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Trial record 81 of 186 for:    BUPRENORPHINE AND NALOXONE

Efficacy of BNX Sublingual Tablets Versus BNX Sublingual Film for Treatment of Opioid-Dependent Adults (ISTART)

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ClinicalTrials.gov Identifier: NCT01908842
Recruitment Status : Completed
First Posted : July 26, 2013
Results First Posted : May 22, 2015
Last Update Posted : May 10, 2017
Sponsor:
Collaborator:
Worldwide Clinical Trials
Information provided by (Responsible Party):
Orexo AB

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Opioid Dependence, on Agonist Therapy
Interventions Drug: BNX sublingual tablets
Drug: BNX sublingual film
Drug: Buprenorphine
Enrollment 759
Recruitment Details  
Pre-assignment Details A total of 759 patients were enrolled. One patient who was randomized did not receive study drug, making the participant flow total 758.
Arm/Group Title BNX Tablets, Then OL BNX Tablets, Then BNX Film Buprenorphine, Then OL BNX Film, Then BNX Tablets
Hide Arm/Group Description Days 1-2: BNX sublingual tablets (blinded induction); Days 3 to 14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit Days 1-2: Buprenorphine (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
Period Title: Induction
Started 383 375
Completed 357 344
Not Completed 26 31
Period Title: Switch to Other BNX Formulation (Day 15)
Started 357 344
Completed 287 279
Not Completed 70 65
Period Title: Day 22: Film (Col 1); Tablets (Col 2)
Started 287 279
Completed 262 262
Not Completed 25 17
Arm/Group Title BNX Tablets, Then OL BNX Tablets, Then BNX Film Buprenorphine, Then OL BNX Film, Then BNX Tablets Total
Hide Arm/Group Description Days 1-2: BNX sublingual tablets (blinded); Days 3-14: BNX sublingual tablets (open-label); Days 15-21: Switch to BNX sublingual film (open-label); Day 22: End of study visit Days 1-2: Generic buprenorphine sublingual tablets (blinded); Days 3 to 14: BNX sublingual film (open-label); Days 15-21: Switch to BNX sublingual tablets (open-label); Day 22: End of study visit Total of all reporting groups
Overall Number of Baseline Participants 383 375 758
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 383 participants 375 participants 758 participants
35.6  (11.3) 35.7  (11.3) 35.6  (11.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 383 participants 375 participants 758 participants
Female
167
  43.6%
139
  37.1%
306
  40.4%
Male
216
  56.4%
236
  62.9%
452
  59.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 383 participants 375 participants 758 participants
American Indian or Alaska Native
3
   0.8%
3
   0.8%
6
   0.8%
Asian
2
   0.5%
1
   0.3%
3
   0.4%
Native Hawaiian or Other Pacific Islander
2
   0.5%
0
   0.0%
2
   0.3%
Black or African American
51
  13.3%
49
  13.1%
100
  13.2%
White
318
  83.0%
312
  83.2%
630
  83.1%
More than one race
4
   1.0%
3
   0.8%
7
   0.9%
Unknown or Not Reported
3
   0.8%
7
   1.9%
10
   1.3%
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 383 participants 375 participants 758 participants
171.5  (9.3) 172.3  (9.4) 171.9  (9.4)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 383 participants 375 participants 758 participants
77.1  (18.7) 78.3  (18.4) 77.7  (18.6)
Body mass index  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 383 participants 375 participants 758 participants
26.2  (5.9) 26.3  (5.7) 26.3  (5.8)
Duration of opioid use  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 383 participants 375 participants 758 participants
10.7  (9.6) 10.5  (9.0) 10.6  (9.3)
1.Primary Outcome
Title Primary Endpoints of Retention in Treatment at Days 3 and 15
Hide Description Retention rates (number of patients retained) for the primary efficacy endpoints of retention in treatment at Days 3 and 15, which was defined as the number of patients who received treatment on Days 3 and 15.
