Efficacy of Etoricoxib 60 mg in Modifying Pain Hypersensitivity in People With Knee Osteoarthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteoarthritis Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Etoricoxib 60 mg

Group Type EXPERIMENTAL

Etoricoxib (Arcoxia)

Intervention Type DRUG

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

Sugar pill

Group Type PLACEBO_COMPARATOR

Sugar pill

Intervention Type DRUG

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

Interventions

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Etoricoxib (Arcoxia)

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

Intervention Type DRUG

Sugar pill

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

Intervention Type DRUG

Other Intervention Names

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Arcoxia

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes