Phase 3
N=134
The Safety and Efficacy of the Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Back Pain.
Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT00315445 ↗Enrolled (actual)
134
Serious AEs
6.0%
Results posted
Aug 2011
Primary outcome: Primary: Pain on the Average, Mean Change From Baseline Days 21-84 (Last Observation Carried Forward [LOCF]) — -1.01; -1.82; -1.92 Units on a scale — p=0.0350
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Buprenorphine transdermal patch (Drug); Placebo oxycodone/acetaminophen tablets (Drug); OXY/APAP (Drug); Placebo transdermal patch (TDS) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Purdue Pharma LP
- Primary completion
- May 1998
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain on the Average, Mean Change From Baseline Days 21-84 (Last Observation Carried Forward [LOCF]) |
-1.01; -1.82; -1.92 | 0.0350 sig |
| PRIMARY Pain Right Now, Mean Change From Baseline, Days 21-84 (LOCF) |
-0.80; -1.53; -1.66 | 0.0452 sig |
| SECONDARY "Physical Functioning" Scale of the Medical Outcomes Survey (MOS) 36 Item Short-Form Health Survey (SF-36): Mean Percent ± Standard Error of the Mean (SEM) at Day 84 (LOCF) |
46.4; 44.5; 46.5 | — |
| SECONDARY "Physical Role" Scale (MOS SF-36): Mean Percent ± SEM at Day 84(LOCF) |
18.9; 24.4; 33.9 | — |
| SECONDARY "Bodily Pain" (MOS SF-36): Mean Percent at Day 84 (LOCF) |
35.3; 39.0; 41.9 | — |
| SECONDARY "General Health" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF) |
52.4; 52.5; 57.7 | — |
| SECONDARY "Vitality" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF) |
39.0; 42.9; 41.2 | — |
| SECONDARY "Social Functioning" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF) |
53.3; 59.5; 65.2 | — |
| SECONDARY "Emotional Role" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF) |
55.3; 56.3; 63.0 | — |
| SECONDARY "Mental Health" (MOS SF-36):Mean Percent ± SEM at Day 84 (LOCF) |
67.4; 68.8; 67.8 | — |
| SECONDARY Therapeutic Response - Investigator: Mean ± SEM (Day 84)(LOCF) |
1.1; 2.0; 1.9 | — |
| SECONDARY Therapeutic Response - Subject: Mean ± SEM (Day 84) (LOCF) |
1.1; 2.1; 2.0 | — |
| SECONDARY Subject Comparison to Prestudy Analgesic: Mean ± SEM (Day 84)(LOCF) |
0.9; 1.4; 1.4 | — |
| SECONDARY Subject Satisfaction: Mean ± SEM (Day 84)(LOCF) |
2.2; 1.8; 1.7 | — |
| SECONDARY Time to Stable Pain Management |
14; 7; 7 | 0.054 |
| SECONDARY The Time to Discontinuation Due to Lack of Efficacy |
NA; NA; NA | 0.0105 sig |
Summary
The objective of this study is to assess the safety of the buprenorphine transdermal system (5, 10, and 20) in comparison to placebo transdermal system and immediate release oxycodone/ acetaminophen in subjects with chronic back pain. The double-blind treatment intervention duration is 84 days during which time supplemental analgesic medication (non-steroidal anti-inflammatory drugs) will be allowed for all subjects in addition to study drug.
Eligibility Criteria
Inclusion Criteria
- clinical evidence of stable, chronic (>2 months) back pain related to intervertebral disc disease, nerve root entrapment, spondylolithesis, and osteoarthritis or other, similar nonmalignant conditions.
- unacceptable pain control despite currently taking a nonsteroidal anti-inflammatory drug considered at a therapeutic and/or tolerated dose or, subjects currently taking 90 mg of oral morphine equivalents or receiving more than 12 tablets per day of short-acting opioid-containing products.
- scheduled to have surgery (including dental) involving the use of preoperative or postoperative analgesics or anesthetics during the study period.
Other protocol-specific exclusion/inclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00315445). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.