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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Sharp & Dohme Corp.
Investigators
Principal Investigator: Tony Wright, PhD Curtin University of Technology
  More Information

Additional Information:
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
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 01, 2014