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A Study of Two Doses of Naltrexone SR/Bupropion SR and Placebo in Obese Subjects
This study is ongoing, but not recruiting participants.
Sponsored by: Orexigen Therapeutics, Inc
Information provided by: Orexigen Therapeutics, Inc
ClinicalTrials.gov Identifier: NCT00532779
  Purpose

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.


Condition Intervention Phase
Obesity
Drug: naltrexone SR/bupropion SR
Phase III

MedlinePlus related topics: Obesity
Drug Information available for: Naltrexone Bupropion hydrochloride Bupropion Naltrexone hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Orexigen Therapeutics, Inc:

Primary Outcome Measures:
  • Co-primary outcome measures are the percentage of total body weight lost and the percentage of subjects who achieve a weight decrease of ≥ 5%. [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects achieving ≥10% weight loss; Waist circumference; Fasting triglyceride, HDL cholesterol, insulin and glucose [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 1650
Study Start Date: September 2007
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group 1: Active Comparator
Naltrexone SR 16 mg/Bupropion SR 360 mg /day
Drug: naltrexone SR/bupropion SR
naltrexone 16 mg/bupropion SR 360 mg/day naltrexone 32 mg/bupropion SR 360 mg/day
Group 2: Active Comparator
Naltrexone SR 32 mg/Bupropion SR 360 mg /day
Drug: naltrexone SR/bupropion SR
naltrexone 16 mg/bupropion SR 360 mg/day naltrexone 32 mg/bupropion SR 360 mg/day
Group 3: Placebo Comparator
Placebo
Drug: naltrexone SR/bupropion SR
naltrexone 16 mg/bupropion SR 360 mg/day naltrexone 32 mg/bupropion SR 360 mg/day

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00532779

  Show 34 Study Locations
Sponsors and Collaborators
Orexigen Therapeutics, Inc
Investigators
Principal Investigator: Frank Greenway, MD Pennington Biomedical Research Center, Baton Rouge, Louisiana
  More Information

Responsible Party: Orexigen Therapeutics, Inc ( Eduardo Dunayevich, MD )
Study ID Numbers: NB-301
Study First Received: September 19, 2007
Last Updated: April 18, 2008
ClinicalTrials.gov Identifier: NCT00532779  
Health Authority: United States: Food and Drug Administration

Keywords provided by Orexigen Therapeutics, Inc:
Obesity

Study placed in the following topic categories:
Body Weight
Signs and Symptoms
Obesity
Dopamine
Naltrexone
Bupropion
Nutrition Disorders
Overweight
Overnutrition

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Narcotic Antagonists
Physiological Effects of Drugs
Psychotropic Drugs
Pharmacologic Actions
Sensory System Agents
Therapeutic Uses
Dopamine Agents
Peripheral Nervous System Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 16, 2009