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Trial record 96 of 186 for:    BUPRENORPHINE AND NALOXONE

Multi-Center, Open-Label, 24-Week Study of OX219 Safety and Efficacy for Maintenance Treatment of Opioid Dependence

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.
 
ClinicalTrials.gov Identifier: NCT01903005
Recruitment Status : Completed
First Posted : July 19, 2013
Results First Posted : October 28, 2015
Last Update Posted : October 28, 2015
Sponsor:
Collaborator:
Worldwide Clinical Trials
Information provided by (Responsible Party):
Orexo AB

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Opioid Dependence, on Agonist Therapy
Intervention Drug: Higher bioavailability BNX sublingual tablets
Enrollment 668
Recruitment Details  
Pre-assignment Details A total of 668 patients who completed primary study OX219-006 (NCT01908842) or OX219-007 (NCT01848054) were enrolled. Three patients entered the study without taking any study medication and were excluded. A total of 665 patients were included in the data analyses.
Arm/Group Title Safety Population
Hide Arm/Group Description Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
Period Title: Overall Study
Started 665 [1]
Completed 292 [2]
Not Completed 373
[1]
Primary study OX219-006 (n=475); Primary study OX219-007 (n=190)
[2]
Primary study OX219-006 (n=194); Primary study OX219-007 (n=98)
Arm/Group Title OX219-006 Completers OX219-007 Completers Total
Hide Arm/Group Description Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg and 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects. Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg and 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects. Total of all reporting groups
Overall Number of Baseline Participants 475 190 665
Hide Baseline Analysis Population Description
Safety population
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 475 participants 190 participants 665 participants
35.9  (11.4) 39.0  (10.8) 36.8  (11.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 475 participants 190 participants 665 participants
Female
196
  41.3%
63
  33.2%
259
  38.9%
Male
279
  58.7%
127
  66.8%
406
  61.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 475 participants 190 participants 665 participants
Hispanic or Latino
65
  13.7%
17
   8.9%
82
  12.3%
Not Hispanic or Latino
410
  86.3%
173
  91.1%
583
  87.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 475 participants 190 participants 665 participants
American Indian or Alaska Native
2
   0.4%
0
   0.0%
2
   0.3%
Asian
1
   0.2%
0
   0.0%
1
   0.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
62
  13.1%
21
  11.1%
83
  12.5%
White
402
  84.6%
167
  87.9%
569
  85.6%
More than one race
3
   0.6%
2
   1.1%
5
   0.8%
Unknown or Not Reported
5
   1.1%
0
   0.0%
5
   0.8%
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 475 participants 190 participants 665 participants
171.99  (9.43) 173.35  (10.01) 172.38  (9.61)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 475 participants 190 participants 665 participants
78.34  (18.99) 78.98  (20.73) 78.53  (19.49)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 475 participants 190 participants 665 participants
26.47  (6.11) 26.26  (6.63) 26.41  (6.26)
Duration of Opioid Use  
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 475 participants 190 participants 665 participants
7.20  (9.50) 9.6  (8.79) 7.95  (9.32)
1.Primary Outcome
Title Number of Patients Reporting Treatment-Emergent Adverse Events
Hide Description Number of patients reporting treatment-emergent adverse events during open-label, extension treatment with higher bioavailability BNX sublingual tablets
Time Frame Day 1 through week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Safety Population
Hide Arm/Group Description:
Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
Overall Number of Participants Analyzed 665
Measure Type: Number
Unit of Measure: participants
