A Study of Naltrexone SR/Bupropion SR and Placebo in Obese Subjects Participating in a Behavior Modification Program - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

April 3, 2007

Last Updated Date

January 5, 2009

Start Date ^†

April 2007

Current Primary Outcome Measures ^†

Change in percentage of total body weight lost [ Time Frame: Baseline to week 56 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00456521 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Effect on selected obesity-associated cardiovascular risk factors, including serum triglycerides, HDL and LDL cholesterol, waist circumference, glucose and insulin levels. [ Time Frame: Baseline to week 56 ] [ Designated as safety issue: No ]
Proportion of subjects who lose at least 5% and 10% of their baseline body weight [ Time Frame: Baseline to week 56 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Proportion of subjects who lose at least 5% and 10% of their baseline body weight
Effects on mood from baseline to week 56 as measured by the IDS-SR
Effect on selected obesity-associated cardiovascular risk factors, including serum triglycerides, HDL and LDL cholesterol, waist circumference, glucose and insulin levels, HOMA-IR, hs-CRP levels and vital signs.
Effects on quality of life from baseline to week 56 as measured by the IWQOL- Lite

Descriptive Information

Brief Title ^†

A Study of Naltrexone SR/Bupropion SR and Placebo in Obese Subjects Participating in a Behavior Modification Program

Official Title ^†

A Phase 3 Study Comparing the Safety and Efficacy of Naltrexone SR/Bupropion SR and Placebo in Subjects With Obesity Participating in a Behavior Modification Program

Brief Summary

The purpose of this study is to determine whether a combination of 2 drugs is safe and effective in treating obesity and leads to greater weight loss when given with a group lifestyle modification program than with group lifestyle modification alone.

Detailed Description

The combination of group lifestyle modification counseling and pharmacotherapy has recently been shown to result in nearly twice the average weight loss at one year (12.1 kg) as pharmacotherapy alone (sibutramine, 5.0 kg) or lifestyle modification counseling alone (6.7 kg. Combining pharmacotherapy with a comprehensive program of diet, exercise and group lifestyle modification counseling may provide the best weight loss regimen. This study will evaluate weight loss in subjects participating in such a comprehensive program who receive a combination of naltrexone SR and bupropion SR or placebo.

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Obesity

Intervention ^†

Drug: naltrexone SR/bupropionSR combination
Behavioral: Group lifestyle modification counseling

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

793

Completion Date

December 2008

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Female and male subjects, 18 to 65 years of age
Have body mass index (BMI) between 30 and 45kg/m2 for subjects with uncomplicated obesity, and 27 and 45kg/m2 for subjects with obesity and controlled hypertension and/or dyslipidemia
Non-smoker and no use of tobacco or nicotine products for at least 6 months
Normotensive(< 140/90 mm Hg), some anti-hypertensive medications are allowed
LDL cholesterol < 190 mg/dL and triglycerides < 400 mg/dL
Women of child bearing potential must have negative serum pregnancy, must be non-lactating and agree to use effective contraception throughout the study period and 30 days after stopping study drug

Exclusion Criteria:

Obesity of known endocrine origin such as untreated hypothyroidism or Polycystic Ovary Syndrome
Serious medical condition
Serious psychiatric illness
Type I or Type II diabetes mellitus
Need of medications for the treatment of a psychiatric disorder (with the exception of short-term insomnia) within the previous 6 months
On prohibited concomitant medication
History of surgical or device (e.g. lap band) intervention for obesity
History of seizures or predisposition to seizures

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00456521

Responsible Party

Eduardo Dunayevich, MD, Orexigen Therapeutics, Inc

Secondary IDs ^††

Study Sponsor ^†

Orexigen Therapeutics, Inc

Collaborators ^††

Investigators ^†

Principal Investigator:

Frank Greenway, MD

Pennington Biomedical Research Center, Baton Rouge, Louisiana

Information Provided By

Orexigen Therapeutics, Inc

Verification Date

January 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.