Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00927004




Registration number
NCT00927004
Ethics application status
Date submitted
23/06/2009
Date registered
24/06/2009
Date last updated
3/05/2012

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
Sex
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
1/08/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2011
Sample size
Target
Accrual to date
Final
80
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 LLC
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/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00927004