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

Tracking Information

First Received Date ^ICMJE

June 29, 2008

Last Updated Date

October 20, 2008

Start Date ^ICMJE

June 2008

Estimated Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00709371 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Zonisamide SR Plus Bupropion SR Combination Therapy in Subjects With Obesity

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment

Condition ^ICMJE

Obesity

Intervention ^ICMJE

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

Study Arms / Comparison Groups

Placebo Comparator: Zonisamide SR placebo plus bupropion SR placebo
Active Comparator: Zonisamide SR placebo plus bupropion SR 360 mg/day
Active Comparator: Zonisamide SR 120 mg/day plus bupropion SR placebo
Active Comparator: Zonisamide SR 360 mg/day plus bupropion SR placebo
Experimental: Zonisamide SR 120 mg/day plus bupropion SR 360 mg/day
Experimental: Zonisamide SR 360 mg/day plus bupropion SR 360 mg/day

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

600

Estimated Completion Date

June 2009

Estimated Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00709371

Responsible Party

Dr. Ronald Landbloom, Orexigen Therapeutics, Inc.

Study ID Numbers ^ICMJE

ZB-202

Study Sponsor ^ICMJE

Orexigen Therapeutics, Inc

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

Orexigen Therapeutics, Inc

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP