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

This study has been completed.
Sponsor:
Collaborator:
Merck
Information provided by (Responsible Party):
Penny Moss, Curtin University of Technology
ClinicalTrials.gov Identifier:
NCT00927004
First received: June 23, 2009
Last updated: May 1, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
Pain
 Drug: Etoricoxib (Arcoxia)
Drug: Sugar pill
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Curtin University of Technology:

Primary Outcome Measures:
  • Pressure Pain Threshold [ Time Frame: 15 days, 3 days ] [ Designated as safety issue: No ]
  • Western Ontario and McMaster University Osteoarthritis Index (knee) - pain subscale [ Time Frame: 15 days, 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cold Pain Threshold [ Time Frame: 15 days, 3 days ] [ Designated as safety issue: No ]
  • Topical Cold Response [ Time Frame: 15 days, 3 days ] [ Designated as safety issue: No ]
  • Functional Measure (aggregated locomotor score, sit-to-stand time) [ Time Frame: 15 days, 3 days ] [ Designated as safety issue: No ]
  • WOMAC (knee) total [ Time Frame: 15 days, 3 days ] [ Designated as safety issue: No ]
  • SF-36v2 [ Time Frame: 15 days, 3 days ] [ Designated as safety issue: No ]
  • Pain Quality Assessment Scale [ Time Frame: 15 days, 3 days ] [ Designated as safety issue: No ]
  • PainDETECT questionnaire [ Time Frame: 15 days, 3 days ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: August 2010
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Etoricoxib 60 mg Drug: Etoricoxib (Arcoxia)
60 mg, daily dose, oral delivery, 14 days duration
Other Name: Arcoxia
Placebo Comparator: Sugar pill Drug: Sugar pill
Daily dose (1 pill), oral delivery, 14 days

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00927004

Locations
Australia, Western Australia
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
Sponsors and Collaborators
Curtin University of Technology
Merck
Investigators
Principal Investigator: Tony Wright, PhD Curtin University of Technology
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Penny Moss, Lecturer, Curtin University of Technology
ClinicalTrials.gov Identifier: NCT00927004     History of Changes
Other Study ID Numbers: Moss IISP#36409, 3144 Wright-Merck, HR47-2009
Study First Received: June 23, 2009
Last Updated: May 1, 2012
Health Authority: Australia: National Health and Medical Research Council
Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee

Keywords provided by Curtin University of Technology:
mechanical hyperalgesia
cold hyperalgesia
chronic pain

Additional relevant MeSH terms:
Hyperalgesia
Hypersensitivity
Osteoarthritis
Osteoarthritis, Knee
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Immune System Diseases
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Etoricoxib
 Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 16, 2013