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
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