Status:
COMPLETED
Efficacy of Etoricoxib 60 mg in Modifying Pain Hypersensitivity in People With Knee Osteoarthritis
Lead Sponsor:
Curtin University
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Osteoarthritis
Pain
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief 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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00927004
Start Date
August 1 2010
End Date
December 1 2011
Last Update
May 3 2012
Active Locations (1)
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1
Royal Perth Hospital
Perth, Western Australia, Australia, 6000