OsteoarthritisPhase 4NCT00927004
Efficacy of Etoricoxib 60 mg in Modifying Pain Hypersensitivity in People With Knee Osteoarthritis
A Phase 4 study testing Etoricoxib (Arcoxia) and Sugar pill in people with Osteoarthritis and Pain, run by Curtin University at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Pain
- What is being tested?
- Etoricoxib (Arcoxia) and Sugar pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteAustralia
- Study dates
- Aug 2010to Dec 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Osteoarthritis, Pain
- Being tested
- Etoricoxib (Arcoxia), Sugar pill
- Keywords
- mechanical hyperalgesia, cold hyperalgesia, chronic pain
- Medical subject headings
- Osteoarthritis, Pain, Hyperalgesia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Etoricoxib (Arcoxia)Drug
Also called Arcoxia
60 mg, daily dose, oral delivery, 14 days duration
Sugar pillDrug
Daily dose (1 pill), oral delivery, 14 days
| Study group | Role | What they receive |
|---|---|---|
| Etoricoxib 60 mg | Experimental | Not described Receives: Drug: Etoricoxib (Arcoxia) |
| Sugar pill | Placebo comparator | Not described Receives: Drug: Sugar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure Pain Threshold
Measured: 15 days, 3 days
Western Ontario and McMaster University Osteoarthritis Index (knee) - pain subscale
Measured: 15 days, 3 days
Secondary outcomes (7)
Cold Pain Threshold
Measured: 15 days, 3 days
Topical Cold Response
Measured: 15 days, 3 days
Functional Measure (aggregated locomotor score, sit-to-stand time)
Measured: 15 days, 3 days
WOMAC (knee) total
Measured: 15 days, 3 days
SF-36v2
Measured: 15 days, 3 days
Pain Quality Assessment Scale
Measured: 15 days, 3 days
PainDETECT questionnaire
Measured: 15 days, 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2009 (estimated)
- Study startAug 2010
- Primary completionNov 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Curtin University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Penny Moss, Curtin University
- Investigators
- Tony Wright, PhD, Principal investigator, Curtin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00927004
- Sponsor's protocol ID
- Moss IISP#36409
- Other IDs
- 3144 Wright-Merck, HR47-2009
- Status last verified
- May 2012
- First submitted
- 23 Jun 2009
- Last updated
- 3 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28778815
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00927004
- Acronym / sponsor ID
- Moss IISP#36409
- Conditions
- Osteoarthritis, Pain
- Keywords
- mechanical hyperalgesia, cold hyperalgesia, chronic pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Curtin UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Aug 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 24 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Etoricoxib 60 mg | Experimental | Drug: Etoricoxib (Arcoxia) |
| Sugar pill | Placebo comparator | Drug: Sugar pill |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Etoricoxib (Arcoxia)Also: Arcoxia60 mg, daily dose, oral delivery, 14 days duration | Drug | Etoricoxib 60 mg |
| Sugar pillDaily dose (1 pill), oral delivery, 14 days | Drug | Sugar pill |
Primary outcome
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
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2012.
- Derived from this study: PubMed 28778815Moss 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tony Wright, PhD principal investigator
Curtin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Etoricoxib (Arcoxia) and Sugar pill in people with Osteoarthritis and Pain, run by Curtin University at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure Pain Threshold (time frame: 15 days, 3 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00927004, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2012.