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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00927004

Enrollment

Registered

2009-06-24

Start date

2010-08-31

Completion date

2011-12-31

Last updated

2012-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Pain

Keywords

mechanical hyperalgesia, cold hyperalgesia, chronic pain

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.

Interventions

DRUGEtoricoxib (Arcoxia)

60 mg, daily dose, oral delivery, 14 days duration

DRUGSugar pill

Daily dose (1 pill), oral delivery, 14 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Pressure Pain Threshold	15 days, 3 days
Western Ontario and McMaster University Osteoarthritis Index (knee) - pain subscale	15 days, 3 days

Secondary

Measure	Time frame
Functional Measure (aggregated locomotor score, sit-to-stand time)	15 days, 3 days
WOMAC (knee) total	15 days, 3 days
Cold Pain Threshold	15 days, 3 days
Pain Quality Assessment Scale	15 days, 3 days
PainDETECT questionnaire	15 days, 3 days
SF-36v2	15 days, 3 days
Topical Cold Response	15 days, 3 days

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026