Phase 3
N=1,024
Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Chronic Low Back Pain
Low Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT00490919 ↗Enrolled (actual)
1,024
Serious AEs
0.6%
Results posted
Sep 2010
Primary outcome: Primary: Average Pain Over the Last 24 Hours Scores at Week 12 of the Double-blind Phase. — 7.24; 7.17; 2.57; 2.56 Units on a scale — p=.0104
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Buprenorphine transdermal system (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Purdue Pharma LP
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Pain Over the Last 24 Hours Scores at Week 12 of the Double-blind Phase. |
7.24; 7.17; 2.57; 2.56; 3.83; 4.38 | .0104 sig |
| SECONDARY The Mean Daily Number of Tablets of Nonopioid Supplemental Analgesic Medications Taken During Weeks 2 Through 12 of the Double-blind Phase |
0.620; 0.743 | .1586 |
| SECONDARY The Sleep Disturbance Subscale in the Medical Outcome Study (MOS) Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase |
32.84; 41.20; 35.63; 39.87; 34.97; 40.42 | .0062 sig |
Summary
The objective of this study is to determine the analgesic efficacy and safety of Buprenorphine Transdermal System (BTDS) 10 and 20 compared to placebo in opioid-naïve subjects with moderate to severe chronic low back pain. The double-blind treatment intervention duration is 12 weeks, during which time supplemental analgesic medication (immediate-release oxycodone for the first 6 days post-randomization and acetaminophen or ibuprofen for the remainder of the double-blind phase) will be provided to all subjects in addition to study drug.
Eligibility Criteria
Inclusion Criteria
- Subjects with moderate to severe chronic low back pain (lasting several hours daily) as their predominant pain condition for at least 3 months prior to screening,
- Subjects treated within the 14 days prior to screening with nonopioid therapy only, or with therapy including opioids at a dose of <5 mg oxycodone (or equivalent) per day,
- Subjects whose low back pain is not adequately controlled with non-opioid analgesic medication and who the Investigator feels are appropriate candidates for around-the-clock opioid therapy
Exclusion Criteria
- Subjects who had a surgical procedure directed towards the source of back pain within 6 months of screening or planned during the study conduct period,
- Subjects who are allergic to buprenorphine or who had a history of allergies to other opioids,
- Subjects who have allergies or other contraindications to transdermal delivery systems or patch adhesives.
Other protocol-specific inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00490919). 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.