Overview
Sponsor-declared trial summary
Adrenal hyperplasia or isolated primary adrenal insufficiency or panhypopituitarism (secondary or tertiary adrenal insufficiency).
To evaluate the tolerability and acceptance of the two hydrocortisone compounding formulation prepared in the Hospital Pharmacy Service.
Key facts
- Sponsor
- Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hormonal diseases [C19]
- Decision date (initial)
- 2024-10-31
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-519149-31-00
- EudraCT number
- 2021-001069-20
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
To evaluate the tolerability and acceptance of the two hydrocortisone compounding formulation prepared in the Hospital Pharmacy Service.
Secondary objectives 1
- To evaluate adherence to treatment.
Conditions and MedDRA coding
Adrenal hyperplasia or isolated primary adrenal insufficiency or panhypopituitarism (secondary or tertiary adrenal insufficiency).
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- 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.
- Diagnosis of adrenal hyperplasia or isolated primary adrenal insufficiency or panhypopituitarism (secondary or tertiary adrenal insufficiency).
Exclusion criteria 2
- Known hypersensitivity to any of the excipients in the hydrocortisone compounding.
- Any disorder or situation (decompensation) that, in the opinion of the medical researcher, poses a risk of not complying with the treatment.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The sensory acceptability of the formulation.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB171070 · Substance
- Active substance
- Hydrocortisone Ph. Eur.
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 12 mg/m2 milligram(s)/square meter
- Max total dose
- 1080 mg/m2 milligram(s)/square meter
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- Yes
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Formula magistral
Comparator 1
SUB171070 · Substance
- Active substance
- Hydrocortisone Ph. Eur.
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 12 mg/m2 milligram(s)/square meter
- Max total dose
- 1080 mg/m2 milligram(s)/square meter
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- Yes
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Formula magristal
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
- Sponsor organisation
- Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
- Address
- Passeig De La Vall D'Hebron 119-129
- City
- Barcelona
- Postcode
- 08035
- Country
- Spain
Scientific contact point
- Organisation
- Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
- Contact name
- Carlos Javier Parramón-Teixidó
Public contact point
- Organisation
- Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
- Contact name
- Carlos Javier Parramón-Teixidó
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 35 | 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 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol EU CT 2024-519149-31-00_for publication | 6 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_minor patients_ESP | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_parents or legal representative_ESP | 6 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Hidrocortisona Base_for publication | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Hidrocortisona Base_for publication | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-25 | Spain | Acceptable 2024-10-31
|
2024-10-31 |