Condition category
Infections and Infestations
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
30/11/2015
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 Michael Potter

ORCID ID

Contact details

Department of Haematology
The Royal Free & University College Medical School
Pond Street
Hampstead
London
NW3 2QG
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0256124185

Study information

Scientific title

Randomised open-label cross over study to investigate patient tolerance of itraconazole liquid when administered either at room temperature or chilled: ambient vs chilled itraconazole study

Acronym

Study hypothesis

Will altering the temperature of prophylactic itraconazole suspension make it more palatable to patients and encourage compliance?

Ethics approval

Not provided at time of registration

Study design

Randomised open controlled crossover group trial

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Fungal infections in immunocompromised patients

Intervention

Clinical trial of ambient versus chilled itraconazole liquid

Intervention type

Drug

Phase

Not Applicable

Drug names

Itraconazole

Primary outcome measures

Service outcome development

Secondary outcome measures

Not provided at time of registration

Overall trial start date

20/05/2003

Overall trial end date

30/08/2003

Reason abandoned

Eligibility

Participant inclusion criteria

20 patients

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

20

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

20/05/2003

Recruitment end date

30/08/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Royal Free & University College Medical School
London
NW3 2QG
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

The Royal Free Hampstead NHS Trust (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