Osteoarthritis
Conditions
Keywords
Osteoarthritis, Norspan versus Tramadol, Randomised, Efficacy and safety, OA pain of the hip and/or knee
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.
Interventions
DRUGTransdermal delivery system
Sponsors
Mundipharma AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Sweden
Outcome results
None listed