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Safety and Efficacy of Dose Conversion From Vicodin® to Buprenorphine Transdermal System (Butrans™) in Subjects With OA Pain

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ClinicalTrials.gov Identifier: NCT00312572
Recruitment Status : Completed
First Posted : April 10, 2006
Results First Posted : September 23, 2010
Last Update Posted : September 3, 2012
Sponsor:
Information provided by (Responsible Party):
Purdue Pharma LP

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Osteoarthritis
Intervention Drug: Buprenorphine transdermal patch
Enrollment 204
Recruitment Details Study dates: 26-Jun-2003 (first patient first visit) to 21-Jul-2004 (last patient last visit) in 29 medical/research centers in the United States.
Pre-assignment Details N = 266 subjects received a stable regimen of Vicodin® in the Run-in period and were eligible for randomization if they reported a daily “average pain over the last 24 hours” score of 0=none or 1=mild on at least 5 of the 7 days; and used ≤ 2 doses of supplemental analgesic per day for their osteoarthritic (OA) pain. N = 204 completed the run-in.
Arm/Group Title Double-blind BTDS 10/20 Double-blind BTDS 20
Hide Arm/Group Description Initial doses (Level 1) of BTDS 10. Subjects were allowed to have their dose adjusted to BTDS 20 (Level 2) on or after day 4. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted. Initial doses (Level 1) of BTDS 20. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted.
Period Title: Overall Study
Started 101 103
Completed 85 82
Not Completed 16 21
Reason Not Completed
Adverse Event             10             16
Lost to Follow-up             1             1
Administrative             4             2
Lack of Efficacy             1             2
Arm/Group Title Double-blind BTDS 10/20 Double-blind BTDS 20 Total
Hide Arm/Group Description Initial doses (Level 1) of BTDS 10. Subjects were allowed to have their dose adjusted to BTDS 20 (Level 2) on or after day 4. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted. Initial doses (Level 1) of BTDS 20. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted. Total of all reporting groups
Overall Number of Baseline Participants 101 103 204
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 101 participants 103 participants 204 participants
57.4  (10.10) 58.9  (9.97) 58.2  (10.04)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants 103 participants 204 participants
Female
63
  62.4%
73
  70.9%
136
  66.7%
Male
38
  37.6%
30
  29.1%
68
  33.3%
1.Primary Outcome
Title The Percentage of Subjects Who Completed the 14-day Double-blind Phase.
Hide Description The indicator variable was 1 = completion, and 0 = noncompletion. For the primary efficacy analysis, the percentage of subjects who completed the double-blind phase was computed with its 95% confidence interval (CI) for each treatment regimen (starting dose of BTDS 10 or BTDS 20) across and within baseline Vicodin® stratum (15 to 22.5mg/day vs >22.5 to 30 mg/day as determined by the daily average hydrocodone dose during the run-in period).
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Population: (N = 198) consisted of all subjects who were randomized into the double-blind phase, received at least 1 dose of BTDS during the double-blind phase, and had at least 1 efficacy observation during the double-blind phase, and had no evidence of impaired liver function at screening and prerandomization.
Arm/Group Title Double-blind BTDS 10/20 Double-blind BTDS 20 Combined Total
Hide Arm/Group Description:
Initial doses (Level 1) of BTDS 10. Subjects were allowed to have their dose adjusted to BTDS 20 (Level 2) on or after day 4. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted.
Initial doses (Level 1) of BTDS 20. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted.
Combined percentages from BTDS 10/20 and BTDS 20
Overall Number of Participants Analyzed 98 100 198
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
15 - 22.5 mg HCD (Stratum 1)
88
(79.9 to 95.1)
83
(74.7 to 91.9)
85
(79.7 to 91.2)
more than 22.5 - 30 mg HCD (Stratum 2)
85
(70.8 to 98.5)
79
(63.4 to 93.8)
82
(71.1 to 91.8)
Overall
87
(80.0 to 93.5)
82
(74.5 to 89.5)
84
(79.3 to 89.4)
Time Frame Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and followed until resolution or 30 days after the last dose of study drug, or discontinuation; serious AEs were followed until the AE stabilized
Adverse Event Reporting Description AEs were learned of through spontaneous reports and subject interview.
 
