A Randomised Open Controlled Parallel Group Study Comparing Norspan and Tramadol
Phase 4
Completed
- Conditions
- Osteoarthritis
- Registration Number
- NCT00399178
- Lead Sponsor
- Mundipharma AB
- Brief Summary
To evaluate the efficacy and safety of Norspan versus Tiperol Retard among OA patients who are sub-optimally treated with current analgesic. Those patients may benefit from treatment with a long lasting analgesic.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
Inclusion Criteria
- OA diagnosis
- BS11 greater than or equal to 4 at base line
- Not adequately pain relieved with 4,000 mg paracetamol daily
Exclusion Criteria
- Treated with high potent opioids for their OA pain
- Treated with a regular dose for greater than one week of Tramadol, Codeine or dextropropoxifene during the last three months
- Other chronic conditions requiring frequent analgesic therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Dr Mats Karlsson
🇸🇪Falkoping, Parkgatan 6C, Sweden