Time Frame Day 3 and Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population
Arm/Group Title BNX Tablets, Then OL BNX Tablets, Then BNX Film Buprenorphine, Then OL BNX Film, Then BNX Tablets
Hide Arm/Group Description:
Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
Overall Number of Participants Analyzed 329 326
Measure Type: Number
Unit of Measure: participants
Retention at Day 3 309 302
Retention at Day 15 273 269
2.Secondary Outcome
Title Clinical Opiate Withdrawal Scale (COWS) Scores: Induction
Hide Description Absolute ± mean standard deviation values for COWS total scores at baseline; 0.5 h, 1.5 h, 3 h, and 6 h post dose on Day 1, and Day 2; COWS scores range from 0-48, with a lower score being more favorable
Time Frame Days 1 and 2
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Population - number of enrolled patients at the beginning of the measurement period
Arm/Group Title BNX Tablets, Then OL BNX Tablets, Then BNX Film Buprenorphine, Then OL BNX Film, Then BNX Tablets
Hide Arm/Group Description:
Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
Overall Number of Participants Analyzed 380 373
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 15.0  (4.2) 14.9  (4.3)
Day 1 0.5 h post dose 10.5  (4.6) 10.3  (4.7)
Day 1 1.5 h post dose 8.8  (4.6) 8.3  (4.5)
Day 1 3 h post dose 6.6  (5.1) 6.1  (5.1)
Day 1 6 h post dose 5.3  (4.1) 5.4  (4.6)
Day 2 8.0  (4.9) 7.6  (5.2)
3.Secondary Outcome
Title COWS Total Scores: Stabilization/Maintenance
Hide Description Absolute ± mean standard deviation values for COWS total scores at Days 3, 4, 8, 15, and 22; COWS scores range from 0-48, with a lower score being more favorable
Time Frame Days 3 through 22
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis population - - number of enrolled patients at the beginning of the measurement period
Arm/Group Title BNX Tablets, Then OL BNX Tablets, Then BNX Film Buprenorphine, Then OL BNX Film, Then BNX Tablets
Hide Arm/Group Description:
Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
Overall Number of Participants Analyzed 355 344
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 3 6.0  (4.2) 5.9  (4.4)
Day 4 5.2  (4.0) 5.1  (4.3)
Day 8 4.8  (3.9) 4.6  (3.9)
Day 15 4.1  (3.5) 3.7  (3.4)
Day 22: Film (col 1); Tablets (col 2) 3.4  (3.3) 3.3  (3.4)
4.Secondary Outcome
Title Subjective Opiate Withdrawal Scale (SOWS) Scores: Induction
Hide Description Absolute ± mean standard deviation values for SOWS total scores at baseline, 0.5 h, 1.5 h, 3 h, and 6 h post dose on Day 1, and Day 2; SOWS score ranges from 0-64, with a lower score being more favorable
Time Frame Days 1 and 2
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis population - number of enrolled patients at the beginning of the measurement period
Arm/Group Title BNX Tablets, Then OL BNX Tablets, Then BNX Film Buprenorphine, Then OL BNX Film, Then BNX Tablets
Hide Arm/Group Description:
Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
Overall Number of Participants Analyzed 376 367
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 31.7  (13.5) 33.0  (13.2)
Day 1 0.5 h post dose 22.7  (13.9) 23.0  (13.6)
Day 1 1.5 h post dose 19.1  (13.5) 17.8  (13.0)
Day 1 3 h post dose 13.6  (12.7) 13.0  (12.5)
Day 1 6 h post dose 10.7  (10.2) 11.1  (11.8)
Day 2 16.7  (12.3) 16.4  (13.4)
5.Secondary Outcome
Title SOWS Total Scores: Stabilization/Maintenance
Hide Description Absolute ± mean standard deviation values for SOWS total scores on Days 2, 3, 4, 8, 15, and 22; SOWS scores ranged from 0-64, with a lower score being more favorable
Time Frame Days 3 through 22
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Population - number of enrolled patients at the beginning of the measurement period
Arm/Group Title BNX Tablets, Then OL BNX Tablets, Then BNX Film Buprenorphine, Then OL BNX Film, Then BNX Tablets
Hide Arm/Group Description:
Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
Overall Number of Participants Analyzed 355 342
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 3 11.9  (10.4) 12.6  (11.2)
Day 4 10.1  (9.2) 10.2  (10.3)
Day 8 9.0  (9.2) 8.8  (9.6)
Day 15 7.2  (7.7) 6.7  (8.1)
Day 22: Film (col 1); Tablets (col 2) 6.8  (7.9) 7.3  (9.2)
6.Secondary Outcome
Title Visual Analog Scale (VAS) Cravings: Induction
Hide Description Absolute mean ± standard deviation values for VAS cravings at baseline, 0.5 h, 1.5 h, 3 h, and 6 post dose on Day 1, and Day 2; the VAS craving scores range from 0 ("no cravings") to 100 ("most intense craving I have ever had")
