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

May 1, 2012 updated by: Penny Moss, Curtin University

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Royal Perth Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Sugar pill
Drug: Sugar pill
Daily dose (1 pill), oral delivery, 14 days
Experimental: Etoricoxib 60 mg
Drug: Etoricoxib (Arcoxia)
60 mg, daily dose, oral delivery, 14 days duration
Other Names:
  • Arcoxia

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Curtin University

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Tony Wright, PhD, Curtin University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

June 23, 2009

First Submitted That Met QC Criteria

June 23, 2009

First Posted (Estimate)

June 24, 2009

Study Record Updates

Last Update Posted (Estimate)

May 3, 2012

Last Update Submitted That Met QC Criteria

May 1, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Moss IISP#36409
  • 3144 Wright-Merck
  • HR47-2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on Etoricoxib (Arcoxia)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe