, 2008

Sponsored by:	Orexigen Therapeutics, Inc
Information provided by:	Orexigen Therapeutics, Inc
ClinicalTrials.gov Identifier:	NCT00709371