The cerebrospinal fluid (CSF) pharmacokinetics of a single pre-operative intravenous bolus dose of diclofenac (Dyloject®) in comparison to diclofenac infusion (Voltarol®)
ISRCTN | ISRCTN37500282 |
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DOI | https://doi.org/10.1186/ISRCTN37500282 |
Secondary identifying numbers | BLT-Dylo-07/01 |
- Submission date
- 23/12/2008
- Registration date
- 12/02/2009
- Last edited
- 09/06/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Nilesh Randive
Scientific
Scientific
PARC
Unit 11, First Floor Dominion House
59 Bartholomew Close
West Smithfield
London
EC1A 7BE
United Kingdom
drnilran@gmail.com |
Study information
Study design | Prospective open-label randomised single-centre phase IV study |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
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 |
Study objectives | 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(s) | South East Regional Ethics Committee approval decision awaiting as of 14th January 2009 |
Health condition(s) or problem(s) studied | 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 |
Pharmaceutical study type(s) | |
Phase | Phase IV |
Drug / device / biological / vaccine name(s) | Diclofenac (Dyloject®, Voltarol®) |
Primary outcome measure | 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 study start date | 05/02/2009 |
Completion date | 05/08/2010 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 20 |
Key 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 |
Key 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 |
Date of first enrolment | 05/02/2009 |
Date of final enrolment | 05/08/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
PARC
London
EC1A 7BE
United Kingdom
EC1A 7BE
United Kingdom
Sponsor information
Barts and The London NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
24 - 26 Walden Street
Whitechapel
London
E1 2AB
England
United Kingdom
Website | http://www.bartsandthelondon.org.uk/ |
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https://ror.org/00b31g692 |
Funders
Funder type
Industry
Javelin Pharmaceuticals UK Limited (UK)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Editorial Notes
09/06/2016: No publications found, verifying study status with principal investigator.