Phase 3
N=267
Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Nonmalignant Pain
Chronic Non-malignant Pain
Bottom Line
View on ClinicalTrials.gov: NCT00312195 ↗Enrolled (actual)
267
Serious AEs
0.8%
Results posted
Oct 2010
Primary outcome: Primary: The Number of Subjects With Ineffective Treatment During the Double-blind Evaluation Phase. — 89; 66; 155; 81 participants — p=.0217
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Buprenorphine transdermal patch (Drug); Placebo to match BTDS (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Purdue Pharma LP
- Primary completion
- Jul 2001
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Subjects With Ineffective Treatment During the Double-blind Evaluation Phase. |
89; 66; 155; 81; 59; 140 | .0217 sig |
| SECONDARY Time (Days) From the Initial Dose of Study Drug in the Double-blind Evaluation Phase to Ineffective Treatment |
5.6; 7.4 | — |
| SECONDARY The Number of Subjects Who Had Ineffective Treatment or Who Discontinued Due to Reasons Other Than Ineffective Treatment in the Double-blind Phase |
93; 71; 89; 66; 5; 6 | — |
| SECONDARY The Amount of Rescue Medication Used for Pain (Average Daily Number of Acetaminophen Tablets). |
2.2; 1.8 | — |
Summary
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (5, 10 and 20) in comparison to matching placebo transdermal system in subjects with chronic nonmalignant pain syndromes currently controlled by oral opioids. The double-blind treatment intervention duration is 2 weeks during which time supplemental analgesic medication (acetaminophen) will be provided to all subjects in addition to study drug.
Eligibility Criteria
Inclusion Criteria
- At least 2 month's history of nonmalignant pain, currently in stable pain control on opioid therapy.
- Good, very good or excellent pain control on current opioid therapy.
- Willing and able to use a telephone interactive voice response service.
Exclusion Criteria
- Currently receiving daily morphine or oxycodone monotherapy.
- Scheduled for surgery of the disease site (eg, major joint replacement surgery), or any other major surgery, which would fall within the study period.
Other protocol-specific exclusion/inclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00312195). 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.