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Trial registered on ANZCTR


Registration number
ACTRN12609000524291
Ethics application status
Not yet submitted
Date submitted
22/06/2009
Date registered
1/07/2009
Date last updated
1/07/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Do people with painful knee osteoarthritis have greater pain sensitivity than similar aged healthy people, and can this pain sensitivity be altered by a 2-week course of the anti-inflammatory Arcoxia?
Scientific title
Do subjects with symptomatic knee osteoarthritis demonstrate more widespread mechanical and cold hyperalgesia compared with matched controls, and can this hyperalgesia be better modified by a 2-week course of Arcoxia than placebo?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
osteoarthritis 237075 0
chronic pain 237076 0
Condition category
Condition code
Musculoskeletal 237396 237396 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
etoricoxib 60mg (oral) daily, 14 day intervention
Intervention code [1] 236796 0
Treatment: Drugs
Comparator / control treatment
placebo (60mg sugar pill) oral daily, 14 day course
Control group
Placebo

Outcomes
Primary outcome [1] 238196 0
Pressure Pain Threshold, assessed using an electronic algometer (Somedic, AB), 1cm square tip, applied at 90 degrees to test site at a rate of 40kPa/sec. Subjects press switch to record pressure when pain is first perceived.
Timepoint [1] 238196 0
Primary Timepoint: 2 weeks post start of intervention (15th day)
Secondary Timepoint (analysed if Primary Timepoint significant): 2 days post start of intervention
Primary outcome [2] 238197 0
Western Ontario and McMaster University Osteoarthritis Index (knee) (WOMAC) - pain subscale
Timepoint [2] 238197 0
Primary Timepoint: 2 weeks post start of intervention (15th day)
Secondary Timepoint (analysed if Primary Timepoint significant): 2 days post start of intervention
Secondary outcome [1] 244594 0
Cold Pain Threshold as measured by a Peltier Thermode (Medoc, Israel), using a 3x5cm thermode strapped to the forearm. Temperature drops at a rate of 1 degree/sec. Subject presses switch when perceives painful cold - temperature recorded.
Timepoint [1] 244594 0
Primary Timepoint: 2 weeks post start of intervention (15th day)
Secondary Timepoint (analysed if Primary Timepoint significant): 2 days post start of intervention
Secondary outcome [2] 244595 0
Heat Pain Threshold, as measured by a Peltier Thermode (Medoc, Israel), using a 3x5cm thermode strapped to the forearm. Temperature rises at a rate of 1 degree/sec. Subject presses switch when perceives painful heat - temperature recorded.
Timepoint [2] 244595 0
Primary Timepoint: 2 weeks post start of intervention (15th day)
Secondary Timepoint (analysed if Primary Timepoint significant): 2 days post start of intervention
Secondary outcome [3] 244596 0
Aggregated Locomotor Score: calculated by summing the mean times scores in secs of 3 functional activities: 8m walk time, short stair ascent/descent, time taken to walk 2m, sit in a chair, stand, walk back 2m.
Timepoint [3] 244596 0
Primary Timepoint: 2 weeks post start of intervention (15th day)
Secondary Timepoint (analysed if Primary Timepoint significant): 2 days post start of intervention
Secondary outcome [4] 244597 0
SF36v2 Health Survey measures patient's self assessed overall health status
Timepoint [4] 244597 0
Primary Timepoint: 2 weeks post start of intervention (15th day)
Secondary Timepoint (analysed if Primary Timepoint significant): 2 days post start of intervention
Secondary outcome [5] 244598 0
Pain Quality Assessment Scale
Timepoint [5] 244598 0
Primary Timepoint: 2 weeks post start of intervention (15th day)
Secondary Timepoint (analysed if Primary Timepoint significant): 2 days post start of intervention
Secondary outcome [6] 244599 0
Pain DETECT Neuropathic Pain Diagnostic Questionnaire measures patient's self-assessed pain intensity and quality.
Timepoint [6] 244599 0
Primary Timepoint: 2 weeks post start of intervention (15th day)
Secondary Timepoint (analysed if Primary Timepoint significant): 2 days post start of intervention

