Norspan® Patches Versus Tramadol in Subjects With Chronic, Moderate to Severe Osteoarthritis Pain in the Hip Knee and/or Lumbar Spine
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|ClinicalTrials.gov Identifier: NCT00426647|
Recruitment Status : Completed
First Posted : January 25, 2007
Last Update Posted : February 1, 2010
The primary objective of this equivalence study is to evaluate the efficacy of Norspan® patches versus Tramadol in subjects with chronic, moderate to severe osteoarthritis pain of the hip, knee and/or lumbar spine.
The secondary objectives are to evaluate the safety and general satisfaction for the patients in the two treatment groups.
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis Pain||Drug: Buprenorphine Drug: Tramadol||Phase 4|
This is a randomised, double-blind, multicentre equivalence study with active comparator, parallel group, to evaluate the efficacy and safety of Norspan® patches versus Tramadol in subjects with OA pain in hip, knee and/or lumbar spine, currently receiving sub-optimal analgesic treatment (defined as BS-11 score > 4) when treated with paracetamol 4000 mg/day or another analgesic at least comparable to this.
The study consist of 4 phases:
Run-in, Wash-out, Double blind and Follow-up
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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.|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||August 2009|
Norspan transdermal patch
Active Comparator: Tramadol
Tramadol SR tablets
- Equivalence study to evaluate the efficacy of Norspan® patches versus Tramadol in subjects with chronic, moderate to severe osteoarthritis pain of the hip, knee and/or lumber spine.
- To evaluate the safety and general satisfaction for the patients in the two treatment groups.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00426647
|Dr. Olavi Airaksinen|
|Oma Lääkäri Oy, Vuorikatu 20, Kuopio, Finland, FIN-70100|
|Study Director:||Dorthe Tvinnemose, DVM||Norpharma A/S, Slotsmarken 15, DK-2970 Hoersholm, Denmark|
|Principal Investigator:||Kim H Kristiansen, DM||GP, Noerretorv 10, DK-7200 Grindsted, Denmark|
|Principal Investigator:||Olavi Airaksinen, DM||Oma Lääkäri Oy, Vuorikatu 20, FIN-70100 KUOPIO|