Constipation 20
Headache 21
2.Primary Outcome
Title Number of Patients Reporting Treatment-Related, Treatment-Emergent Adverse Events
Hide Description Treatment-emergent adverse events considered related to treatment with the higher bioavailability BNX sublingual tablets
Time Frame Day 1 through week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Safety Population
Hide Arm/Group Description:
Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
Overall Number of Participants Analyzed 665
Measure Type: Number
Unit of Measure: participants
Gastrointestinal disorders 32
Constipation 19
3.Primary Outcome
Title Number of Patients Reporting Treatment-Emergent Serious Adverse Events
Hide Description Patients reporting treatment-emergent serious adverse events considered either related or not related to treatment with the higher bioavailability BNX sublingual tablets
Time Frame Day 1 throught week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Safety Population
Hide Arm/Group Description:
Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
Overall Number of Participants Analyzed 665
Measure Type: Number
Unit of Measure: participants
Possibly treatment-related 1
Not treatment-related 8
4.Primary Outcome
Title Number of Patient Discontinuations Due to Treatment-Emergent Adverse Events
Hide Description Study discontinuations due to treatment-emergent adverse events that occurred during treatment with bioavailability BNX sublingual tablets
Time Frame Day 1 through week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Safety Population
Hide Arm/Group Description:
Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
Overall Number of Participants Analyzed 665
Measure Type: Number
Unit of Measure: participants
14
5.Secondary Outcome
Title Retention in Treatment in the Safety Population
Hide Description Retention in treatment by visit in the safety population at weeks 4, 8, 12, 16, 20, and 24, defined as the number of patients receiving treatment on the day of the visit (± 5 days for each visit)
Time Frame Treatment retention was assessed at weeks 4, 8, 12, 16, 20, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Safety Population
Hide Arm/Group Description:
Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
Overall Number of Participants Analyzed 665
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: participants
Week 4
563
(545 to 581)
Week 8
483
(460 to 505)
Week 12
425
(401 to 450)
Week 16
383
(358 to 408)
Week 20
333
(308 to 358)
Week 24
292
(267 to 317)
6.Secondary Outcome
Title Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Clinical Opioid Withdrawal Scale (COWS) Score
Hide Description Mean change from primary study baseline in COWS total scores during the 24-week open-label, extension study; COWS scores range from 0 to 48, with a lower score being more favorable; study endpoint was defined as the last post-baseline value recorded for COWS
Time Frame Prior to dosing on day 1, at weeks 4, 8,12,16, 20, 24, and at study endpoint
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population; patient population at day 1 (n=658) is lower than overall safety population (n=665) due to missing data
Arm/Group Title Safety Population
Hide Arm/Group Description:
Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
Overall Number of Participants Analyzed 665
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Day 1 (n=658)
-12.0
(-12.3 to -11.6)
Week 4 (n=557)
-12.2
(-12.6 to -11.8)
Week 8 (n=477)
-12.7
(-13.1 to -12.3)
Week 12 (n=423)
-12.9
(-13.4 to -12.5)
Week 16 (n=384)
-13.1
(-13.6 to -12.6)
Week 20 (n=336)
-13.3
(-13.8 to -12.8)
Week 24 (completers only; n=288)
-13.1
(-13.7 to -12.6)
Study Endpoint (n=597)
-12.5
(-12.9 to -12.1)
7.Secondary Outcome
Title Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Subjective Opioid Withdrawal Scale (SOWS) Score
