Tolerability and Acceptance of Two Oral Hydrocortisone Compounding Formulation for Pediatrics

Launched by HOSPITAL UNIVERSITARI VALL D'HEBRON RESEARCH INSTITUTE · May 24, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at two different ways to give hydrocortisone, a medication used to treat adrenal insufficiency, to children and teenagers. The trial will test an oral suspension (a liquid) and chewable tablets that are specially made at a hospital pharmacy. The goal is to see which form is more tolerable and accepted by young patients, helping to improve their treatment experience and make it easier for them to take their medicine regularly.

To participate, children and teenagers aged 6 to 17 who have specific conditions like adrenal hyperplasia or adrenal insufficiency may be eligible. Participants will try both forms of hydrocortisone for a total of six months, with each formulation being tested for three months. Throughout the study, they will take their usual dose of the medication. It's important to note that this trial is not yet recruiting participants, and individuals with certain allergies or health issues that might affect their ability to follow the treatment plan will not be included.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Outpatients of both sexes, ≥ 6 years old without swallowing problems and up to 17 years old, 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:
• • Known hypersensitivity to any of the excipients in the formulation of hydrocortisone.
• • Any disorder or situation (decompensation) that, in the opinion of the investigating physician, poses a risk of non-compliance with the treatment.