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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 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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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 Penny Moss, Curtin University of Technology:

Primary Outcome Measures:
  • Pressure Pain Threshold [ Time Frame: 15 days, 3 days ]
  • Western Ontario and McMaster University Osteoarthritis Index (knee) - pain subscale [ Time Frame: 15 days, 3 days ]

Secondary Outcome Measures:
  • Cold Pain Threshold [ Time Frame: 15 days, 3 days ]
  • Topical Cold Response [ Time Frame: 15 days, 3 days ]
  • Functional Measure (aggregated locomotor score, sit-to-stand time) [ Time Frame: 15 days, 3 days ]
  • WOMAC (knee) total [ Time Frame: 15 days, 3 days ]
  • SF-36v2 [ Time Frame: 15 days, 3 days ]
  • Pain Quality Assessment Scale [ Time Frame: 15 days, 3 days ]
  • PainDETECT questionnaire [ Time Frame: 15 days, 3 days ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Tony Wright, PhD Curtin University
  More Information

Additional Information:
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

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

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

ClinicalTrials.gov processed this record on August 21, 2017