Status:
COMPLETED
Safety and Efficacy of Different Combinations of Zonisamide-CR Plus Bupropion-SR to Treat Uncomplicated Obesity
Lead Sponsor:
Orexigen Therapeutics, Inc
Conditions:
Obesity
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
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 assoc...
Detailed Description
Over the past few years, knowledge of the pathways and neural circuits that sense body energy stores has increased dramatically. In particular, it has been shown that the melanocortin system, a group ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Women of child bearing potential not adhering to an acceptable form of contraception
- Pregnant or breast-feeding women
- Use of investigational drug, device or procedure within 30 days
- Participation in any previous clinical trial conducted by Orexigen Therapeutics
- Planned surgical procedure that can impact the conduct of the study
- Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in this study
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
611 Patients enrolled
Trial Details
Trial ID
NCT00339014
Start Date
May 1 2006
End Date
August 1 2007
Last Update
April 22 2008
Active Locations (15)
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1
SelfCenter, PC
Fairhope, Alabama, United States, 36532
2
UCLA Center for Human Nutrition
Los Angeles, California, United States, 90095
3
Scripps Clinic Del Mar
San Diego, California, United States, 92130
4
Center for Human Nutrition University of Colorado Health Sciences Center
Denver, Colorado, United States, 80220