- The clinical diagnosis of osteoarthritis of the hand, of at least 6 months duration.
- Pain around one of the thumb joints due to osteoarthritis. The patient must report the
average pain in this joint, in the week prior to screening, as at least 5 on an
11-point numerical pain rating scale at the time of screening.
- The patient must demonstrate pressure pain at a thumb joint by reporting a pressure
pain threshold lower than 300 kPa.
- Pregnant (as judged by a urine pregnancy test) or lactating female.
- Other severe pain which may impair the assessment of the pain due to osteoarthritis.
- Skin condition over the thumb joint, which will be used for pain threshold testing,
that could interfere with the assessment of pain thresholds.
- Known hypersensitivity to oxycodone, NSAIDS or tramadol.
- Patients in whom NSAIDS, oxycodone or tramadol are contraindicated, or patients taking
any concurrent medications which are contraindicated with any of the study medications
.
- An estimated renal clearance of less than 30 mL/min based on the Cockcroft Gault
equation.
- Use of prohibited medications as listed below, in the absence of appropriate washout
periods:
- Oral or intramuscular corticosteroids within 4 weeks prior to screening.
- Monoamine oxidase inhibitors within 2 weeks of screening.
- Analgesic agents, other than aspirin, or acetaminophen within 1 week prior to
screening. (Aspirin use less than or equal to 325 mg per day for cardiovascular
prophylaxis is permitted)
- Acetaminophen up to 4 g/day may be used, provided it is not used in the 24 hours prior
to any assessment of pain thresholds.
- Intra-articular steroid injections into the study joint within 12 weeks, or to any
other joint within 4 weeks, prior to screening.
- History of chronic constipation, or of any condition which, in the opinion of the
investigator, may put the patient at increased risk of respiratory depression.