Hide Description Mean change from primary study baseline in SOWS total scores during the 24-week open-label, extension study; SOWS scores range from 0 to 64, with a lower score being more favorable; study endpoint was defined as the last post-baseline value recorded for SOWS
Time Frame Prior to dosing on day 1, at weeks 4, 8,12,16, 20, and 24, and at study endpoint
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population; patient population at day 1 (n=650) is lower than overall safety population (n=665) due to missing data
Arm/Group Title Safety Population
Hide Arm/Group Description:
Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
Overall Number of Participants Analyzed 665
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Day 1 (n=650)
-26.8
(-27.8 to -25.7)
Week 4 (n=550)
-27.4
(-28.6 to -26.2)
Week 8 (n=472)
-28.0
(-29.2 to -26.7)
Week 12 (n=418)
-27.7
(-29.0 to -26.3)
Week 16 (n=376)
-28.7
(-30.1 to -27.3)
Week 20 (n=331)
-28.9
(-30.4 to -27.5)
Week 24 (n=282)
-27.7
(-29.4 to -26.0)
Study Endpoint (n=588)
-27.3
(-28.5 to -26.1)
8.Secondary Outcome
Title Mean Change From Primary Study Baseline (OX219-006 and OX219-007) in Visual Analog Scale (VAS) Craving Scores
Hide Description Mean change from primary study baseline in VAS craving scores during the 24-week open-label, extension study; VAS craving scores range from 0 ("no cravings") to 100 mm ("most intense craving I have ever had"); study endpoint was defined as the last post-baseline value recorded for VAS craving
Time Frame Prior to dosing on day 1, at weeks 4, 8, 12, 16, 20, and 24, and at study endpoint
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population; patient population at day 1 (n=646) is lower than overall safety population (n=665) due to missing data
Arm/Group Title Safety Population
Hide Arm/Group Description:
Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
Overall Number of Participants Analyzed 665
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Day 1 (n=646)
-52.8
(-55.0 to -50.6)
Week 4 (n=563)
-56.6
(-59.0 to -54.2)
Week 8 (n=479)
-59.4
(-62.0 to -56.9)
Week 12 (n=426)
-59.4
(-62.0 to -56.8)
Week 16 (n=384)
-61.5
(-64.1 to -58.8)
Week 20 (n=338)
-61.4
(-64.3 to -58.5)
Week 24 (n=289)
-60.5
(-63.8 to -57.2)
Study Endpoint (n=598)
-57.3
(-59.6 to -55.0)
9.Secondary Outcome
Title Percent Change From Primary Study Baseline (OX219-006 or OX219-007) for Question 1 of the Work Productivity/Activity Impairment: 6-Question Specific Health Problem Questionnaire (WPAI:SHP)
Hide Description Question 1 of the WPAI:SHP asks patients to provide a "yes" or "no" response to the question "Are you employed?"; The percentage of patients employed at the end of the 24-week open-label, extension study was calculated by subtracting the percentage of previously employed patients not employed at study end from the percentage of previously unemployed patients who were employed by study end
Time Frame Study Endpoint
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population; patients with missing data were excluded from the analysis and are reflected in the number of patients analyzed
Arm/Group Title Safety Population
Hide Arm/Group Description:
Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
Overall Number of Participants Analyzed 665
Measure Type: Number
Unit of Measure: percentage of patients
Unemployed at baseline; employed at study endpoint 21.3
Employed at baseline; unemployed at study endpoint 6.0
Increase in patients employed at study endpoint 15.3
10.Secondary Outcome
Title Mean Change From Primary Study Baseline (OX219-006 or OX219-007) for Questions 2-4 of the WPAI:SHP
Hide Description Mean change from primary study baseline to week 24 of the open-label, extension study for questions 2-4 of the WPAI:SHP; Question 2: During the past 7 days, how many hours did you miss from work because of problems associated with your opioid dependence?; Question 3: During the past 7 days, how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study?; Question 4: During the past 7 days, how many hours did you actually work?
