Osteoarthritis
Conditions
Keywords
osteoarthritis, opioid, transdermal
Brief summary
The original objective of this study was to assess the safety and efficacy of the buprenorphine transdermal system (BTDS) (5, 10, and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain. However, this study was terminated early with only 35% of the planned sample size, therefore the primary objective is changed to focus on the safety evaluations.
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.
Placebo to match buprenorphine transdermal patch 10 or 20.
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 No maximum
Healthy volunteers
No
Inclusion criteria
* clinical evidence of osteoarthritis of the hip, knee, or spine joint for ≥ 1 year currently adequately treated with short acting opioids. * taking ≥ 30 and ≤ 80 mg oral morphine or morphine equivalents per day for ≥ 2 weeks for control of their osteoarthritis pain.
Exclusion criteria
* requiring frequent analgesic therapy for chronic condition(s), other than osteoarthritis of the hip, knee, or spine. * scheduled for surgery of the disease site (e.g., major joint replacement surgery), or any other major surgery that would fall within the study period. Other protocol-specific exclusion/inclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) as a Measure of Safety | 483 days | For the Run-in and double-blind phases of the study, the focus of this study was changed before unblinding to a safety study due to early termination and having enrolled only 35% of the planned sample size. Therefore, the safety data is presented for the run-in and double-blind and overall exposure to BTDS, which includes the extension phase. |
Countries
United States
Participant flow
Recruitment details
12-Dec-2003 (First Patient First Visit) 02-Mar-2005 (Last Patient Last Visit of Extension). At the time of early termination, 39 centers had screened subjects, 22 centers had randomized subjects to the double-blind phase.
Pre-assignment details
All subjects (N = 159) in the run-in period received BTDS 5 for the first 3 days, titrated to BTDS 10 or 20, continued stable nonopioid analgesic regimen for osteoarthritis (OA) pain, and took oxycodone immediate-release 5-mg capsules as supplemental analgesic therapy for primary OA pain site. N = 107 completed the run-in and were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Double-blind Placebo Patch Reference Treatment placebo 10 or 20 applied for 7-day wear | 51 |
| Double-blind BTDS Test treatments buprenorphine transdermal patch (BTDS) 10 or BTDS 20 applied for 7-day wear | 56 |
| Total | 107 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Administrative | 0 | 3 | 8 | 21 |
| Overall Study | Adverse Event | 2 | 4 | 23 | 3 |
| Overall Study | Did not qualify | 0 | 0 | 1 | 0 |
| Overall Study | Lack of Efficacy | 0 | 0 | 20 | 1 |
| Overall Study | Lost to Follow-up | 1 | 2 | 0 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 3 | 0 | 2 |
Baseline characteristics
| Characteristic | Total | Double-blind Placebo Patch | Double-blind BTDS |
|---|---|---|---|
| Age Continuous | 60.3 years STANDARD_DEVIATION 10.45 | 61.2 years STANDARD_DEVIATION 11.36 | 59.4 years STANDARD_DEVIATION 9.56 |
| Sex: Female, Male Female | 72 Participants | 33 Participants | 39 Participants |
| Sex: Female, Male Male | 35 Participants | 18 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 14 / 51 | 22 / 56 | 60 / 159 | 82 / 159 |
| serious Total, serious adverse events | 1 / 51 | 2 / 56 | 1 / 159 | 5 / 159 |
Outcome results
Primary
Number of Participants With Adverse Events (AEs) as a Measure of Safety
For the Run-in and double-blind phases of the study, the focus of this study was changed before unblinding to a safety study due to early termination and having enrolled only 35% of the planned sample size. Therefore, the safety data is presented for the run-in and double-blind and overall exposure to BTDS, which includes the extension phase.
Time frame: 483 days
Population: The full analysis population consisted of all subjects who were randomized into the double-blind phase and received at least 1 dose of double-blind treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double-blind Placebo | Number of Participants With Adverse Events (AEs) as a Measure of Safety | Death | 0 participants |
| Double-blind Placebo | Number of Participants With Adverse Events (AEs) as a Measure of Safety | All Other Adverse Events in ≥ 4.5% of Subjects | 14 participants |
| Double-blind Placebo | Number of Participants With Adverse Events (AEs) as a Measure of Safety | Serious adverse events | 1 participants |
| Double-blind BTDS | Number of Participants With Adverse Events (AEs) as a Measure of Safety | Death | 1 participants |
| Double-blind BTDS | Number of Participants With Adverse Events (AEs) as a Measure of Safety | All Other Adverse Events in ≥ 4.5% of Subjects | 22 participants |
| Double-blind BTDS | Number of Participants With Adverse Events (AEs) as a Measure of Safety | Serious adverse events | 2 participants |
| Run-in Period | Number of Participants With Adverse Events (AEs) as a Measure of Safety | Serious adverse events | 1 participants |
| Run-in Period | Number of Participants With Adverse Events (AEs) as a Measure of Safety | All Other Adverse Events in ≥ 4.5% of Subjects | 60 participants |
| Run-in Period | Number of Participants With Adverse Events (AEs) as a Measure of Safety | Death | 0 participants |
| Overall BTDS Exposure | Number of Participants With Adverse Events (AEs) as a Measure of Safety | All Other Adverse Events in ≥ 4.5% of Subjects | 82 participants |
| Overall BTDS Exposure | Number of Participants With Adverse Events (AEs) as a Measure of Safety | Death | 1 participants |
| Overall BTDS Exposure | Number of Participants With Adverse Events (AEs) as a Measure of Safety | Serious adverse events | 5 participants |