Efficacy of Etoricoxib 60 mg in Modifying Pain Hypersensitivity in People With Knee Osteoarthritis
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.
3 other identifiers
interventional
80
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Aug 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2009
CompletedFirst Posted
Study publicly available on registry
June 24, 2009
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedMay 3, 2012
May 1, 2012
1.3 years
June 23, 2009
May 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Pressure Pain Threshold
15 days, 3 days
Western Ontario and McMaster University Osteoarthritis Index (knee) - pain subscale
15 days, 3 days
Secondary Outcomes (7)
Cold Pain Threshold
15 days, 3 days
Topical Cold Response
15 days, 3 days
Functional Measure (aggregated locomotor score, sit-to-stand time)
15 days, 3 days
WOMAC (knee) total
15 days, 3 days
SF-36v2
15 days, 3 days
- +2 more secondary outcomes
Study Arms (2)
Etoricoxib 60 mg
EXPERIMENTALSugar pill
PLACEBO COMPARATORInterventions
60 mg, daily dose, oral delivery, 14 days duration
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Curtin Universitylead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (1)
Royal Perth Hospital
Perth, Western Australia, 6000, Australia
Related Publications (1)
Moss P, Benson HAE, Will R, Wright A. Fourteen days of etoricoxib 60 mg improves pain, hyperalgesia and physical function in individuals with knee osteoarthritis: a randomized controlled trial. Osteoarthritis Cartilage. 2017 Nov;25(11):1781-1791. doi: 10.1016/j.joca.2017.07.009. Epub 2017 Aug 2.
PMID: 28778815DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tony Wright, PhD
Curtin University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer
Study Record Dates
First Submitted
June 23, 2009
First Posted
June 24, 2009
Study Start
August 1, 2010
Primary Completion
November 1, 2011
Study Completion
December 1, 2011
Last Updated
May 3, 2012
Record last verified: 2012-05