Phase 4 N=219 Randomized Treatment

Buprenorphine in the Treatment of Osteoarthritis (OA) in the Elderly

Osteoarthritis

Bottom Line

View on ClinicalTrials.gov: NCT00324038 ↗

Enrolled (actual)

219

Serious AEs

—

Results posted

Mar 2010

Primary outcome: Primary: Average Daily Pain Scores - BS11 Pain Scores. — 3; 3 Box Scale 11 boxes

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Buprenorphine (Drug); Codeine paracetamol (Drug)
Age: Older Adult · 65+ yrs
Sex: All
Sponsor: Napp Pharmaceuticals Limited
Primary completion: —

Outcome Measures

Outcome	Result	p-value
PRIMARY Average Daily Pain Scores - BS11 Pain Scores.	3; 3	—

Summary

The primary objective is to compare buprenorphine transdermal delivery system (BTDS) with standard- treatment in subjects with osteoarthritis (OA).

Eligibility Criteria

Inclusion Criteria

Either sex aged 65 or above
Diagnosis of OA of the hip and/or knee
Severe pain requiring step two medication
Taking maximum dose of paracetamol

Exclusion Criteria

Painful disease of the joints other than OA
Contraindication to buprenorphine, other opioids, patch adhesives or nonsteroidal anti-inflammatory agents (NSAIDS)
Subjects taking cyclooxygenase (COX) II selective inhibitors

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00324038). 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.