A Phase 3 interventional study of Buprenorphine transdermal delivery system in Osteoarthritis, sponsored by Purdue Pharma LP. Completed at 22 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2006-05-03.
Sponsored by Purdue Pharma LP · Phase 3, Interventional, and Treatment
The objective of this study is to assess the safety and efficacy of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system in subjects with osteoarthritis pain. The double-blind treatment intervention duration is 28 days.
Buprenorphine is a synthetic opioid analgesic with over twenty-five years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain. Transdermal systems may offer advantages over currently indicated oral products including ease and convenience of use, improved compliance, possible reduction in patient care, and prolonged and consistent delivery of drug.
4,399 studies on the registry are indexed under Osteoarthritis; 583 are open to participants now.
This study's enrollment of 260 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Purdue Pharma LP is the lead sponsor of 58 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other protocol-specific exclusion/inclusion criteria may apply.
Percentage of patients who were treated successfully for pain management
a patient fails if he or she discontinues early due to ineffective treatment or has a Patient Satisfaction Scale score of poor or fair at the final visit
Average pain intensity and patient satisfaction scores
Incidence of early discontinuation due to lack of efficacy
Time to early discontinuation due to lack of efficacy
Dose level at end of titration
Investigator's assessment of therapeutic response
Diary pain scores
This study is completed, as verified in Apr 2006. You cannot join it, but the record below documents what was studied.
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Purdue Pharma LP