Condition category
Musculoskeletal Diseases
Date applied
28/07/2008
Date assigned
30/09/2008
Last edited
26/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ernest Choy

ORCID ID

Contact details

Weston Education Centre
10 Cutcombe Road
London
SE5 9RJ
United Kingdom
+44 (0)207 848 5206
kch-tr.kms-ctu@nhs.net

Additional identifiers

EudraCT number

2006-000395-32

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Protocol to investigate the effect of cyclo-oxygenase (COX)-2 inhibition on reducing central sensitisation of pain in osteoarthritis

Acronym

Study hypothesis

This study aims to assess whether cyclo-oxygenase (COX)-2 selective inhibition by etoricoxib reduces central sensitisation of pain in patients with chronic osteoarthritis (OA) using functional magnetic resonance imaging (fMRI) scan.

Ethics approval

St Thomas' Hospital Research Ethics Committee. Date of approval: 23/03/2006

Study design

Non-randomised controlled trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Osteoarthritis

Intervention

16 patients will be recruited from the Rheumatology Outpatient Clinic of King's College Hospital. 16 healthy controls will be recruited from the staff and student population at King's College London (32 participants in total).

Interventions: Etoricoxib (oral) 60 mg daily for 2 weeks vs no treatment

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Pressure pain thresholds (PPTs) will be determined using a pressure algometer. Patients will be asked to indicate the site of ongoing pain on a mannequin. This site and the homologous contralateral site will be marked with a pen and noted in the patient record. The pressure pain level will be assessed twice at each site (rate of stimulus increase 50 kPa; probe area 1 cm2) and the average of two perception levels will be calculated as the individual PPT for that site.
2. Functional MRI (fMRI) will be used to assess brain responses to a standardised pain provocation produced by pressure delivered to a non fibromyalgia syndrome (FMS) pressure point of the knee. The fMRI evaluation will involve multiple 8 min scans using an event-related design. Pressure stimuli of 2.5 seconds duration will be delivered to the right knee at random intervals varying between 10 and 20 seconds. This will then be repeated for the left knee. The control group will have only one scan.

Assessments will be carried out at baseline and after 2 weeks of treatment with etoricoxib for OA patients. Healthy controls will only complete baseline assessments.

Secondary outcome measures

1. Mechanoreceptive function
2. Sensitivity to stimulus invoked pain

Assessments will be carried out at baseline and after 2 weeks of treatment with etoricoxib for OA patients. Healthy controls will only complete baseline assessments.

Overall trial start date

01/09/2008

Overall trial end date

01/03/2009

Reason abandoned

Eligibility

Participant inclusion criteria

For all participants:
1. Both males and females, age >18 years old
2. Those who are right handed
3. Signed informed consent

For participants with OA:
1. Patients with ACR criteria defined OA of the knee
2. Radiological OA
3. Patients who have been suffering from pain for more than 1 year

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

32

Participant exclusion criteria

1. History of hypersensitivity to the active substance or to any of the excipients
2. Active peptic ulceration or active gastro-intestinal (GI) bleeding
3. Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions after taking acetylsalicylic acid or non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2 inhibitors
4. Pregnancy and lactation
5. Severe hepatic dysfunction (serum albumin <25 g/l or Child-Pugh score >=10)
6. Estimated renal creatinine clearance <30 ml/min
7. Inflammatory bowel disease
8. Congestive heart failure (New York Heart Association [NYHA] II-IV)
9. Patients with hypertension whose blood pressure has not been adequately controlled

Recruitment start date

01/09/2008

Recruitment end date

01/03/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Weston Education Centre
London
SE5 9RJ
United Kingdom

Sponsor information

Organisation

Kings College London (UK)

Sponsor details

Strand
London
WC2R 2LS
United Kingdom
+44 (0)20 7836 5454
kch-tr.kms-ctu@nhs.net

Sponsor type

University/education

Website

http://www.kcl.ac.uk

Funders

Funder type

Industry

Funder name

Merck Sharp & Dohme Ltd (MSD) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

26/08/2016: No publications found, verifying study status with principal investigator