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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00927004




Registration number
NCT00927004
Ethics application status
Date submitted
23/06/2009
Date registered
23/06/2009
Date last updated
1/05/2012

Titles & IDs
Public title
Efficacy of Etoricoxib 60 mg in Modifying Pain Hypersensitivity in People With Knee Osteoarthritis
Scientific 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.
Secondary ID [1] 0 0
3144 Wright-Merck
Secondary ID [2] 0 0
Moss IISP#36409
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 0 0
Pain 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Etoricoxib (Arcoxia)
Treatment: Drugs - Sugar pill

Experimental: Etoricoxib 60 mg -

Placebo Comparator: Sugar pill -


Treatment: Drugs: Etoricoxib (Arcoxia)
60 mg, daily dose, oral delivery, 14 days duration

Treatment: Drugs: Sugar pill
Daily dose (1 pill), oral delivery, 14 days

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pressure Pain Threshold
Timepoint [1] 0 0
15 days, 3 days
Primary outcome [2] 0 0
Western Ontario and McMaster University Osteoarthritis Index (knee) - pain subscale
Timepoint [2] 0 0
15 days, 3 days
Secondary outcome [1] 0 0
Cold Pain Threshold
Timepoint [1] 0 0
15 days, 3 days
Secondary outcome [2] 0 0
Topical Cold Response
Timepoint [2] 0 0
15 days, 3 days
Secondary outcome [3] 0 0
Functional Measure (aggregated locomotor score, sit-to-stand time)
Timepoint [3] 0 0
15 days, 3 days
Secondary outcome [4] 0 0
WOMAC (knee) total
Timepoint [4] 0 0
15 days, 3 days
Secondary outcome [5] 0 0
SF-36v2
Timepoint [5] 0 0
15 days, 3 days
Secondary outcome [6] 0 0
Pain Quality Assessment Scale
Timepoint [6] 0 0
15 days, 3 days
Secondary outcome [7] 0 0
PainDETECT questionnaire
Timepoint [7] 0 0
15 days, 3 days

Eligibility
Key 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
Minimum age
50 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
6000 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
Curtin University
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Merck Sharp & Dohme Corp.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT00927004
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Tony Wright, PhD
Address 0 0
Curtin University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications