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

Primary Purpose

Osteoarthritis, Pain

Status

Completed

Phase

Phase 4

Locations

Australia

Study Type

Interventional

Intervention

Etoricoxib (Arcoxia)

Sugar pill

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring mechanical hyperalgesia, cold hyperalgesia, chronic pain

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Royal Perth Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Etoricoxib 60 mg

Sugar pill

Arm Description

Outcomes

Primary Outcome Measures

Pressure Pain Threshold

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

Secondary Outcome Measures

Cold Pain Threshold

Topical Cold Response

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

WOMAC (knee) total

SF-36v2

Pain Quality Assessment Scale

PainDETECT questionnaire

Full Information

NCT ID

NCT00927004

First Posted

June 23, 2009

Last Updated

May 1, 2012

Sponsor

Curtin University

Collaborators

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00927004

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Completed

Study Start Date

August 2010 (undefined)

Primary Completion Date

November 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Curtin University

Collaborators

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Pain

Keywords

mechanical hyperalgesia, cold hyperalgesia, chronic pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Etoricoxib 60 mg

Arm Type

Experimental

Arm Title

Sugar pill

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Etoricoxib (Arcoxia)

Other Intervention Name(s)

Arcoxia

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Sugar pill

Intervention Description

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

Primary Outcome Measure Information:

Title

Pressure Pain Threshold

Time Frame

15 days, 3 days

Title

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

Time Frame

15 days, 3 days

Secondary Outcome Measure Information:

Title

Cold Pain Threshold

Time Frame

15 days, 3 days

Title

Topical Cold Response

Time Frame

15 days, 3 days

Title

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

Time Frame

15 days, 3 days

Title

WOMAC (knee) total

Time Frame

15 days, 3 days

Title

SF-36v2

Time Frame

15 days, 3 days

Title

Pain Quality Assessment Scale

Time Frame

15 days, 3 days

Title

PainDETECT questionnaire

Time Frame

15 days, 3 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tony Wright, PhD

Organizational Affiliation

Curtin University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Royal Perth Hospital

City

Perth

State/Province

Western Australia

ZIP/Postal Code

6000

Country

Australia

12. IPD Sharing Statement

Citations:

PubMed Identifier

28778815

Citation

Moss P, Benson HAE, Will R, Wright A. Fourteen days of etoricoxib 60 mg improves pain, hyperalgesia and physical function in individuals with knee osteoarthritis: a randomized controlled trial. Osteoarthritis Cartilage. 2017 Nov;25(11):1781-1791. doi: 10.1016/j.joca.2017.07.009. Epub 2017 Aug 2.

Results Reference

derived

Links:

URL

http://physiotherapy.curtin.edu.au

Description

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

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