Phase 3
N=567
Buprenorphine Transdermal System (BTDS) in Subjects w/Mod-sev Osteoarthritis (OA) Chronic Pain of Knee
Chronic Pain · Osteoarthritis of the Knee
Bottom Line
View on ClinicalTrials.gov: NCT00531427 ↗Enrolled (actual)
567
Serious AEs
1.2%
Results posted
Sep 2010
Primary outcome: Primary: "Average Pain Over the Last 24 Hours" Score of the Study Knee at Week 12 of the Double Blind Phase. — 7.16; 7.06; 2.63; 2.74 units on a scale — p=0.0853
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Buprenorphine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Purdue Pharma LP
- Primary completion
- Apr 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY "Average Pain Over the Last 24 Hours" Score of the Study Knee at Week 12 of the Double Blind Phase. |
7.16; 7.06; 2.63; 2.74; 3.82; 4.22 | 0.0853 |
| SECONDARY Mean Daily Number of Tablets of Nonopioid Supplemental Analgesic Used From Week 2 to 12 of the Double-blind Phase. |
0.701; 0.740 | 0.7098 |
| SECONDARY Sleep Disturbance Subscale of the MOS-Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase. |
49.51; 51.23; 23.23; 26.04; 27.22; 35.08 | 0.0034 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 pain due to osteoarthritis (OA) of the knee. The double-blind treatment intervention duration is 12 weeks, during which time supplemental analgesic medication (immediate-release oxycodone for the first 6 days postrandomization 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 osteoarthritis (OA) pain of the knee (lasting several hours daily) as their predominant pain condition,
- clinical diagnosis of OA of the knee 1 year or longer,
- 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 OA knee pain is not adequately controlled with nonopioid analgesic medication and who the investigator feels are appropriate candidates for around-the-clock opioid therapy.
Exclusion Criteria
- subjects who have had arthroscopy on either knee or hip within 6 months of entering the study or open surgery on either knee or hip within 9 months of entering the study,
- subjects who are allergic to buprenorphine or who have 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 (NCT00531427). 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.