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 |
| Protocol serial number | N0256124185 |
| Sponsor | Department of Health |
| Funder | The Royal Free Hampstead NHS Trust (UK) |
- 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
Scientific
Department of Haematology
The Royal Free & University College Medical School
Pond Street
Hampstead
London
NW3 2QG
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised open controlled crossover group trial |
| Secondary study design | Randomised cross over trial |
| Study type | Participant information sheet |
| 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 |
| Study objectives | Will 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) studied | Fungal infections in immunocompromised patients |
| Intervention | Clinical trial of ambient versus chilled itraconazole liquid |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Itraconazole |
| Primary outcome measure(s) |
Service outcome development |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/08/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 20 |
| Key inclusion criteria | 20 patients |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 20/05/2003 |
| Date of final enrolment | 30/08/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
The Royal Free & University College Medical School
London
NW3 2QG
United Kingdom
NW3 2QG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
13/02/2018: No publications found, study status unverified
