Clinical trial • Phase IV • Other
PREDNISOLONE for Acute laryngitis
Phase IV trial of PREDNISOLONE for Acute laryngitis.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Acute laryngitis
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 17-10-2024
- First CTIS Authorization Date
- 29-10-2024
Trial design
Placebo (White, flat round, uncoated tablet. Diameter 9 mm.) and Prednisolon 20 mg tabletit (active comparator). Dose and schedule not specified in record.-controlled Phase IV trial across 1 site in Finland.
- Comparator
- Placebo (White, flat round, uncoated tablet. Diameter 9 mm.) and Prednisolon 20 mg tabletit (active comparator). Dose and schedule not specified in record.
- Target Sample Size
- 70
- Trial Duration For Participant
- 4
Eligibility
Recruits 70 No vulnerable population selected. Participants are adults with minimum age 18 and maximum age 64. Informed consent documents are listed (document 'Suostumusasiakirjat'); assent is not applicable..
- Pregnancy Exclusion
- Pregnancy
- Vulnerable Population
- No vulnerable population selected. Participants are adults with minimum age 18 and maximum age 64. Informed consent documents are listed (document 'Suostumusasiakirjat'); assent is not applicable.
Inclusion criteria
- {"criterion_text":"- Hoarseness that starts during or after flu symptoms and has lasted for less than three weeks"}
- {"criterion_text":"- Fluency in Finnish language"}
- {"criterion_text":"- Minimum age of 18 years and maximum age of 64 years"}
- {"criterion_text":"- Vocal professionals or those studying to become one"}
Exclusion criteria
- {"criterion_text":"- hypersensitivity to the prednisolone"}
- {"criterion_text":"- Contraindication to prednisolone (tuberculosis, acute psychosis, gastric or duodenal ulcer)."}
- {"criterion_text":"- Fungal and/or bacterial laryngitis"}
- {"criterion_text":"- Significant voice symptoms before laryngitis"}
- {"criterion_text":"- Fever (over 38C)"}
- {"criterion_text":"- Pregnancy"}
- {"criterion_text":"- Breastfeeding"}
- {"criterion_text":"- Simultaneous oral bacterial, viral or fungal medication."}
Endpoints
Primary endpoints
- {"endpoint_text":"- The duration of the vocal symptoms","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Inflammatory findings of larynx (especially in vocal cords) in laryngoscopy","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 70
- Recruitment Window Months
- 61
- Consent Approach
- Informed consent obtained from participants. Minimum age requirement 18 and maximum 64; fluency in Finnish required. Subject information and informed consent form available (document 'Suostumusasiakirjat').
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 70
Finland
- Earliest CTIS Part Ii Submission Date
- 23-02-2024
- Latest Decision Or Authorization Date
- 29-10-2024
- Processing Time Days
- 249
- Number Of Sites
- 1
- Number Of Participants
- 70
Sites
- Site Name
- HUS-Yhtymae
- Department Name
- Department of Phoniatrics, Helsinki University Hospital
- Principal Investigator Name
- Annika Laaksonen
- Principal Investigator Email
- annika.laaksonen@hus.fi
- Contact Person Name
- Annika Laaksonen
- Contact Person Email
- annika.laaksonen@hus.fi
- Number Of Participants
- 70
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
- Prednisolon 20 mg tabletit
- Active Substance
- PREDNISOLONE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised (marketing authorisation number 12104 in FI)
- Starting Dose
- 20 mg
- Maximum Dose
- 50 mg/day (max total 140 mg)
- Investigational Product Name
- White, flat round, uncoated tablet. Diameter 9 mm.
- Modality
- Other
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