Osteoarthritis
Conditions
Keywords
Osteoarthritis, Opioid, Transdermal
Brief summary
The purpose of this phase is to evaluate the long-term safety and tolerability of BTDS. Qualified subjects are started on BTDS 5 and the dose may be titrated, if necessary, to a maximum of BTDS 20 to achieve stable pain control.
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 5 mcg/h applied transdermally for 7-day wear.
Sponsors
Purdue Pharma LP
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects who completed all visits of the double-blind phase on study drug and subjects who discontinued study drug due to lack of therapeutic effect in the double-blind phase but completed all visits of the double-blind phase off study drug are eligible to enroll in the extension phase.
Exclusion criteria
* Subjects who prematurely discontinue study drug in the double-blind phase due to adverse event, subject's choice, administrative reason or lost to follow-up are NOT eligible to enter the extension phase * Subjects with electrocardiograms (ECGs) that show any QT data corrected for heart rate using Fridericia formula (QTcF) interval ≥ 500 millisecond (msec) will be discontinued from the extension phase. * 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 | 52 weeks | 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
02-Apr-2004 (first subject first visit, core study) to 05-Aug-2005 (last subject last visit, extension phase), in 82 sites in the US; 59 sites randomized at least 1 subject.
Pre-assignment details
Subjects with moderate to severe osteoarthritis (OA) pain who required opioid analgesia; 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 and completed all visits of the double-blind phase off study drug were eligible for the extension phase.
Participants by arm
| Arm | Count |
|---|---|
| Extension Phase Open-label buprenorphine transdermal patch 5, 10, 20 mcg/h applied for 7-day wear | 196 |
| Total | 196 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Administrative | 151 |
| Overall Study | Adverse Event | 20 |
| Overall Study | Lack of Efficacy | 8 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Withdrawal by Subject | 14 |
Baseline characteristics
| Characteristic | Extension Phase |
|---|---|
| Age Continuous | 58.4 years STANDARD_DEVIATION 9.83 |
| Sex: Female, Male Female | 150 Participants |
| Sex: Female, Male Male | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 93 / 196 |
| serious Total, serious adverse events | 14 / 196 |
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: 52 weeks
Population: The Extension Safety Population (N = 196) consisted of all subjects who received at least 1 dose of the open-label BTDS extension study drug, and had at least 1 safety assessment during the extension phase.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Extension Phase | The Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Deaths | 1 participants |
| Extension Phase | The Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Serious Adverse Events | 14 participants |
| Extension Phase | The Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Other Adverse Events in ≥ 4.5% of subjects | 93 participants |