A Randomised Open Controlled Parallel Group Study Comparing Norspan and Tramadol
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|ClinicalTrials.gov Identifier: NCT00399178|
Recruitment Status : Completed
First Posted : November 14, 2006
Last Update Posted : August 17, 2007
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis||Drug: Transdermal delivery system||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomised Open Controlled Parallel Group Multicenter Study to Evaluate the Efficacy and Safety of Norspan Versus Tiparol Retard in Subjects With Chronic Moderate to Severe OA Pain of the Hip and/or Knee.|
|Study Start Date :||November 2006|
|Actual Study Completion Date :||June 2007|
- Box Scale 11 pain scores for pain on average during the last week then mean change from base line to completion. BS11 is recorded daily by the patients in a diary.
- Rescue medication recorded daily by patients. Sleep disturbance and quality of sleep. Patients global assessment of pain relief, investigators global assessment of pain relief, patients preference, WOMAC OA index, EuroQoL EQ-5D.
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): NCT00399178
|Dr Mats Karlsson|
|Falkoping, Parkgatan 6C, Sweden, 521 43|
|Principal Investigator:||M Karlsson, Med|