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

ISRCTN ISRCTN17347739
DOI https://doi.org/10.1186/ISRCTN17347739
Secondary identifying numbers N0256124185
Submission date
30/09/2004
Registration date
30/09/2004
Last edited
13/02/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
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 Michael Potter
Scientific

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

Study information

Study designRandomised open controlled crossover group trial
Primary study designInterventional
Secondary study designRandomised cross over trial
Study setting(s)Not specified
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleRandomised 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
Study objectivesWill altering the temperature of prophylactic itraconazole suspension make it more palatable to patients and encourage compliance?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedFungal infections in immunocompromised patients
InterventionClinical trial of ambient versus chilled itraconazole liquid
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Itraconazole
Primary outcome measureService outcome development
Secondary outcome measuresNot provided at time of registration
Overall study start date20/05/2003
Completion date30/08/2003

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants20
Key inclusion criteria20 patients
Key exclusion criteriaDoes not match inclusion criteria
Date of first enrolment20/05/2003
Date of final enrolment30/08/2003

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

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

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

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

Funders

Funder type

Hospital/treatment centre

The Royal Free Hampstead NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

13/02/2018: No publications found, study status unverified