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
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