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population; patients with missing data were excluded from the analysis and are reflected in the number of participants analyzed
Arm/Group Title Safety Population
Hide Arm/Group Description:
Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
Overall Number of Participants Analyzed 665
Mean (95% Confidence Interval)
Unit of Measure: hours
Missed work hours due to opioid dependence (n=79)
-4.8
(-8.1 to -1.5)
Missed work hours due to other reason (n=79)
-0.2
(-1.9 to 1.5)
Number of hours actually worked (n=78)
7.7
(3.4 to 12.0)
11.Secondary Outcome
Title Mean Change From Primary Study Baseline (OX219-006 or OX219-007) for Questions 5-6 of the WPAI:SHP
Hide Description Mean change from primary study baseline to week 24 of the open-label extension study for questions 5-6 of the WPAI:SHP; Question 5: During the past 7 days, how much did your opioid dependence affect your productivity while you were working?; Question 6: During the past 7 days, how much did your opioid dependence affect your ability to do regular daily activities, other than work at a job?; Questions 5 and 6 of the WPAI:SHP are scored on an 11-point scale (0 = problem had no effect; 10 = problem completely prevented me from doing my work/daily activities)
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population; patients with missing data were excluded from the analysis and are reflected in the number of participants analyzed
Arm/Group Title Safety Population
Hide Arm/Group Description:
Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
Overall Number of Participants Analyzed 665
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Problem affects work productivity (n=70)
-3.9
(-4.7 to -3.1)
Problem affects daily activities (n=283)
-4.3
(-4.8 to -3.9)
Time Frame Day 1 through Week 24 of Open-Label Extension Study
Adverse Event Reporting Description Safety population (N=665)
 
Arm/Group Title Safety Population
Hide Arm/Group Description Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses of buprenorphine/naloxone between 5.7/1.4 mg and 17.1/4.2 mg mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
All-Cause Mortality
Safety Population
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Safety Population
Affected / at Risk (%) # Events
Total   15/665 (2.26%)    
Cardiac disorders   
Hypertensive and atherosclerotic cardiovascular disease  1 [1]  1/665 (0.15%)  1
Infections and infestations   
Respiratory syncytial virus bronchitis  1 [2]  1/665 (0.15%)  1
Anal abscess  1 [3]  1/665 (0.15%)  1
Urinary tract infection  1 [4]  1/665 (0.15%)  1
Injury, poisoning and procedural complications   
Heroin toxicity  1 [5]  1/665 (0.15%)  1
Arthropod bite  1 [2]  1/665 (0.15%)  1
Overdose  1 [4]  1/665 (0.15%)  1
Multiple fractures  1 [4]  1/665 (0.15%)  1
Nervous system disorders   
Metabolic encephalopathy  1 [4]  1/665 (0.15%)  1
Psychiatric disorders   
Depression  1 [6]  2/665 (0.30%)  2
Worsening of opioid dependence  1 [7]  2/665 (0.30%)  2
Bipolar depression  1 [8]  1/665 (0.15%)  1
Respiratory, thoracic and mediastinal disorders   
Non-small cell lung cancer  1 [2]  1/665 (0.15%)  1
Chronic obstructive pulmonary disease  1 [2]  1/665 (0.15%)  1
Asthma  1 [2]  1/665 (0.15%)  1
Social circumstances   
Intentional overdose  1 [9]  1/665 (0.15%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0.
[1]
Condition led to death; non-treatment-emergent, not related to study drug.
[2]
Moderate, treatment-emergent; not related to study drug.
[3]
Severe, treatment-emergent; unlikely related to study drug.
[4]
Severe, treatment-emergent; not related to study drug.
[5]
Condition led to death; non-treatment-emergent; not related to study drug.
[6]
Mild, treatment-emergent; not related to study drug in one patient; severe, treatment-emergent; possibly related to study drug in another patient.
[7]
Moderate, non-treatment-emergent; not related to study drug in two patients.
[8]
Severe, non-treatment-emergent; unlikely related to study drug.
[9]
Severe, non-treatment-emergent; not related to study drug.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Safety Population
Affected / at Risk (%) # Events
Total   41/665 (6.17%)    
Gastrointestinal disorders   
Constipation  1 [1]  20/665 (3.01%)  22
Nervous system disorders   
Headache  1 [1]  21/665 (3.16%)  22
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0.
[1]
Treatment-emergent.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kent Hoffman, DO
Organization: TRY Research
Phone: (407) 691-3960
EMail: Suboxdoc1@yahoo.com
Layout table for additonal information
Responsible Party: Orexo AB
ClinicalTrials.gov Identifier: NCT01903005     History of Changes
Other Study ID Numbers: OX219-008
First Submitted: July 9, 2013
First Posted: July 19, 2013
Results First Submitted: August 17, 2015
Results First Posted: October 28, 2015
Last Update Posted: October 28, 2015