Norspan® Patches Versus Tramadol in Subjects With Chronic, Moderate to Severe Osteoarthritis Pain… (NCT00426647) | Clinical Trial Compass
CompletedPhase 4
Norspan® Patches Versus Tramadol in Subjects With Chronic, Moderate to Severe Osteoarthritis Pain in the Hip Knee and/or Lumbar Spine
Finland120 participantsStarted 2007-02
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
âś“. 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 \&/or knee.
âś“. Clinical diagnosis of OA in the hip and/or knee including fulfilment of ACR-criteria and radiographic or MR-Scan evidence for the primary OA-joint in hip \&/or knee.
âś“. 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/Visit 4).
âś“. 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.
âś“. 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).
âś“. Subjects must be able to read and comprehend Danish and be willing to sign informed consent.
âś“. Subjects must be willing and able to fill in a Subject Diary on a daily basis.
Exclusion criteria
✕. Subjects treated with high-potent opioid analgesics (e.g. morphine, fentanyl, oxycodone, methadone, hydromorphone, ketobemidone, buprenorphine (incl. Norspan® patches)) 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.
What they're measuring
1
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.
✕. Subjects treated with high-potent opioid analgesics (e.g. morphine, fentanyl, oxycodone, methadone, hydromorphone, ketobemidone, buprenorphine (incl. Norspan® patches)) within four weeks prior to the Pre-screening Visit due to non-OA pain.
âś•. 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.
âś•. 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.
âś•. 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.
âś•. Substance or alcohol abuse, or subjects who, in the opinion of the Investigator, have demonstrated addictive or substance abuse behaviour.
âś•. Subjects with cancer (except basal cell carcinoma) or history of cancer in the last 5 years (except treated basal cell carcinoma).
âś•. Untreated depression or other psychiatric disorder in such a way that participation in the study may, in the opinion of the Investigator, pose an unacceptable risk to the subject.