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Clinical Trials/EUCTR2008-007309-35-GB
EUCTR2008-007309-35-GB
Active, not recruiting
Phase 1

The Cerebrospinal Fluid (CSF) pharmacokinetics of a single pre-operative intravenous bolus dose of diclofenac (Dyloject) in comparison of diclofenac infusion (Voltarol) - Dyloject CSF Pharmacokinetics

Barts and The London NHS Trust0 sites0 target enrollmentJanuary 20, 2009
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ConditionsIn healthy volunteers, the aim is to characterise the CSF diclofenac pharmacokinetics following administration of a single bouls of intravenous Dyloject.MedDRA version: 9.1 Level: LLT Classification code 10066714 Term: Acute painMedDRA version: 9.1 Level: LLT Classification code 10036236 Term: Postoperative pain reliefMedDRA version: 9.1 Level: LLT Classification code 10054711 Term: Postoperative pain
DrugsDylojectVoltarol Ampoules

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
In healthy volunteers, the aim is to characterise the CSF diclofenac pharmacokinetics following administration of a single bouls of intravenous Dyloject.
Sponsor
Barts and The London NHS Trust
Status
Active, not recruiting
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 20, 2009
End Date
May 21, 2010
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
Barts and The London NHS Trust

Eligibility Criteria

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
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •1\.History of bleeding diathesis or use of anticoagulant or antiplatelet agent.
  • •2\.History of spinal or neurological disease (incl. raised intracranial pressure), or surgery contraindicating spinal anaesthesia.
  • •3\.Use of aspirin within 72 hours prior to surgery.
  • •4\.Use of other NSAID’s, paracetamol or steroids within 12 hours before surgery.
  • •5\.Hypersensitivity to diclofenac or local anaesthetics.
  • •6\.AST, ALT or BUN \>1\.5x 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

Outcomes

Primary Outcomes

Not specified

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