Arm/Group Title Double-blind BTDS 10/20 Double-blind BTDS 20 Open-label Run-in Period - Vicodin
Hide Arm/Group Description Initial doses (Level 1) of BTDS 10. Subjects were allowed to have their dose adjusted to BTDS 20 (Level 2) on or after day 4. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted. Initial doses (Level 1) of BTDS 20. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted. N = 266 subjects received a stable regimen of Vicodin® in the Run-in period and were eligible for randomization if they reported a daily “average pain over the last 24 hours” score of 0 = none or 1 = mild on at least 5 of the 7 days; and used ≤ 2 doses of supplemental analgesic per day for their osteoarthritic (OA) pain. N = 204 completed the run-in.
All-Cause Mortality
Double-blind BTDS 10/20 Double-blind BTDS 20 Open-label Run-in Period - Vicodin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Double-blind BTDS 10/20 Double-blind BTDS 20 Open-label Run-in Period - Vicodin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/101 (1.98%)      3/103 (2.91%)      0/266 (0.00%)    
Infections and infestations       
Creutzfeldt-Jacob disease - DEATH  1 [1]  0/101 (0.00%)  0 1/103 (0.97%)  1 0/266 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Leg pain  1 [2]  0/101 (0.00%)  0 1/103 (0.97%)  1 0/266 (0.00%)  0
Myositis  1 [2]  0/101 (0.00%)  0 1/103 (0.97%)  1 0/266 (0.00%)  0
Nervous system disorders       
Headache  1 [2]  0/101 (0.00%)  0 1/103 (0.97%)  1 0/266 (0.00%)  0
Psychiatric disorders       
Exacerbation of anxiety disorder  1 [2]  1/101 (0.99%)  1 0/103 (0.00%)  0 0/266 (0.00%)  0
Skin and subcutaneous tissue disorders       
Rash NOS, Chest, Arms, Face  1 [2]  2/101 (1.98%)  2 0/103 (0.00%)  0 0/266 (0.00%)  0
Rash generalized  1 [2]  1/101 (0.99%)  1 0/103 (0.00%)  0 0/266 (0.00%)  0
Vascular disorders       
Increased hypertension  1 [2]  0/101 (0.00%)  0 1/103 (0.97%)  1 0/266 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (5.1)
[1]
DEATH Systematic and nonsystematic assessments
[2]
Systematic and nonsystematic assessments
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4.50%
Double-blind BTDS 10/20 Double-blind BTDS 20 Open-label Run-in Period - Vicodin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   31/101 (30.69%)      47/103 (45.63%)      15/266 (5.64%)    
Gastrointestinal disorders       
Nausea  1  10/101 (9.90%)  10/103 (9.71%)  4/266 (1.50%) 
Vomiting NOS  1  6/101 (5.94%)  7/103 (6.80%)  3/266 (1.13%) 
General disorders       
Application site erythema  1  7/101 (6.93%)  7/103 (6.80%)  0/266 (0.00%) 
Application site pruritus  1  11/101 (10.89%)  18/103 (17.48%)  0/266 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  2/101 (1.98%)  8/103 (7.77%)  0/266 (0.00%) 
Nervous system disorders       
Dizziness  1  3/101 (2.97%)  7/103 (6.80%)  1/266 (0.38%) 
Headache  1  9/101 (8.91%)  9/103 (8.74%)  6/266 (2.26%) 
Somnolence  1  7/101 (6.93%)  9/103 (8.74%)  1/266 (0.38%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (5.1)
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Leader
Organization: Purdue Pharma L.P.
Phone: 800-733-1333
Layout table for additonal information
Responsible Party: Purdue Pharma LP
ClinicalTrials.gov Identifier: NCT00312572     History of Changes
Other Study ID Numbers: BUP3018
First Submitted: April 7, 2006
First Posted: April 10, 2006
Results First Submitted: July 29, 2010
Results First Posted: September 23, 2010
Last Update Posted: September 3, 2012