Chronic Nonmalignant Pain
Conditions
Keywords
Chronic nonmalignant pain, Opioid, Transdermal, Butrans (BTDS)
Brief summary
The objective of this study was to evaluate the long-term safety and tolerability of 7-day BTDS in a 28-week open-label extension phase in subjects with chronic nonmalignant pain syndromes whose pain had been previously controlled by oral opioid combination therapy.
Detailed description
Upon entering the extension phase (BUP3201S), subjects will receive BTDS 5, regardless of their dose level at discontinuation or completion of the BUP3201 core study. Subjects are allowed to titrate after 48 hours to BTDS 10 or 20 that provided stable pain control with minimal tolerability problems. Additional medical therapies are permitted if necessary, and there is no restriction on concomitant analgesic medications. The subjects have weekly visits for 4 consecutive weeks, and every 4 weeks thereafter, until the end of the scheduled extension phase.
Interventions
Buprenorphine transdermal patch 5, 10 or 20 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
Include: * Subjects of either sex aged 18 years or older. * Subjects who have completed or discontinued the double-blind evaluation phase of study BUP3201 are eligible to continue to receive open-label BTDS in the extension.
Exclusion criteria
Include: * Subjects currently receiving daily morphine or oxycodone (mono-therapy). * Subjects who are discontinued from BUP3201 due to adverse events. * Subjects who are scheduled for surgery of the disease site (e.g. major joint replacement surgery) or any other major surgery which would fall within the study period. Refer to core study for additional inclusion/exclusion information.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) as a Measure of Safety. | 28 weeks | Safety was assessed using reports of all new adverse events (AEs) that occurred after the first application of a patch during the extension phase were recorded. |
Countries
United States
Participant flow
Recruitment details
16-Apr-2001 (first patient first visit) 27-Feb-2002 (last patient last visit). The extension phase of study was conducted at 20 sites in the US Baseline Period: and 18 sites in the UK.
Pre-assignment details
Adult subjects aged ≥ 18 years, with chronic nonmalignant pain, controlled on oral opioid therapy. Subjects in the US who participated in the BUP3201 core study and met the criteria per Amendment 2, and subjects in the UK who participated in the BUP3201 core and met the inclusion/ exclusion criteria, were able to participate in the extension.
Participants by arm
| Arm | Count |
|---|---|
| Extension Phase (BTDS 5, 10 or 20) Buprenorphine transdermal patches (BTDS 5, 10 or 20) applied for 7-day wear. | 189 |
| Total | 189 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 82 |
| Overall Study | Lack of Efficacy | 15 |
| Overall Study | Lost to Follow-up | 6 |
| Overall Study | Miscellaneous | 13 |
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | Extension Phase (BTDS 5, 10 or 20) |
|---|---|
| Age Continuous | 55.2 years STANDARD_DEVIATION 12.84 |
| Region of Enrollment United Kingdom | 86 participants |
| Region of Enrollment United States | 103 participants |
| Sex: Female, Male Female | 118 Participants |
| Sex: Female, Male Male | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 143 / 189 |
| serious Total, serious adverse events | 16 / 189 |
Outcome results
Primary
Number of Participants With Adverse Events (AEs) as a Measure of Safety.
Safety was assessed using reports of all new adverse events (AEs) that occurred after the first application of a patch during the extension phase were recorded.
Time frame: 28 weeks
Population: The Extension Safety population (N = 189) includes all subjects who were exposed to BTDS during the Open-label Extension Phase and provided at least 1 valid safety assessment after exposure to BTDS during the Open-label Extension Phase.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Total Extension Phase | Number of Participants With Adverse Events (AEs) as a Measure of Safety. | Deaths | 1 participants |
| Total Extension Phase | Number of Participants With Adverse Events (AEs) as a Measure of Safety. | Serious Adverse Events | 16 participants |
| Total Extension Phase | Number of Participants With Adverse Events (AEs) as a Measure of Safety. | All Other Adverse Events in ≥ 4.5% of Subjects | 143 participants |