A Safety and Efficacy Study of Naltrexone SR/Bupropion SR in Obesity - Full Text View

Sponsored by:	Orexigen Therapeutics, Inc
Information provided by:	Orexigen Therapeutics, Inc
ClinicalTrials.gov Identifier:	NCT00567255

Purpose

The purpose of this study is to determine if a combination of two drugs leads to more weight loss than each drug alone.

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

MedlinePlus related topics: Obesity Weight Control

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), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized, Double Blind, Placebo Controlled Study Comparing the Safety and Efficacy 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 greater than or equal to 5% [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of subjects achieving a weight loss of ≥10%; Waist circumference; Fasting triglyceride,insulin, blood glucose and HDL cholesterol; HOMA-IR:IW QOL-Lite score; SF-36; IDS-SR score; hs-CRP; systolic and diastolic blood pressure [ Time Frame: 56 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1500
Study Start Date:	November 2007
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator naltrexone SR/bupropion SR	Drug: naltrexone SR/bupropion SR naltrexone SR 32 mg/bupropion SR 360 mg/day
2: Placebo Comparator Placebo	Drug: naltrexone SR/bupropion SR naltrexone SR 32 mg/bupropion SR 360 mg/day

Detailed Description:

Two Phase II clinical trials have demonstrated that the combination of naltrexone and bupropion SR is associated with greater weight loss than naltrexone alone, bupropion SR alone or placebo in subjects with uncomplicated obesity. The current study will investigate the safety and efficacy of the combination 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 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 < or = to 140 mm Hg; diastolic < or = 90 mm Hg). Anti-hypertensive medications are allowed with the exception of alpha-adrenergic 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 any opioid medication for at least 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 (ULN)
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.
TSH within normal limits or normal T3, if TSH is below normal limits
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 study participation is not allowed.
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: NCT00567255

Show 36 Study Locations

Sponsors and Collaborators

Orexigen Therapeutics, Inc

Investigators

Principal Investigator:

Frank Greenway, MD

Pennington Medical Research Center, Louisiana State University

More Information

Responsible Party:	Orexigen Therapeutics, Inc ( Eduardo Dunayevich, MD )
Study ID Numbers:	NB-303
Study First Received:	November 30, 2007
Last Updated:	April 18, 2008
ClinicalTrials.gov Identifier:	NCT00567255
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