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A Safety and Efficacy Study of Naltrexone SR/Bupropion SR in Overweight and Obese Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00567255
First Posted: December 4, 2007
Last Update Posted: November 21, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Orexigen Therapeutics, Inc
Results First Submitted: October 8, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Obesity
Overweight
Interventions: Drug: Naltrexone SR 32 mg/bupropion SR 360 mg/day
Drug: Placebo
Behavioral: Ancillary therapy

  Participant Flow
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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   1001   495 
COMPLETED   538   267 
NOT COMPLETED   463   228 
Adverse Event                241                68 
Lost to Follow-up                77                48 
Withdrawal by Subject                75                56 
Lack of Efficacy                19                33 
Protocol Violation                20                8 
Pregnancy                6                0 
Drug noncompliance,moved,other                25                15 



  Baseline Characteristics
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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 
Overall Participants Analyzed 
[Units: Participants]
 1001   495   1496 
Age 
[Units: Years]
Mean (Standard Deviation)
 44.27  (11.16)   44.41  (11.38)   44.32  (11.23) 
Gender 
[Units: Participants]
     
Female   847   420   1267 
Male   154   75   229 
Race/Ethnicity, Customized 
[Units: Participants]
     
White   835   414   1249 
Black or African American   133   72   205 
Asian   12   4   16 
Native Hawaiian or Other Pacific Islander   3   1   4 
American Indian or Alaska Native   10   2   12 
Other   8   2   10 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 100.3  (16.55)   99.21  (15.86)   99.95  (16.33) 
BMI 
[Units: Kg/m^2]
Mean (Standard Deviation)
 36.22  (4.45)   36.09  (4.27)   36.17  (4.39) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Co-primary: Body Weight- Mean Percent Change From Baseline to Week 28   [ Time Frame: Baseline, 28 weeks ]

2.  Primary:   Co-primary: Body Weight- Proportion of Subjects With ≥5% Decrease From Baseline to Week 28   [ Time Frame: Baseline, 28 weeks ]

3.  Secondary:   Body Weight- Mean Percent Change From Baseline to Week 56   [ Time Frame: Baseline, 56 weeks ]

4.  Secondary:   Body Weight- Proportion of Subjects With ≥5% Decrease From Baseline to Week 56   [ Time Frame: Baseline, 56 weeks ]

5.  Secondary:   Body Weight- Proportion of Subjects With ≥10% Decrease From Baseline to Week 28   [ Time Frame: Baseline, 28 weeks ]

6.  Secondary:   Change in Waist Circumference   [ Time Frame: Baseline, 28 weeks ]

7.  Secondary:   Change in Fasting HDL Cholesterol Levels   [ Time Frame: Baseline, 28 weeks ]

8.  Secondary:   Change in Fasting Triglycerides Levels, Using Log-transformed Data   [ Time Frame: Baseline, 28 weeks ]

9.  Secondary:   Change in IWQOL-Lite Total Scores   [ Time Frame: Baseline, 28 weeks ]

10.  Secondary:   Change in High-sensitivity C Reactive Protein (Hs-CRP) Levels, Using Log-transformed Data   [ Time Frame: Baseline, 28 weeks ]

11.  Secondary:   Change in Fasting Insulin Levels, Using Log-transformed Data   [ Time Frame: Baseline, 28 weeks ]

12.  Secondary:   Change in Fasting Blood Glucose Levels   [ Time Frame: Baseline, 28 weeks ]

13.  Secondary:   Change in HOMA-IR Levels, Using Log-transformed Data   [ Time Frame: Baseline, 28 weeks ]

14.  Secondary:   Change in Question 19 From 21-Item COE (Control of Eating) Questionnaire   [ Time Frame: Baseline, 28 weeks ]

15.  Secondary:   Change in Fasting LDL Cholesterol Levels   [ Time Frame: Baseline, 28 weeks ]

16.  Secondary:   Change in Systolic Blood Pressure   [ Time Frame: Baseline, 28 weeks ]

17.  Secondary:   Change in Diastolic Blood Pressure   [ Time Frame: Baseline, 28 weeks ]

18.  Secondary:   Change in IDS-SR Total Score   [ Time Frame: Baseline, 28 weeks ]

19.  Secondary:   Change in Food Craving Inventory Sweets Subscale Score   [ Time Frame: Baseline, 28 weeks ]

20.  Secondary:   Change in Food Craving Inventory Carbohydrates Subscale Score   [ Time Frame: Baseline, 28 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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: NCT00567255     History of Changes
Other Study ID Numbers: NB-303
COR-II ( Other Identifier: Orexigen Therapeutics, Inc. )
First Submitted: November 30, 2007
First Posted: December 4, 2007
Results First Submitted: October 8, 2014
Results First Posted: November 21, 2014
Last Update Posted: November 21, 2014