Clinical trial • Phase IV • Other
FLUCONAZOLE for Laryngeal leukoplakia
Phase IV trial of FLUCONAZOLE for Laryngeal leukoplakia. None/Not specified-controlled. 90 participants.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Laryngeal leukoplakia
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 16-10-2024
- First CTIS Authorization Date
- 30-10-2024
Trial design
None/Not specified-controlled Phase IV trial across 1 site in Finland.
- Comparator
- None/Not specified
- Target Sample Size
- 90
Eligibility
Recruits 90 No vulnerable populations selected; isVulnerablePopulationSelected=false. No special vulnerable population consent or assent handling described in the record..
- Pregnancy Exclusion
- pregnancy
- Vulnerable Population
- No vulnerable populations selected; isVulnerablePopulationSelected=false. No special vulnerable population consent or assent handling described in the record.
Inclusion criteria
- {"criterion_text":"- laryngeal leukoplakia"}
Exclusion criteria
- {"criterion_text":"- a known allergy to the investigational medicinal product, pregnancy, hepatic insufficiency, drug interaction, warfarin"}
Endpoints
Primary endpoints
- {"endpoint_text":"- disappearance of leukoplakia","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 90
- Recruitment Window Months
- 95
- Consent Approach
- Informed consent is obtained using subject information and informed consent form documents (documents listed: 'LARLEUKO potilastiedote', 'Suostumuslomake _2020-006011-23'). No details on assent, age-specific consent documents, or languages available are provided in the record.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 90
Finland
- Earliest CTIS Part Ii Submission Date
- 15-10-2024
- Latest Decision Or Authorization Date
- 30-10-2024
- Processing Time Days
- 15
- Number Of Sites
- 1
- Number Of Participants
- 90
Sites
- Site Name
- HUS-Yhtymae
- Department Name
- Korvaklinikka
- Contact Person Name
- Petra Pietarinen
- Contact Person Email
- petra.pietarinen@hus.fi
Sponsor
Primary sponsor
- Full Name
- HUS-Yhtymae
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Finland
Investigational products
- Investigational Product Name
- Diflucan 100 mg kovat kapselit
- Active Substance
- FLUCONAZOLE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Marketing authorisation present (product record includes marketing authorisation and MA numbers)
- Maximum Dose
- 4200 mg
- Investigational Product Name
- Kefexin 500 mg tabletti, kalvopäällysteinen
- Active Substance
- CEFALEXIN MONOHYDRATE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Marketing authorisation present (product record includes marketing authorisation and MA numbers)
- Maximum Dose
- 63000 mg
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