Efficacy of Etoricoxib 60 mg in Modifying Pain Hypersensitivity in People With Knee Osteoarthritis

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to better understand the way in which painful osteoarthritis affects different people and whether an anti-inflammatory medication such as Arcoxia (etoricoxib) can help to modify this pain. The study will use questionnaires and tests of pain sensitivity to identify arthritis sufferers with more widespread, nerve-type pain and then to investigate whether a daily dose of Arcoxia is more effective than a placebo pill in reducing these symptoms and improving functional movements. The study will also be comparing the same test results of a small group of subjects without knee pain.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Curtin University; Curtin University of Technology
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Etoricoxib

Criteria

Inclusion Criteria:

• unilateral diagnosis of Knee OA > 6 months

• knee pain > 4/10 on WOMAC pain subscale

• if pain in contralateral knee, no greater than "mild"

• no other significant joint involvement

• ARA functional Class I, II or III

• no arthroscopy or injections into index knee in last 6 months

Exclusion Criteria:

• history of systemic inflammatory or chronic pain disorders (especially fibromyalgia)

• neurological deficit

• recent (< 6 months) lower limb surgery

• allergic reaction to NSAIDs or aspirin

• skin allergies, dermatitis

• contraindications to Cox-2 inhibitors:

• congestive heart failure (NYHA II-IV)

• unstable hypertension

• ischaemic heart disease

• peripheral artery disease

• cerebrovascular disease including CABG or angioplasty within 1 year

• severe hepatic dysfunction

• active GI bleeding or peptic ulceration

• reduced creatinine clearance < 30 mL/min

• current use of high dose (> 325 mg daily) aspirin