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Tolerability and Acceptance of Two Oral Hydrocortisone Compounding Formulation for Pediatrics
Sponsor: Hospital Universitari Vall d'Hebron Research Institute
Summary
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.
Key Details
Gender
All
Age Range
6 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
35
Start Date
2024-09
Completion Date
2026-09
Last Updated
2024-05-30
Healthy Volunteers
No
Conditions
Interventions
3D printed chewable formulation of hydrocortisone
Administration of a novel hydrocortisone formulation provided as chewable tablets. Each tablet, manufactured with a volume dosing device (3D printer), contains a precise dosage of hydrocortisone.
Oral suspension of hydrocortisone
Administration of a standard hydrocortisone oral suspension. The solution, based on simple syrup, contains 1mg of hydrocortisone per milliliter.
Locations (1)
Hospital Universitari Vall d'Hebron
Barcelona, Spain