Condition category
Surgery
Date applied
23/12/2008
Date assigned
12/02/2009
Last edited
09/06/2016
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 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

http://www.bartsandthelondon.org.uk/

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

Publication citations

Additional files

Editorial Notes

09/06/2016: No publications found, verifying study status with principal investigator.