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. 2019 May 27;2019(5):CD005522. doi: 10.1002/14651858.CD005522.pub3

NCT00426647.

Methods Official title: a randomised double‐blind multicentre equivalence study with active parallel comparator group to evaluate the efficacy and safety of Norspan® patches versus tramadol in subjects with chronic, moderate to severe osteoarthritis pain in the hip, knee &/or lumbar spine.
Randomized, double‐blind, multicenter equivalence study with active comparator, parallel group, to evaluate the efficacy and safety of Norspan® patches vs tramadol in people with OA pain in hip, knee, lumbar spine, or a combination of these, currently receiving suboptimal analgesic treatment (defined as BS‐11 score > 4) when treated with acetaminophen 4000 mg/day or another analgesic at least comparable to this.
4 phases: run‐in, washout, double‐blind and follow‐up
Participants Diagnosed with OA pain in hip, knee, lumbar spine, or a combination of these and aged ≥ 18 years.
Interventions Tramadol
Buprenorphine
Outcomes Major outcome: efficacy of Norspan®
Minor outcome: safety and general satisfaction
Notes Study start date: February 2007
Primary completion date: July 2009
Study completion date: August 2009
Contact information:
Address: GP, Noerretorv 10, DK‐7200 Grindsted, Denmark, Olavi, Airaksinen DM (principal investigator), Oma Lääkäri Oy, Vuorikatu 20, FIN‐70100 KUOPIO
Email: olavi.airaksinen@kuh.fi
Email: norpharma@norpharma.dk
ClinicalTrials.gov identifier: NCT00426647