Chronic, moderate to severe osteoarthritis in hip, knee and/or lumbar spine
Conditions
Interventions
Trade Name: Norspan 5, 10, 20 microgram/hour
Product Name: Norspan
Pharmaceutical Form: Transdermal patch
Pharmaceutical form of the placebo: Transdermal patch
Route of administration of the placebo:
Sponsors
Norpharma A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females aged 18 years or more (women of childbearing potential must have a negative pregnancy test, be non-lactating, and willing to use adequate and reliable contraception (defined as IUD, contraceptive pill or depot gestagen) throughout the study) with osteoarthritis in the hip and/or knee. or Males and females aged 50 years or more with osteoarthritis in lumbar vertebrae without nerve root pressure. 2. Clinical diagnosis of OA in the hip and/or knee including fulfillment of ACR-criteria and radiographic or MR-scan evidence for the primary OA-joint in hip and/or knee. or Clinical diagnosis of OA in the lumbar vertebrae without nerve root pressure, and with radiographic or CT-scan evidence for lumbar OA. 3. Subjects with moderate to severe pain confirmed by a BS-11 score > 4 for their pain on average in their primary OA-joint during the last 5 days prior to the Baseline Visit (Randomisation Visit). 4. Subjects must previously or during Wash-out-Phase have been treated with 4000 mg Paracetamol IR daily or another analgesic treatment at least comparable to this and not have been adequately pain relieved (defined as BS-11 score > 4 for their pain on average in their Primary OA-joint during 5 continuous days) on that treatment. 5. Subjects must be willing to discontinue all other analgesics (incl. glucosamine) at the Pre-Screening Visit (Visit 1) and until the Completion/Discontinuation Visit (Visit 10). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects treated with high-potent opioid analgesics (e.g. morphine, fentanyl, oxycodone, methadone, hydromorphone, ketobemidone, buprenorphine (incl. Norspan®)) for their OA pain. Except subjects treated with high-potent opioid analgesics for up to four continuous weeks for their OA pain beyond 3 months prior to the Pre-screening Visit. 2. Subjects treated with high-potent opioid analgesics (e.g. morphine, fentanyl, oxycodone, methadone, hydromorphone, ketobemidone, buprenorphine (incl. Norspan®)) within four weeks prior to the Pre-screening Visit due to non-OA pain. 3. Subjects treated with more than 200 mg Tramadol daily or 200 mg codeine daily during the last two weeks prior to the Pre-screening Visit. 4. History of chronic condition(s), in addition to OA, requiring frequent analgesic therapy (e.g. frequent headaches, frequent migraine, gout, rheumatoid arthritis) and severe respiratory disease. 5. Scheduled for surgery that would fall within all phases (Run-in-Phase, Wash-out-Phase, Double-Blind-Phase and Follow-up-Phase) of the study. 6. Substance or alcohol abuse, or subjects who, in the opinion of the Investigator, have demonstrated addictive or substance abuse behaviour.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this non-inferiority study is to evaluate the efficacy of Norspan® versus Tramadol in subjects with chronic, moderate to severe osteoarthritis pain of the hip, knee and/or lumbar spine.;Secondary Objective: The secondary objective is to evaluate the safety for the patients in the two treatment groups.;Primary end point(s): Box Scale-11 (BS-11) pain scores (pain on average in the primary OA-joint during the last 5 days), mean change from Baseline to Completion (fulfilled all visits in the study). | — |
Countries
Denmark, Finland
Outcome results
None listed