Overview
Sponsor-declared trial summary
laryngeal leukoplakia
Antimicrobial treatment of laryngeal leukoplakia
Key facts
- Sponsor
- HUS-Yhtymae
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Otorhinolaryngologic Diseases [C09]
- Decision date (initial)
- 2024-10-30
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-518793-14-00
- EudraCT number
- 2020-006011-23
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
Antimicrobial treatment of laryngeal leukoplakia
Conditions and MedDRA coding
laryngeal leukoplakia
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- laryngeal leukoplakia
Exclusion criteria 1
- a known allergy to the investigational medicinal product, pregnancy, hepatic insufficiency, drug interaction, warfarin
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- disappearance of leukoplakia
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Diflucan 100 mg kovat kapselit
PRD497811 · Product
- Active substance
- Fluconazole
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 4200 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- J02AC01 — FLUCONAZOLE
- Marketing authorisation
- 10045
- MA holder
- PFIZER OY
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Kefexin 500 mg tabletti, kalvopäällysteinen
PRD545789 · Product
- Active substance
- Cefalexin Monohydrate
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1500 mg milligram(s)
- Max total dose
- 63000 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01DB01 — -
- Marketing authorisation
- 7281
- MA holder
- ORION CORPORATION
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
HUS-Yhtymae
- Sponsor organisation
- HUS-Yhtymae
- Address
- Stenbackinkatu 9
- City
- Helsinki
- Postcode
- 00290
- Country
- Finland
Scientific contact point
- Organisation
- HUS-Yhtymae
- Contact name
- HUS Korvaklinikka
Public contact point
- Organisation
- HUS-Yhtymae
- Contact name
- HUS Korvaklinikka
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Authorised, recruitment pending | 90 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Tutkimussuunnitelma _2020-006011-23 | 1 |
| Recruitment arrangements (for publication) | Transitiohakemus | 1 |
| Subject information and informed consent form (for publication) | LARLEUKO potilastiedote | 3 |
| Subject information and informed consent form (for publication) | Suostumuslomake _2020-006011-23 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Diflucan | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-16 | Finland | Acceptable 2024-10-29
|
2024-10-30 |