Tolerability and acceptance of two oral hydrocortisone medications for Pediatrics

Phase 1

• Conditions: Adrenal hyperplasia or isolated primary adrenal insufficiency or panhypopituitarism (secondary or tertiary adrenal insufficiency); Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2021-001069-20-ES
• Lead Sponsor: Vall d'Hebron Hospital Universitari

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-12
• Last Update Posted: 17 January 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

- 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)
Are the trial subjects under 18? yes
Number of subjects for this age range: 35
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified