Phase 3
Completed N=134
The Safety and Efficacy of the Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Back Pain.
Back Pain
Source: ClinicalTrials.gov NCT00315445 ↗
Enrolled (actual)
134
Serious AEs
6.0%
Results posted
Aug 2011
Primary outcomePrimary: 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
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.
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 |
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. Informational only — not medical advice.