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Completed

NCT Number: NCT00927004

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

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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Key information

Conditions

Osteoarthritis Arthritis Chronic Pain Hyperalgesia Joint Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Sensation Disorders Signs and Symptoms Somatosensory Disorders

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Etoricoxib (Arcoxia)

Drug

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

Other names: Arcoxia

Sugar pill

Drug

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

Primary outcomes

  1. Pressure Pain Threshold

    Time frame: 15 days, 3 days

  2. Western Ontario and McMaster University Osteoarthritis Index (knee) - pain subscale

    Time frame: 15 days, 3 days

Secondary outcomes

  1. Cold Pain Threshold

    Time frame: 15 days, 3 days

  2. Topical Cold Response

    Time frame: 15 days, 3 days

  3. Functional Measure (aggregated locomotor score, sit-to-stand time)

    Time frame: 15 days, 3 days

  4. WOMAC (knee) total

    Time frame: 15 days, 3 days

  5. SF-36v2

    Time frame: 15 days, 3 days

  6. Pain Quality Assessment Scale

    Time frame: 15 days, 3 days

  7. PainDETECT questionnaire

    Time frame: 15 days, 3 days

Sponsors and collaborators

Lead sponsor

Curtin University

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study 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.

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 24, 2009
Registry last updated
May 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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