Osteoarthritis
Conditions
Keywords
Osteoarthritis, opioid, transdermal
Brief summary
The objective of this study is to evaluate the safety and efficacy of dose conversion from hydrocodone/ acetaminophen (Vicodin®) to the buprenorphine transdermal system (Butrans™) in subjects with osteoarthritis pain of the hip or knee. The double-blind treatment intervention duration is 2 weeks during which time supplemental analgesic medication will be allowed.
Detailed description
Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.
Interventions
Buprenorphine transdermal patch applied for 7-day wear.
Sponsors
Purdue Pharma LP
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
\- osteoarthritis of the hip or knee taking a regularly scheduled regimen of hydrocodone/ acetaminophen for their osteoarthritis OA pain.
Exclusion criteria
* currently have condition requiring a stable regimen of acetaminophen (APAP). * a history of chronic conditions, other than OA of the hip or knee joints, requiring frequent, intermittent analgesic therapy. Other protocol-specific exclusion/inclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Subjects Who Completed the 14-day Double-blind Phase. | 14 days | 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). |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Double-blind BTDS 10/20 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. | 101 |
| Double-blind BTDS 20 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. | 103 |
| Total | 204 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative | 4 | 2 |
| Overall Study | Adverse Event | 10 | 16 |
| Overall Study | Lack of Efficacy | 1 | 2 |
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Double-blind BTDS 10/20 | Double-blind BTDS 20 | Total |
|---|---|---|---|
| Age Continuous | 57.4 years STANDARD_DEVIATION 10.1 | 58.9 years STANDARD_DEVIATION 9.97 | 58.2 years STANDARD_DEVIATION 10.04 |
| Sex: Female, Male Female | 63 Participants | 73 Participants | 136 Participants |
| Sex: Female, Male Male | 38 Participants | 30 Participants | 68 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 31 / 101 | 47 / 103 | 15 / 266 |
| serious Total, serious adverse events | 2 / 101 | 3 / 103 | 0 / 266 |
Outcome results
Primary
The Percentage of Subjects Who Completed the 14-day Double-blind Phase.
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double-blind BTDS 10/20 | The Percentage of Subjects Who Completed the 14-day Double-blind Phase. | more than 22.5 - 30 mg HCD (Stratum 2) | 85 Percentage of Participants |
| Double-blind BTDS 10/20 | The Percentage of Subjects Who Completed the 14-day Double-blind Phase. | 15 - 22.5 mg HCD (Stratum 1) | 88 Percentage of Participants |
| Double-blind BTDS 10/20 | The Percentage of Subjects Who Completed the 14-day Double-blind Phase. | Overall | 87 Percentage of Participants |
| Double-blind BTDS 20 | The Percentage of Subjects Who Completed the 14-day Double-blind Phase. | more than 22.5 - 30 mg HCD (Stratum 2) | 79 Percentage of Participants |
| Double-blind BTDS 20 | The Percentage of Subjects Who Completed the 14-day Double-blind Phase. | 15 - 22.5 mg HCD (Stratum 1) | 83 Percentage of Participants |
| Double-blind BTDS 20 | The Percentage of Subjects Who Completed the 14-day Double-blind Phase. | Overall | 82 Percentage of Participants |
| Combined Total | The Percentage of Subjects Who Completed the 14-day Double-blind Phase. | 15 - 22.5 mg HCD (Stratum 1) | 85 Percentage of Participants |
| Combined Total | The Percentage of Subjects Who Completed the 14-day Double-blind Phase. | Overall | 84 Percentage of Participants |
| Combined Total | The Percentage of Subjects Who Completed the 14-day Double-blind Phase. | more than 22.5 - 30 mg HCD (Stratum 2) | 82 Percentage of Participants |