Back Pain Lower Back Chronic
Conditions
Keywords
Low back pain, Opioid, Transdermal
Brief summary
The purpose of the extension phase is to evaluate the long-term safety and tolerability of buprenorphine transdermal system (BTDS). Subjects begin the extension phase on BTDS 5 mcg/h and may up- or down-titrate the dose \[up to BTDS 20 micrograms (mcg) / hour (h)\] depending on adequate pain relief and tolerability.
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 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
18 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. * For subjects entering the extension, 4 electrocardiograms (ECGs) are required at entry if none were collected prior to randomization while on BTDS 20. NOTE: Subjects with any 1 QT data corrected for heart rate using the Fridericia formula (QTcF) interval ≥ 500 milliseconds (msec) would be discontinued from the extension phase
Exclusion criteria
* Subjects requiring long-acting opioid analgesics \[once- or twice-daily dosing with a every (q) 24 hours (h) or q12h drug\] or transdermal fentanyl during the extension phase should be discontinued from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) as a Measure of Safety | 52-week extension phase | The purpose of the extension phase was to evaluate the long-term safety and tolerability of BTDS in subjects who had participated in the core study (BUP3015). |
Countries
United States
Participant flow
Recruitment details
Study dates: 17-Jun-2004 to 23-Sep-2005 at 52 medical/research sites in the United States participated in the extension study.
Pre-assignment details
Subjects who completed all visits of the 12-week double-blind phase on study drug as well as subjects who both 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 enrollment in the extension phase.
Participants by arm
| Arm | Count |
|---|---|
| Total BTDS 5, 10, 20 Test treatment: Open-label buprenorphine transdermal patch 5, 10, or 20 mcg/h applied for 7-day wear | 354 |
| Total | 354 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Administrative | 223 |
| Overall Study | Adverse Event | 43 |
| Overall Study | Lack of Efficacy | 19 |
| Overall Study | Lost to Follow-up | 23 |
| Overall Study | Withdrawal by Subject | 31 |
Baseline characteristics
| Characteristic | Total BTDS 5, 10, 20 |
|---|---|
| Age Continuous | 51.2 years STANDARD_DEVIATION 12.47 |
| Sex: Female, Male Female | 157 Participants |
| Sex: Female, Male Male | 197 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 153 / 354 |
| serious Total, serious adverse events | 20 / 354 |
Outcome results
Primary
Number of Participants With Adverse Events (AEs) as a Measure of Safety
The purpose of the extension phase was to evaluate the long-term safety and tolerability of BTDS in subjects who had participated in the core study (BUP3015).
Time frame: 52-week extension phase
Population: The Extension Safety Population (N = 354) 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) |
|---|---|---|---|
| Total BTDS 5, 10, 20 | Number of Participants With Adverse Events (AEs) as a Measure of Safety | Death | 1 participants |
| Total BTDS 5, 10, 20 | Number of Participants With Adverse Events (AEs) as a Measure of Safety | Serious adverse events | 20 participants |
| Total BTDS 5, 10, 20 | Number of Participants With Adverse Events (AEs) as a Measure of Safety | All other adverse events in ≥ 4.5% of subjects | 153 participants |