Time Frame Days 1 and 2
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Population - number of enrolled patients at the beginning of the measurement period
Arm/Group Title BNX Tablets, Then OL BNX Tablets, Then BNX Film Buprenorphine, Then OL BNX Film, Then BNX Tablets
Hide Arm/Group Description:
Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
Overall Number of Participants Analyzed 380 373
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 69.2  (23.5) 71.9  (22.0)
Day 1 0.5 h post dose 56.8  (26.5) 58.2  (26.4)
Day 1 1.5 h post dose 49.2  (28.9) 48.8  (27.9)
Day 1 3 h post dose 36.0  (28.2) 34.9  (27.8)
Day 1 6 h post dose 30.2  (26.2) 29.6  (26.9)
Day 2 45.3  (28.7) 44.9  (28.4)
7.Secondary Outcome
Title VAS Craving Scores: Stabilization/Maintenance
Hide Description Absolute mean ± standard deviation values for VAS cravings scores on Days 3, 4, 8, 15, and 22; the VAS craving scores range from 0 ("no cravings") to 100 ("most intense craving I have ever had")
Time Frame Days 3 through 22
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis population - number of enrolled patients at the beginning of the measurement period
Arm/Group Title BNX Tablets, Then OL BNX Tablets, Then BNX Film Buprenorphine, Then OL BNX Film, Then BNX Tablets
Hide Arm/Group Description:
Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
Overall Number of Participants Analyzed 356 344
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 3 33.7  (27.0) 34.5  (28.2)
Day 4 29.1  (26.2) 28.5  (26.4)
Day 8 26.2  (26.5) 23.7  (24.7)
Day 15 21.6  (23.9) 19.1  (23.4)
Day 22: Film (col 1); Tablets (col 2) 20.2  (22.9) 20.9  (23.8)
Time Frame Monitoring for adverse events was conducted from baseline through Day 22.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title BNX Tablets, Then OL BNX Tablets, Then BNX Film Buprenorphine, Then OL BNX Film, Then BNX Tablets
Hide Arm/Group Description Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
All-Cause Mortality
BNX Tablets, Then OL BNX Tablets, Then BNX Film Buprenorphine, Then OL BNX Film, Then BNX Tablets
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
BNX Tablets, Then OL BNX Tablets, Then BNX Film Buprenorphine, Then OL BNX Film, Then BNX Tablets
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/383 (0.78%)      1/375 (0.27%)    
Hepatobiliary disorders     
Elevated Transaminases  1 [1]  1/383 (0.26%)  1 0/375 (0.00%)  0
Injury, poisoning and procedural complications     
Worsening of pre-existing condition (foreign body in neck)  1 [2]  1/383 (0.26%)  1 0/375 (0.00%)  0
Nervous system disorders     
Convulsion  1 [2]  0/383 (0.00%)  0 1/375 (0.27%)  1
Respiratory, thoracic and mediastinal disorders     
Non-cardiac chest pain  1 [1]  1/383 (0.26%)  1 0/375 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
[1]
Serious adverse event reported during open-label maintenance phase.
[2]
Serious adverse event reported during blinded induction phase.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
BNX Tablets, Then OL BNX Tablets, Then BNX Film Buprenorphine, Then OL BNX Film, Then BNX Tablets
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   61/383 (15.93%)      55/375 (14.67%)    
Gastrointestinal disorders     
Vomiting  1 [1]  12/383 (3.13%)  12 11/375 (2.93%)  11
Nausea  1 [1]  8/383 (2.09%)  8 15/375 (4.00%)  15
Dry mouth  1 [1]  8/383 (2.09%)  8 2/375 (0.53%)  2
Constipation  1 [1]  4/383 (1.04%)  4 3/375 (0.80%)  3
Nervous system disorders     
Headache  1 [1]  20/383 (5.22%)  20 19/375 (5.07%)  19
Somnolence  1 [1]  6/383 (1.57%)  6 2/375 (0.53%)  2
Psychiatric disorders     
Insomnia  1 [1]  5/383 (1.31%)  5 4/375 (1.07%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
[1]
Adverse events reported during the blinded induction phase.
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: Dr. Erik Gunderson, MD, FASAM
Organization: University of Virginia
Phone: (434) 202-8612
EMail: EWG2N@hscmail.mcc.virginia.edu
Layout table for additonal information
Responsible Party: Orexo AB
ClinicalTrials.gov Identifier: NCT01908842     History of Changes
Other Study ID Numbers: OX219-006 Protocol Amendment 4
First Submitted: July 19, 2013
First Posted: July 26, 2013
Results First Submitted: April 8, 2015
Results First Posted: May 22, 2015
Last Update Posted: May 10, 2017