Tolerability and Acceptance of Two Oral Hydrocortisone Compounding Formulation for Pediatrics

NCT06435481 | Not Yet Recruiting Phase 4

• 2 other identifiers: HIDROGUM212021-001069-20
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adrenal Insufficiency

Outcome Measures

Primary Outcomes (1)

• Tolerability and acceptance of the two compounded oral hydrocortisone formulations

  Tolerability will be assessed using a five-point questionnaire, while acceptability will be measured using the hedonic facial scale.

  6 months

Secondary Outcomes (1)

• Efficacy, compliance and safety of each hydrocortisone formulation

  6 months

Study Arms (2)

Chewable Tablet Group

EXPERIMENTAL

Group of patients receiving a new hydrocortisone formulation in the form of chewable tablets. Patients in this group will take the 3D printed chewable tablets orally for a duration of three months.

Drug: 3D printed chewable formulation of hydrocortisone

Oral Suspension Group

ACTIVE COMPARATOR

Group of patients receiving the standard hydrocortisone formulation in the form of an oral solution. Patients in this group will orally ingest the solution over a period of three months.

Drug: Oral suspension of hydrocortisone

Interventions

3D printed chewable formulation of hydrocortisone DRUG

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.

Chewable Tablet Group

Oral suspension of hydrocortisone DRUG

Administration of a standard hydrocortisone oral suspension. The solution, based on simple syrup, contains 1mg of hydrocortisone per milliliter.

Oral Suspension Group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

MeSH Terms

Conditions

Adrenal Insufficiency

Condition Hierarchy (Ancestors)

Adrenal Gland Diseases; Endocrine System Diseases

Study Officials

• Hospital Universitari Vall d'Hebron

  Hospital Vall d'Hebron

  STUDY CHAIR

Central Study Contacts

Carlos Javier Parramón Teixidó

CONTACT

+3492746017; carlosjavier.parramon@vallhebron.cat

Hospital Universitari Vall d'Hebron Research Institute

CONTACT

+34934894010; ceic@vhir.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 30, 2024
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)