Safety and Efficacy of Different Combinations of Zonisamide-CR Plus Bupropion-SR to Treat Uncomplicated Obesity
A Dose Parallel, Randomized, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of Multiple Regimens of the Combination of Zonisamide CR Plus Bupropion SR in the Treatment of Subjects With Uncomplicated Obesity
1 other identifier
interventional
611
1 country
15
Brief Summary
The purpose of this study is to determine which of seven combinations of Zonisamide CR and Bupropion SR gives the best weight loss and is safe and well tolerated for the treatment of obesity not associated with the complications of obesity such as diabetes. In a previous study, the combination of zonisamide and bupropion SR was shown to be effective for weight loss compared to either zonisamide, bupropion SR alone or placebo. It is thought that by adjusting the doses of each drug, giving zonisamide in a controlled release (CR) form and increasing the doses more slowly, more weight loss and less side effects can be attained.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 obesity
Started May 2006
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 18, 2006
CompletedFirst Posted
Study publicly available on registry
June 20, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedApril 22, 2008
April 1, 2008
1.3 years
June 18, 2006
April 18, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
% change in total body weight as measured between baseline and week 24 (ITT-LOCF analysis)
Baseline to week 24
Secondary Outcomes (10)
Absolute change in total body weight in kg.
Baseline to week 24
Proportion of subjects achieving > 5% weight loss.
Baseline to week 24
Proportion of subjects achieving > 10% weight loss.
Baseline to week 24
Proportion of subjects achieving > 5% weight loss at week 24 who maintain response to week 48
Baseline to week 24
Change in measures of quality of life, sleep quality and sleep quantity
Baseline to week 24
- +5 more secondary outcomes
Study Arms (7)
Group 1
ACTIVE COMPARATORZonisamide SR 120 mg/day plus Bupropion SR 280 mg/day
Group 2
ACTIVE COMPARATORZonisamide SR 120 mg/day plus Bupropion SR 360 mg/day
Group 3
ACTIVE COMPARATORZonisamide SR 240 mg/day plus Bupropion SR 280 mg/day
Group 4
ACTIVE COMPARATORZonisamide SR 240 mg/day plus Bupropion SR 360 mg/day
Group 5
ACTIVE COMPARATORZonisamide SR 360 mg/day plus Bupropion SR 280 mg/day
Group 6
ACTIVE COMPARATORZonisamide SR 360 mg/day plus Bupropion SR 360 mg/day
Group 7
PLACEBO COMPARATORInterventions
Zonisamide SR and Bupropion SR
Eligibility Criteria
You may qualify if:
- Have body mass index (BMI) of 30 to 43 kg/m2
- Free from any other clinically significant illness or disease as determined by medical history and physical examination
- 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, beta-blockers and clonidine. Medical regimen must be stable for at least 6 weeks
- LDL cholesterol \< 190 mg/dL and triglycerides \< 400 mg/dL. Medications for treatment of dyslipidemia are allowed as long as medical regimen has been stable for at least 6 weeks
- Negative serum pregnancy test in women with an intact uterus
- Score \< 15 for depression and score \< 15 for anxiety on Hospital Anxiety and Depression Scale (HADS)
- No clinically significant abnormality on ECG
- Not on eExcluded concomitant medications
- If female with intact uterus, be non-lactating, and agree to use effective contraception throughout the study period and for 30 days after discontinuation of study drugs.
- Able to comply with all required study procedures and schedule
- Able to use and have access to a touch tone telephone and to speak and read English
You may not qualify if:
- Obesity of known endocrine or genetic origin
- Serious medical condition
- Serious psychiatric illness
- Active suicidal ideation; score \> 2 on the Mood Assessment questionnaire
- A response to Bipolar Disorder questions indicating the presence of Bipolar Disorder
- Type I diabetes mellitus or Type II diabetes mellitus requiring pharmacotherapy
- History of alcohol or drug abuse, current or within 5 years
- History of bulimia or anorexia nervosa
- History of surgical intervention for obesity
- History of seizure disorder or predisposition to seizures (e.g., history of cerebrovascular accident, significant head trauma, brain surgery, skull fracture, subdural hematoma, or alcohol withdrawal or febrile seizures)
- History of hypersensitivity to sulfonamides ("sulfa"), bupropion, or zonisamide
- History of nephrolithiasis (renal calculi)
- History of treatment with bupropion SR (Wellbutrin, Zyban) or zonisamide (Zonegran) within 12 months
- Use of drugs, herbs, or dietary supplements known to significantly affect body weight or participation in a weight loss management program within one month prior to baseline
- Loss or gain of more than 4.0 kilos within 3 months
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
SelfCenter, PC
Fairhope, Alabama, 36532, United States
UCLA Center for Human Nutrition
Los Angeles, California, 90095, United States
Scripps Clinic Del Mar
San Diego, California, 92130, United States
Center for Human Nutrition University of Colorado Health Sciences Center
Denver, Colorado, 80220, United States
George Washington University Weight Management Program
Washington D.C., District of Columbia, 20037, United States
CSRA Partners in Health, Inc
Augusta, Georgia, 30909, United States
Springfield Diabetes and Endocrine Center
Springfield, Illinois, 62704, United States
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808, United States
Nutrition and Weight Mangement Center Boston Medical Center
Boston, Massachusetts, 02118, United States
Center for Nutrition and Metabolic Diseases
Reno, Nevada, 89557, United States
Comprehensive Weight Control Program
New York, New York, 10021, United States
Center for Nutrition and Preventive Medicine
Charlotte, North Carolina, 28211, United States
MUSC Weight Mnagement Center
Charleston, South Carolina, 29425, United States
The Cooper Institute
Dallas, Texas, 75230, United States
Baylor Endocrine Center
Dallas, Texas, 75246, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frank Greenway, MD
Pennington Biomedical Research Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 18, 2006
First Posted
June 20, 2006
Study Start
May 1, 2006
Primary Completion
August 1, 2007
Study Completion
August 1, 2007
Last Updated
April 22, 2008
Record last verified: 2008-04