A Study of Two Doses of Naltrexone SR/Bupropion SR and Placebo in Obese Subjects
Information source: Orexigen Therapeutics, Inc
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obesity
Intervention: naltrexone SR/bupropion SR (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Orexigen Therapeutics, Inc Official(s) and/or principal investigator(s):
Frank Greenway, MD, Principal Investigator, Affiliation: Pennington Biomedical Research Center, Baton Rouge, Louisiana
Summary
The purpose of this study is to determine whether 2 doses of the combination of naltrexone SR
and bupropion SR are safe and effective in the treatment of obesity.
Clinical Details
Official title: A Phase 3 Study Comparing the Safety and Efficacy of Two Doses of Naltrexone Sustained Release (SR)/Bupropion Sustained Release (SR) and Placebo in Obese Subjects
Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Co-primary outcome measures are the percentage of total body weight lost and the percentage of subjects who achieve a weight decrease of ≥ 5%.
Secondary outcome: Proportion of subjects achieving ≥10% weight loss; Waist circumference; Fasting triglyceride, HDL cholesterol, insulin and glucose
Detailed description:
Two Phase II clinical trials have demonstrated that a combination of bupropion SR and
naltrexone is associated with greater weight loss than bupropion SR alone, naltrexone alone,
or placebo in subjects with uncomplicated obesity. The current study will investigate the
safety and efficacy of 2 doses of the combination of naltrexone SR and bupropion SR compared
to placebo in obese subjects with uncomplicated obesity and in those with obesity and
hypertension and/or dyslipidemia.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Female and male subjects, 18 to 65 years of age
- Have body mass index (BMI)of 30 to 45kg/m2 for subjects with uncomplicated obesity,
and BMI of 27 to 45kg/m2 for subjects with obesity and controlled hypertension and/or
dyslipidemia
- Normotensive (systolic BP < or = 140 mm Hg; diastolic < or = 90 mm Hg).
Anti-hypertensive medications are allowed with the exception of alpha-adrenergic
blockers, beta-blockers and clonidine. Medical regimen must be stable for at least 6
weeks prior to randomization
- Medications for treatment of dyslipidemia are allowed as long as medical regimen has
been stable for at least 6 weeks prior to randomization
- Free of opioid medication for 7 days prior to randomization
- No clinically significant abnormality of serum albumin, blood urea nitrogen,
creatinine, bilirubin, sodium, potassium, chloride, calcium or phosphorus
- ALT and AST within 2. 5 x upper limit of normal
- No clinically significant abnormality of hematocrit, white blood cell count, white
cell differential, or platelets
- Fasting glucose < 126 mg/dL on no hypoglycemic agents, fasting triglycerides < 400
mg/dL
- Negative serum pregnancy test in women of child bearing potential
- Negative urine drug screen
- If woman of child bearing potential, must be non-lactating and agree to use effective
contraception throughout the study period and 30 days after discontinuation of study
drug
- Able to speak and read English
Exclusion Criteria:
- Serious medical condition
- History of malignancy within the previous 5 years, with exception of non-melanoma skin
cancer or surgically cured cervical cancer
- A lifetime history a serious psychiatric illness
- Current serious psychiatric illness
- 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
- History of drug or alcohol abuse or dependence (with the exception of nicotine
dependence) within 1 year prior to study participation
- Type I or Type II diabetes mellitus
- On prohibited concomitant medications
- History of surgical or device (e. g. gastric banding) intervention for obesity
- History of seizures of any etiology, or of predisposition to seizures
- History of treatment with bupropion, or naltrexone within the preceding 12 months
- History of hypersensitivity or intolerance to bupropion or naltrexone
- Use of nicotine replacement products (nicotine gum, patch etc) during this period is
excluded
- Use of drugs, herbs, or dietary supplements believed to significantly affect body
weight or participation in a weight loss management program within one month prior to
randomization
- Loss or gain of more than 4. 0 kilograms within 3 months prior to randomization
- Pregnant or breast-feeding women or planning to become pregnant during the study
period or within 30 days of discontinuing study drug
Locations and Contacts
SelfCenter, PC, Fairhope, Alabama 36532, United States
Radiant Research, Birmingham, Alabama 35209, United States
Radiant Research, Phoenix Southeast, Chandler, Arizona 85225, United States
Scripps Clinic Del mar, San Diego, California 92130, United States
Advance Clinical Research Institute, Orange, California 92869, United States
VA San Diego Healthcare System, San Diego, California 92161, United States
Advanced Clinical Research Institute, Anaheim, California 92801, United States
Miami Research Associates, Miami, Florida 33143, United States
University Clinical Research, Pembroke Pines, Florida 33024, United States
CSRA Partners in Health, Inc, Augusta, Georgia 30909, United States
Georgia Clinical Research, Atlanta, Georgia 30308, United States
East-West Medical Research Institute, Honolulu, Hawaii 96814, United States
Radiant Research, Chicago, Illinois 60610, United States
Welborn Clinic, Evansville, Indiana 47713, United States
Radiant Research Kansas City, Overland Park, Kansas 66202, United States
Central Kentucky Research Associates, Inc., Lexington, Kentucky 40509, United States
Medical Research Institute, Slidell, Louisiana 70458, United States
Pennington Biomedical Research Center, Baton Rouge, Louisiana 70808, United States
Health Trends Research, LLC, Baltimore, Maryland 21209, United States
FutureCare Studies, Springfield, Massachusetts 01103, United States
Center for Nutrition and Metabolic Diseases, Reno, Nevada 89557, United States
Center for Nutrition and Preventive Medicine, Charlotte, North Carolina 28211, United States
Wake Research Associates, LLC, Raleigh, North Carolina 27612, United States
Rapid Medical Research, Inc., Cleveland, Ohio 44122, United States
Central Ohio Nutrition Center, Inc., Columbus, Ohio 43213, United States
Lynn Health Science Institute, Oklahoma City, Oklahoma 73112, United States
Summit Research Network (Oregon), Inc., Portland, Oregon 97210, United States
Jackson Clinic, PA, Jackson, Tennessee 38305, United States
Internal Medicine Associates of Cordova, Cordova, Tennessee 38018, United States
Baylor Endocrine Center, Dallas, Texas 75246, United States
Radiant Research, San Antonio, Texas 78217, United States
Covance Clinical Research Unit Austin, Austin, Texas 78752, United States
Radiant Research, Dallas, Texas 75231, United States
North San Antonio Health Care Assoc., San Antonio, Texas 78218, United States
Additional Information
Starting date: September 2007
Ending date: April 2009
Last updated: April 18, 2008
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