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Norspan vs Tramadol in Osteoarthritis Pain
NCT00426647Phase 4
Key facts
- Status
- Completed
- Start
- Feb 2007
- Primary completion
- Jul 2009
- Countries
- 1
- Sponsor
- Norpharma
- Modality
- Orthosteric Ligands
- Drugs
- buprenorphine
- Conditions
- osteoarthritis (OA)
01
Overview
Phase 4, randomised, double-blind trial of buprenorphine in osteoarthritis (OA) (2 arms), sponsored by Norpharma. Primary endpoint: Efficacy of Norspan patches versus Tramadol. Started Feb 2007; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Buprenorphine Arm
Norspan transdermal patch
Tramadol Arm
Tramadol SR tablets
03
Who it enrols
Adults (18+ for hip/knee, 50+ for lumbar spine) with moderate to severe osteoarthritis pain who were not adequately relieved by paracetamol 4000 mg/day or equivalent.
04
Endpoints
Primary
Efficacy of Norspan patches versus Tramadol
Secondary
Safety and general satisfaction
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