Tolerability and Acceptance of Two Oral Hydrocortisone Compounding Formulation for Pediatrics

The study aims to evaluate the tolerability and acceptance of two compounded formulations of hydrocortisone prepared in the Vall d'Hebron University Hospital (VHUH) Pharmacy Service: one, an oral suspension and the other, chewable tablets prepared using a volume dosing device (M3DIMAKER 3D printer). The main goal is to enhance patient care and adherence among pediatric patients. This prospective, experimental study employs a randomized, crossover design and will take place solely at VHUH. Approximately 25-30 eligible patients diagnosed with adrenal hyperplasia, isolated primary adrenal insufficiency, or panhypopituitarism will be recruited. Each patient will receive each hydrocortisone formulation for a period of 3 months, totaling 6 months of treatment per patient. All patients will receive the medication at their usual dose and both formulations to assess tolerability and acceptance.

NCT Number	NCT06435481
Lead Sponsor	Hospital Universitari Vall d'Hebron Research Institute
Conditions	Adrenal Insufficiency
Enrollment	35 participants
Start Date	2024-09
Primary Completion	2025-09 (estimated)
Study Completion	2026-09 (estimated)
Updated on ClinicalTrials.gov	2024-05-30