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Method-of-Use Study Assessing the Effect of Naltrexone Sustained Release (SR)/ Bupropion SR on Body Weight and Cardiovascular Risk Factors in Overweight and Obese Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Orexigen Therapeutics, Inc
ClinicalTrials.gov Identifier:
NCT01764386
First received: January 4, 2013
Last updated: November 30, 2015
Last verified: November 2015
Results First Received: September 7, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Obesity
Overweight
Interventions: Drug: NB
Behavioral: CLI
Behavioral: Usual Care

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
NB + CLI

Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)

NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)

CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools.

The Controlled Treatment Period was from Day 1 to Week 26. The Uncontrolled Treatment Period was from Week 26 to Week 78. At the end of the Controlled Treatment Period (Week 26), subjects assigned to NB+CLI continued with NB+CLI for the duration of the study (Week 78).

Usual Care

Usual Care (self-directed lifestyle intervention)

Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff.

The Controlled Treatment Period was from Day 1 to Week 26. The Uncontrolled Treatment Period was from Week 26 to Week 78. At the end of the Controlled Treatment Period (Week 26), subjects assigned to Usual Care were switched to NB+CLI for the duration of the study (Week 78).


Participant Flow for 2 periods

Period 1:   Controlled Treatment Period (CTP)
    NB + CLI   Usual Care
STARTED   153   89 
COMPLETED   71 [1]   82 [1] 
NOT COMPLETED   82   7 
Adverse Event                35                0 
Wk 16 Efficacy and BP Criteria                32                0 
Lost to Follow-up                9                5 
Withdrawal of Consent,Protocol Deviation                6                2 
[1] Completed the 26-week Controlled Treatment Period.

Period 2:   Uncontrolled Treatment Period (UTP)
    NB + CLI   Usual Care
STARTED   71   81 [1] 
Completed 52 Weeks   61   35 
COMPLETED   55 [2]   28 [2] 
NOT COMPLETED   16   53 
Adverse Event                2                13 
Wk 42 Efficacy and BP Criteria                0                26 
Lost to Follow-up                9                9 
Withdrawal of Consent,Protocol Deviation                5                5 
[1] One subject completed the 26-week CTP, but did not continue in the UTP.
[2] Completed the 78-week study.



  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.
Baseline analysis was based on the Intent-to-Treat (ITT) population which comprised all subjects randomized to NB + CLI who received at least 1 dose of study medication and all subjects randomly assigned to Usual Care who received their baseline lifestyle intervention program instruction.

Reporting Groups
  Description
NB + CLI

Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)

NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)

CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools.

Usual Care

Usual Care (self-directed lifestyle intervention)

Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff.

Total Total of all reporting groups

Baseline Measures
    NB + CLI   Usual Care   Total
Overall Participants Analyzed 
[Units: Participants]
 153   89   242 
Age 
[Units: Years]
Mean (Standard Deviation)
 46.1  (9.66)   47.0  (9.98)   46.5  (9.77) 
Gender 
[Units: Participants]
     
Female   125   77   202 
Male   28   12   40 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   4   5   9 
Not Hispanic or Latino   149   84   233 
Unknown or Not Reported   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   1   1 
Asian   1   0   1 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   28   24   52 
White   124   64   188 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   153   89   242 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 101.4  (15.09)   100.2  (16.58)   100.9  (15.63) 
Baseline BMI 
[Units: Kg/m^2]
Mean (Standard Deviation)
 36.33  (4.200)   36.26  (4.369)   36.31  (4.254) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percent Change in Body Weight From Baseline (Day 1) to Week 26   [ Time Frame: Baseline to Week 26 ]

2.  Secondary:   Percentage of Subjects Achieving a Loss of at Least 5% of Baseline Body Weight at Week 26   [ Time Frame: Baseline to Week 26 ]

3.  Secondary:   Percentage of Subjects Achieving a Loss of at Least 10% of Baseline Body Weight at Week 26   [ Time Frame: Baseline to Week 26 ]

4.  Secondary:   Percentage of Subjects Achieving a Loss of at Least 15% of Baseline Body Weight at Week 26   [ Time Frame: Baseline to Week 26 ]

5.  Secondary:   Absolute Change in Body Weight From Baseline to Week 26   [ Time Frame: Baseline to Week 26 ]

6.  Secondary:   Change in Waist Circumference From Baseline to Week 26   [ Time Frame: Baseline to Week 26 ]

7.  Secondary:   Change in Fasting Triglycerides From Baseline to Week 26   [ Time Frame: Baseline to Week 26 ]

8.  Secondary:   Change in Fasting Low-density Lipoprotein Cholesterol From Baseline to Week 26   [ Time Frame: Baseline to Week 26 ]

9.  Secondary:   Change in Fasting High-density Lipoprotein Cholesterol From Baseline to Week 26   [ Time Frame: Baseline to Week 26 ]

10.  Secondary:   Change in Systolic Blood Pressure From Baseline to Week 26   [ Time Frame: Baseline to Week 26 ]

11.  Secondary:   Change in Diastolic Blood Pressure From Baseline to Week 26   [ Time Frame: Baseline to Week 26 ]

12.  Secondary:   Change in Heart Rate From Baseline to Week 26   [ Time Frame: Baseline to Week 26 ]

13.  Secondary:   Change in Fasting Plasma Glucose From Baseline to Week 26   [ Time Frame: Baseline to Week 26 ]

14.  Secondary:   Change Fasting Insulin From Baseline to Week 26   [ Time Frame: Baseline to Week 26 ]

15.  Secondary:   Change in Homeostasis Model Assessment-insulin Resistance (HOMA-IR) From Baseline to Week 26   [ Time Frame: Baseline to Week 26 ]

16.  Secondary:   Change in Patient-reported Binge Eating Scale (BES) Total Scores From Baseline to Week 26   [ Time Frame: Baseline to Week 26 ]

17.  Secondary:   Change in Patient-reported Arizona Sexual Experiences Scale (ASEX) Total Scores From Baseline to Week 26   [ Time Frame: Baseline to Week 26 ]

18.  Secondary:   Change in Patient-reported Impact of Weight on Quality of Life-Lite Questionnaire (IWQOL-Lite) Total Score From Baseline to Week 26   [ Time Frame: Baseline to Week 26 ]


  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: Executive Vice President, Head of Global Development
Organization: Orexigen Therapeutics, Inc.
phone: (858) 875-8600
e-mail: MedInfo@Orexigen.com



Responsible Party: Orexigen Therapeutics, Inc
ClinicalTrials.gov Identifier: NCT01764386     History of Changes
Other Study ID Numbers: NB-404
Study First Received: January 4, 2013
Results First Received: September 7, 2015
Last Updated: November 30, 2015
Health Authority: United States: Food and Drug Administration