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

Curtin University

Status and phase

Completed

Phase 4

Conditions

Osteoarthritis

Pain

Treatments

Drug: Etoricoxib (Arcoxia)

Drug: Sugar pill

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00927004

3144 Wright-Merck

HR47-2009

Moss IISP#36409

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

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