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

Pain Clinical Trial

Official title:

A Randomised Placebo-controlled Trail of Mechanical and Cold Hyperalgesia in Subjects With Painful Knee Osteoarthritis, Compared With Matched Controls, & Whether This Hyperalgesia Can be Modified by a 2-week Course of Etoricoxib 60mg.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00927004
• Other study ID #: Moss IISP#36409
• Secondary ID: 3144 Wright-Merc
• Status: Completed
• Phase: Phase 4
• First received: June 23, 2009
• Last updated: May 1, 2012
• Start date: August 2010
• Est. completion date: December 2011

Study information

• Verified date: May 2012
• Source: Curtin University of Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research CouncilAustralia: Department of Health and Ageing Therapeutic Goods AdministrationAustralia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperalgesia
• Osteoarthritis
• Osteoarthritis, Knee
• Pain

Intervention

Drug:
• Etoricoxib (Arcoxia)
60 mg, daily dose, oral delivery, 14 days duration
• Sugar pill
Daily dose (1 pill), oral delivery, 14 days

Locations

Country	Name	City	State
Australia	Royal Perth Hospital	Perth	Western Australia

Sponsors (2)

Lead Sponsor	Collaborator
Curtin University of Technology	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pressure Pain Threshold		15 days, 3 days	No
Primary	Western Ontario and McMaster University Osteoarthritis Index (knee) - pain subscale		15 days, 3 days	No
Secondary	Cold Pain Threshold		15 days, 3 days	No
Secondary	Topical Cold Response		15 days, 3 days	No
Secondary	Functional Measure (aggregated locomotor score, sit-to-stand time)		15 days, 3 days	No
Secondary	WOMAC (knee) total		15 days, 3 days	No
Secondary	SF-36v2		15 days, 3 days	No
Secondary	Pain Quality Assessment Scale		15 days, 3 days	No
Secondary	PainDETECT questionnaire		15 days, 3 days	No

External Links

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