Home » Trials » SLCTR/2007/003


Screening brain targeted novel transcranial drug delivery in human volunteers

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SLCTR Registration Number

SLCTR/2007/003


Date of Registration

18 May 2007

The date of last modification

Jan 30, 2019


View original TRDS


Trial Status



Application Summary


Scientific Title of Trial

Screening brain targeted novel transcranial drug delivery in human volunteers


Public Title of Trial

Study of a novel route of brain targeted drug delivery in human volunteers


Disease or Health Condition(s) Studied

New route of brain targeted drug delivery using diazepam


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trial Number

None


Any other number(s) assigned to the trial and issuing authority

EC/07/001 (Ethical Review Committee, Faculty of Medicine, University of Colombo)


Trial Details


What is the research question being addressed?

Brain targeted drug delivery to avoid systemic side effects ?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Double blinded


Control

Standard therapy/practice


Assignment

Crossover


Purpose

Other


Study Phase

Not Available


Intervention(s) planned

Assessment of sedative effect of diazepam using clinical criteria and EEG after application of the drug in oil solution


Inclusion criteria

Healthy volunteers below 50 years with normal EEGs and not under any drug therapy which produce sedative effects or EEG changes


Exclusion criteria

Volunteers above 50 years, abnormal EEGs and those under drugs which cause sedation or EEG changes



Primary outcome(s)

    • Sedative effect * Significant excess of beta activity ( 13 Hz) in EEG, Tranquilizing and muscle relaxant effects
    []

Secondary outcome(s)

  1. None

    [

    None

    ]

Target number/sample size

6-7


Countries of recruitment

Sri Lanka


Anticipated start date

2007-03-16


Anticipated end date

2007-05-16


Date of first enrollment


Date of study completion


Recruitment status

Recruiting


Funding source

Improving Relavant and Quality of Undergraduate Education (IRQUE) Project


Regulatory approvals



State of Ethics Review Approval


Status

Approved


Date of Approval


Approval number

EC/07/001


Details of Ethics Review Committee

Name: Ethics Review Committee, Faculty of Medicine, University of Colombo
Institutional Address: No. 25, Kynsey Road, Colombo 00800 Sri Lanka
Telephone: +94-11-2695300 (Extension: 240)
Email: ethicscommitteemfc@gmail.com


Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

W. Pathirana
Senior Lecturer in Pharmacy
Department of Pharmacology, Faculty of Medicine, University of Colombo Kynsey Road, Colombo 08
+94 112691111 Ext. 805

+94 112828314
priyanip@hotmail.com

Contact Person for Public Queries

W. Pathirana
Senior Lecturer in Pharmacy
Department of Pharmacology, Faculty of Medicine, University of Colombo Kynsey Road, Colombo 08
+94 112691111 Ext. 805

+94 112828314
priyanip@hotmail.com


Primary study sponsor/organization

None





Secondary study sponsor (If any)

None





Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?


IPD sharing plan description

Not Available


Study protocol available


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

Yes


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results