Clinical trial • Phase IV • Endocrinology
HYDROCORTISONE PH. EUR. for Adrenal hyperplasia | Primary adrenal insufficiency | Panhypopituitarism (secondary or tertiary adrenal insufficiency)
Phase IV trial of HYDROCORTISONE PH. EUR. for Adrenal hyperplasia | Primary adrenal insufficiency | Panhypopituitarism (secondary or tertiary adrenal insu…
Overview
- Trial Therapeutic Area
- Endocrinology
- Trial Disease
- Adrenal hyperplasia | Primary adrenal insufficiency | Panhypopituitarism (secondary or tertiary adrenal insufficiency)
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 25-10-2024
- First CTIS Authorization Date
- 31-10-2024
Trial design
HYDROCORTISONE PH. EUR. (oral). Dose unit: mg/m2; max daily dose 12 mg/m2; max total dose 1080 mg/m2; specific schedule not stated in available data.-controlled Phase IV trial across 1 site in Spain.
- Comparator
- HYDROCORTISONE PH. EUR. (oral). Dose unit: mg/m2; max daily dose 12 mg/m2; max total dose 1080 mg/m2; specific schedule not stated in available data.
- Target Sample Size
- 35
Eligibility
Recruits 35 paediatric patients.
- Vulnerable Population
- Includes minors aged 6 to 17 years; informed consent must be signed by parent(s) or guardian(s) and/or patients (as stated in inclusion criteria). Subject information and informed consent forms for minor patients and for parents/legal representatives are provided (documents labelled _ESP indicate Spanish-language versions).
Inclusion criteria
- {"criterion_text":"- Outpatients of both sexes, ≥ 6 years of age without swallowing problems and up to 17 years, at the time of signing the informed consent document by parent (s) or guardian (s) and / or patients.\n- Diagnosis of adrenal hyperplasia or isolated primary adrenal insufficiency or panhypopituitarism (secondary or tertiary adrenal insufficiency)."}
Exclusion criteria
- {"criterion_text":"- Known hypersensitivity to any of the excipients in the hydrocortisone compounding.\n- Any disorder or situation (decompensation) that, in the opinion of the medical researcher, poses a risk of not complying with the treatment."}
Endpoints
Primary endpoints
- {"endpoint_text":"- The sensory acceptability of the formulation.","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 35
- Recruitment Window Months
- 12
- Consent Approach
- Informed consent to be signed by parent(s) or legal guardian(s) and/or by the patients themselves as applicable (inclusion criterion states consent signing by parent(s) or guardian(s) and/or patients). Subject information and informed consent forms are available for minor patients and for parents/legal representatives (documents labeled with _ESP indicate Spanish-language versions).
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 35
Spain
- Earliest CTIS Part Ii Submission Date
- 21-10-2024
- Latest Decision Or Authorization Date
- 31-10-2024
- Processing Time Days
- 10
- Number Of Sites
- 1
- Number Of Participants
- 35
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Pharmacy service
- Contact Person Name
- Carlos Javier Parramón
- Contact Person Email
- carlosjavier.parramon@vallhebron.cat
- Number Of Participants
- 35
Sponsor
Primary sponsor
- Full Name
- Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
- Organisation Type
- Laboratory/Research/Testing facility
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- HYDROCORTISONE PH. EUR.
- Active Substance
- HYDROCORTISONE PH. EUR.
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Maximum Dose
- Max daily dose 12 mg/m2; max total dose 1080 mg/m2
- Investigational Product Name
- HYDROCORTISONE PH. EUR.
- Active Substance
- HYDROCORTISONE PH. EUR.
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Maximum Dose
- Max daily dose 12 mg/m2; max total dose 1080 mg/m2
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