Contact information
Type
Scientific
Primary contact
Dr Nilesh Randive
ORCID ID
Contact details
PARC
Unit 11
First Floor Dominion House
59 Bartholomew Close
West Smithfield
London
EC1A 7BE
United Kingdom
-
drnilran@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
BLT-Dylo-07/01
Study information
Scientific title
The cerebrospinal fluid (CSF) pharmacokinetics of a single pre-operative intravenous bolus dose of diclofenac (Dyloject®) in comparison to diclofenac infusion (Voltarol®): a prospective open-label randomised single-centre phase IV study
Acronym
Study hypothesis
Dyloject®, a novel injectable diclofenac bolus is ideally suited for peri-operative anti-inflammatory analgesic use, and in view of the high peak plasma concentration following rapid intravenous administration may facilitate greater penetration of the central nervous system (CNS) and hence exert additional beneficial central actions.
Ethics approval
South East Regional Ethics Committee approval decision awaiting as of 14th January 2009
Study design
Prospective open-label randomised single-centre phase IV study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Peri-operative anti-inflammatory analgesia
Intervention
Dyloject® (75 mg) single intravenous bolus or Voltarol® ampoules (75 mg) single intravenous infusion will be given pre-operatively prior to spinal anaesthesia for surgery and cerebrospinal fluid sampling.
Intervention type
Drug
Phase
Phase IV
Drug names
Diclofenac (Dyloject®, Voltarol®)
Primary outcome measures
Characterisation of the CSF diclofenac kinetics following administration of intravenous Dyloject®. The patients will receive the drug at 65, 35 and 5 minutes prior to CSF sampling.
Secondary outcome measures
1. Characterise CSF PGE2 levels in the normal uninjured human with or without diclofenac
2. Establish baseline CSF and plasma prostaglandins and cytokine levels
3. Examine the relationship between CNS and plasma PGE2 levels
4. Establish proof of concept for further analyses: an optional continuation of this pilot study is proposed dependant on interim analysis of the first phase. This would entail a further 18 patients entering the study.
Overall trial start date
05/02/2009
Overall trial end date
05/08/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Male or female patients aged at least 18 years
2. Scheduled to undergo surgery performed under spinal anaesthesia
3. Patients must be inpatients
4. Patient has given written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20
Participant exclusion criteria
1. History of bleeding diathesis or use of anticoagulant or antiplatelet agent
2. History of spinal or neurological disease (including raised intracranial pressure), or surgery contraindicating spinal anaesthesia
3. Use of aspirin within 72 hours prior to surgery
4. Use of other non-steroidal anti-inflammatory drugs (NSAIDs), paracetamol or steroids within 12 hours before surgery
5. Hypersensitivity to diclofenac or local anaesthetics
6. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) or blood urea nitrogen (BUN) greater than 1.5 x the upper limit of the reference range, or creatinine greater than the upper limit of the reference range
7. Any other abnormal laboratory results considered clinically significant in relation to this study by the investigator
8. Presence of oliguria, anaemia, hypotension or hypovolaemia
9. Contraindications to NSAID/diclofenac
10. Patients who are unwilling or unable to conform to the protocol
11. Patients who have received an unlicensed drug less than 30 days prior to the study
12. Patients who have been previously admitted to the study
13. Pregnant or lactating females or females of child-bearing potential who are unwilling to undertake a pregnancy test (urinary beta-human chorionic gonadotropin [B-HCG])
14. A bloody tap (visible blood in CSF)
15. Patients with a hypersensitivity to the excipients hydroxypropylbetadex (HPßCD) or monothioglycerol
16. Operations with high risk of haemorrhage
17. Patients who are considered unsuitable by the responsible anaesthetist - for whom spinal anaesthesia is deemed to constitute an unacceptable, increased risk
18. Patients who are involved in existing research
Recruitment start date
05/02/2009
Recruitment end date
05/08/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
PARC
London
EC1A 7BE
United Kingdom
Sponsor information
Organisation
Barts and The London NHS Trust (UK)
Sponsor details
24 - 26 Walden Street
Whitechapel
London
E1 2AB
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Javelin Pharmaceuticals UK Limited (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