Eligibility
Key inclusion criteria
i) unilateral diagnosis of Knee Osteoarthritis (OA) >6 months
ii) knee pain >4/10 on WOMAC pain subscale
iii) if pain in contralateral knee, no greater than "mild"
iv) no other significant joint involvement
v) American Rheumatology Association (ARA) functional Class I, II or III
vi) no athroscopy or injections into index knee in last 6 months.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i) history of systemic inflammatory or chronic pain disorders (especially fibromyalgia)
ii) neurological deficit
iii) recent (<6 months) lower limb surgery
iv) allergic reaction to Non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin
v) skin allergies, dermatitis
vi) contraindications to Cox-2 inhibitors: congestive heart failure (New York Heart Association Classifications II-IV); unstable hypertension; ischaemic heart disease, peripheral artery disease, cerebrovascular disease including coronary artery bypass graft or angioplasty within 1 year; severe hepatic dysfunction; active gastro-intestinal tract bleeding or peptic ulceration; reduced creatinine clearance <30mL/min
vii) current use of high dose (>325mg daily) aspirin

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be voluntarily recruited for the study via General Practitioner, Rheumatology and other health care professional surgeries (physiotherapists, chiropracters, masseurs etc). They will then be medically assessed by the study Rheumatologist for inclusion / exclusion criteria. Once enrolled, participants will be randomly allocated to placebo or active intervention groups by allocation of coded clinical supplies (supplied by Merck). The allocation code will be kept in sealed envelope by the study Pharmacist, meaning that all investigators will be blinded to group allocation until after data analysis. The only exception would be in case of serous adverse even, in which case only the study Pharmacist will access the decoded data for that subject alone.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/08/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237191 0
Commercial sector/Industry
Name [1] 237191 0
Merck & Co. Inc (Investigator InitiatedStudy Programme)
Country [1] 237191 0
United States of America
Primary sponsor type
University
Name
Curtin University of technology
Address
GPO Box U1987
Perth
WA 6845
Country
Australia
Secondary sponsor category [1] 4684 0
Individual
Name [1] 4684 0
Professor Tony Wright
Address [1] 4684 0
School of Physiotherapy,
Curtin University of Technology
GPO Box U1987
Perth
WA 6845
Country [1] 4684 0
Australia
Secondary sponsor category [2] 4685 0
Individual
Name [2] 4685 0
Penny Moss
Address [2] 4685 0
School of Physiotherapy,
Curtin University of Technology
GPO Box U1987
Perth
WA 6845
Country [2] 4685 0
Australia
Secondary sponsor category [3] 4686 0
Individual
Name [3] 4686 0
Dr. Heather Benson
Address [3] 4686 0
School of Physiotherapy,
Curtin University of Technology
GPO Box U1987
Perth
WA 6845
Country [3] 4686 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 239285 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 239285 0
Ethics committee country [1] 239285 0
Australia
Date submitted for ethics approval [1] 239285 0
24/04/2009
Approval date [1] 239285 0
Ethics approval number [1] 239285 0
HR47-2009
Ethics committee name [2] 239336 0
Royal Perth Hospital Human Research Ethics Committee
Ethics committee address [2] 239336 0
Ethics committee country [2] 239336 0
Australia
Date submitted for ethics approval [2] 239336 0
10/07/2009
Approval date [2] 239336 0
Ethics approval number [2] 239336 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29783 0
Address 29783 0
Country 29783 0
Phone 29783 0
Fax 29783 0
Email 29783 0
Contact person for public queries
Name 13030 0
Penny Moss
Address 13030 0
School of Physiotherapy
Curtin University of Technology
GPO Box U1987
Perth
WA 6845
Country 13030 0
Australia
Phone 13030 0
+61 8 9266 3668
Fax 13030 0
+61 8 9266 4644
Email 13030 0
[email protected]
Contact person for scientific queries
Name 3958 0
Professor Tony Wright
Address 3958 0
School of Physiotherapy
Curtin University of Technology
GPO Box U1987
Perth
WA 6845
Country 3958 0
Australia
Phone 3958 0
+61 8 9266 3618
Fax 3958 0
+61 8 9266 4644
Email 3958 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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