Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Safety and Efficacy Study of Naltrexone SR/Bupropion SR and Placebo in Overweight and Obese Subjects Participating in an Intensive Behavior Modification Program

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Orexigen Therapeutics, Inc
ClinicalTrials.gov Identifier:
NCT00456521
First received: April 3, 2007
Last updated: November 18, 2014
Last verified: November 2014
Results First Received: October 8, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Obesity
Overweight
Interventions: Drug: Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
Drug: Placebo
Behavioral: Intensive group lifestyle modification counseling

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
NB32 Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
Placebo Placebo

Participant Flow:   Overall Study
    NB32     Placebo  
STARTED     591     202  
COMPLETED     342     118  
NOT COMPLETED     249     84  
Adverse Event                 150                 25  
Withdrawal by Subject                 43                 24  
Lost to Follow-up                 22                 17  
Lack of Efficacy                 3                 6  
Protocol Violation                 4                 0  
Pregnancy                 1                 1  
Drug non-compliance, moved, other                 26                 11  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized subjects

Reporting Groups
  Description
NB32 Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
Placebo Placebo
Total Total of all reporting groups

Baseline Measures
    NB32     Placebo     Total  
Number of Participants  
[units: participants]
  591     202     793  
Age  
[units: years]
Mean ± Standard Deviation
  45.89  ± 10.42     45.59  ± 11.35     45.82  ± 10.66  
Gender  
[units: participants]
     
Female     528     185     713  
Male     63     17     80  
Race/Ethnicity, Customized  
[units: participants]
     
White     405     149     554  
Black or African American     145     44     189  
Asian     6     2     8  
Native Hawaiian or Other Pacific Islander     1     0     1  
American Indian or Alaska Native     7     1     8  
Other     27     6     33  
Weight  
[units: kg]
Mean ± Standard Deviation
  100.16  ± 15.42     101.88  ± 14.96     100.60  ± 15.31  
BMI  
[units: kg/m^2]
Mean ± Standard Deviation
  36.34  ± 4.16     36.96  ± 4.18     36.50  ± 4.17  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Co-primary: Body Weight- Mean Percent Change   [ Time Frame: Baseline, 56 weeks ]

2.  Primary:   Co-primary: Body Weight- Proportion of Subjects With ≥5% Decrease   [ Time Frame: Baseline, 56 weeks ]

3.  Secondary:   Body Weight- Proportion of Subjects With ≥10% Decrease   [ Time Frame: Baseline, 56 weeks ]

4.  Secondary:   Change in Waist Circumference   [ Time Frame: Baseline, 56 weeks ]

5.  Secondary:   Change in Fasting Triglycerides Levels, Using Log-transformed Data   [ Time Frame: Baseline, 56 weeks ]

6.  Secondary:   Change in Fasting Insulin Levels, Using Log-transformed Data   [ Time Frame: Baseline, 56 weeks ]

7.  Secondary:   Change in Fasting HDL Cholesterol Levels   [ Time Frame: Baseline, 56 weeks ]

8.  Secondary:   Change in IWQOL-Lite Total Scores   [ Time Frame: Baseline, 56 weeks ]

9.  Secondary:   Change in HOMA-IR Levels, Using Log-transformed Data   [ Time Frame: Baseline, 56 weeks ]

10.  Secondary:   Change in High-sensitivity C Reactive Protein (Hs-CRP) Levels, Using Log-transformed Data   [ Time Frame: Baseline, 56 weeks ]

11.  Secondary:   Change in Fasting Blood Glucose Levels   [ Time Frame: Baseline, 56 weeks ]

12.  Secondary:   Change in Fasting LDL Cholesterol   [ Time Frame: Baseline, 56 weeks ]

13.  Secondary:   Change in Systolic Blood Pressure   [ Time Frame: Baseline, 56 weeks ]

14.  Secondary:   Change in Diastolic Blood Pressure   [ Time Frame: Baseline, 56 weeks ]

15.  Secondary:   Change in IDS-SR Total Scores   [ Time Frame: Baseline, 56 weeks ]

16.  Secondary:   Change in Food Craving Inventory Sweets Subscale Scores   [ Time Frame: Baseline, 56 weeks ]

17.  Secondary:   Change in Food Craving Inventory Carbohydrates Subscale Scores   [ Time Frame: Baseline, 56 weeks ]

18.  Secondary:   Change in Question 19 From 21-Item COE (Control of Eating) Questionnaire   [ Time Frame: Baseline, 56 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Vice President, Head of Global Development
Organization: Orexigen Therapeutics, Inc.
phone: (858) 875-8600
e-mail: Medinfo@Orexigen.com


Publications of Results:

Responsible Party: Orexigen Therapeutics, Inc
ClinicalTrials.gov Identifier: NCT00456521     History of Changes
Other Study ID Numbers: NB-302, COR-BMOD
Study First Received: April 3, 2007
Results First Received: October 8, 2014
Last Updated: November 18, 2014
Health Authority: United States: Food and Drug Administration