Osteoarthritis
Conditions
Keywords
Osteoarthritis, Opioid, Transdermal
Brief summary
The purpose of the extension phase is to evaluate the long-term safety and tolerability of buprenorphine transdermal system (BTDS).
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. Transdermal systems may offer advantages over currently indicated oral products including ease and convenience of use, improved compliance, possible reduction in patient care, and prolonged and consistent delivery of drug.
Interventions
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
Sponsors
Purdue Pharma LP
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Subjects with moderate to severe osteoarthritic (OA) pain who completed all visits of the double-blind phase on study drug, or who discontinued study drug due to lack of therapeutic effect in the double-blind phase, but still completed all visits of the double-blind phase off study drug, are eligible to enroll in the extension phase.
Exclusion criteria
* Excluded from the study are subjects who ingest \> 2500 mg/day acetaminophen as part of their current stable nonopioid analgesic regimen. * Subjects requiring long-acting opioid analgesics \[once- or twice-daily dosing with an every (q) 24 hour (h) or q12h drug\] or transdermal fentanyl during the extension phase should be discontinued from the study. Refer to core study for additional inclusion/exclusion information.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 6 months. | Safety was assessed using reports of adverse events, clinical laboratory results, findings from physical examinations, and vital sign measurements. |
Countries
United States
Participant flow
Recruitment details
28-May-2003 (first patient first visit) to 02-Jul-2004 (last patient last visit of extension phase). This study was conducted at 11 medical/research sites in the U.S.
Pre-assignment details
All subjects meeting the protocol-specified definition of double blind phase completer were eligible to participate in the extension phase within 3 days. Completers were defined as those who either developed inadequate analgesia in the double-blind phase or completed all 28 days of the double-blind phase on study drug with adequate analgesia.
Participants by arm
| Arm | Count |
|---|---|
| Extension Phase (BTDS 5, 10, or 20) Buprenorphine transdermal patches of BTDS 5, 10, or 20 applied for 7-day wear | 290 |
| Total | 290 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Administrative | 4 |
| Overall Study | Adverse Event | 56 |
| Overall Study | Lack of Efficacy | 10 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Withdrawal by Subject | 14 |
Baseline characteristics
| Characteristic | Extension Phase (BTDS 5, 10, or 20) |
|---|---|
| Age Continuous | 60.4 years STANDARD_DEVIATION 9.28 |
| Sex: Female, Male Female | 197 Participants |
| Sex: Female, Male Male | 93 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 202 / 290 |
| serious Total, serious adverse events | 6 / 290 |
Outcome results
Primary
The Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Safety was assessed using reports of adverse events, clinical laboratory results, findings from physical examinations, and vital sign measurements.
Time frame: 6 months.
Population: The extension safety population consisted of all subjects who were exposed to BTDS and had at least 1 safety assessment during extension phase.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Extension Phase (BTDS 5, 10, or 20) | The Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Deaths | 0 participants | 0 |
| Extension Phase (BTDS 5, 10, or 20) | The Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Serious Adverse Events | 6 participants | — |
| Extension Phase (BTDS 5, 10, or 20) | The Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Adverse Events 4.5% | 202 participants | — |