Study on the Tolerability and Acceptance of Oral Hydrocortisone for Children with Adrenal Hyperplasia or Adrenal Insufficiency

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What is this study about?

This clinical trial is focused on studying the tolerability and acceptance of two oral medications containing hydrocortisone for children. The diseases being studied include adrenal hyperplasia, primary adrenal insufficiency, and panhypopituitarism, which are conditions that affect hormone production in the body. The treatment involves two different formulations of hydrocortisone, which is a medication used to replace hormones that the body is not producing in sufficient amounts.

The purpose of the study is to evaluate how well children tolerate and accept these two hydrocortisone formulations. The study will involve children aged 6 to 17 years who have been diagnosed with one of the mentioned conditions. Participants will receive one of the two hydrocortisone formulations prepared by the Hospital Pharmacy Service. The study will assess how the children respond to the medication over a period of time, focusing on how acceptable the medication is in terms of taste and ease of use.

Throughout the study, the children will be monitored to ensure their safety and to gather information on how they react to the medication. The study aims to provide valuable insights into the best ways to administer hydrocortisone to children with these conditions, ensuring that the treatment is both effective and easy for them to take.

1 joining the study

Upon joining the study, the patient must be between 6 and 17 years old and have a diagnosis of adrenal hyperplasia, isolated primary adrenal insufficiency, or panhypopituitarism. The patient should not have any swallowing problems.

The informed consent document must be signed by the parent(s) or guardian(s) and/or the patient.

2 medication administration

The patient will receive two oral medications containing hydrocortisone. These medications are prepared in the hospital pharmacy.

The purpose is to evaluate how well the patient tolerates and accepts these medications.

3 evaluation of tolerability and acceptance

The main objective is to assess the sensory acceptability of the hydrocortisone formulations. This involves understanding how the patient perceives the taste, texture, and overall experience of taking the medication.

4 trial duration

The trial is expected to start recruiting patients on January 1, 2025, and is estimated to end on January 1, 2026.

Who Can Join the Study?

Patients must be outpatients, meaning they do not need to stay overnight in the hospital.
Both boys and girls can participate.
Patients must be at least 6 years old and no older than 17 years old.
Patients should not have any problems with swallowing.
A parent or guardian must sign a document called an informed consent, which means they agree to let the patient participate in the study.
Patients must have a diagnosis of one of the following conditions:
- Adrenal hyperplasia: A condition where the adrenal glands, which are small organs on top of the kidneys, are larger than normal.
- Isolated primary adrenal insufficiency: A condition where the adrenal glands do not produce enough hormones.
- Panhypopituitarism: A condition where the pituitary gland, a small gland in the brain, does not produce enough hormones, leading to secondary or tertiary adrenal insufficiency.

Who Cannot Join the Study?

Patients with adrenal hyperplasia cannot participate. This is a condition where the adrenal glands, which are small glands on top of the kidneys, are larger than normal.
Patients with isolated primary adrenal insufficiency are excluded. This means the adrenal glands do not produce enough hormones on their own.
Patients with panhypopituitarism are not eligible. This is a condition where the pituitary gland, a small gland at the base of the brain, does not produce enough of certain important hormones.
Patients with secondary or tertiary adrenal insufficiency cannot join. This means the adrenal glands do not produce enough hormones due to problems with the pituitary gland or the hypothalamus, which is a part of the brain that controls the pituitary gland.

Where you can join this trial?

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Site Name	City	Country	Status
Huwebxsv Vjaf dyxmoztt	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not yet recruiting	01.01.2025

Trial locations

Hydrocortisone: This medication is a type of steroid used to reduce inflammation in the body. In this trial, two different formulations of hydrocortisone are being tested to see how well they are tolerated and accepted by pediatric patients. The goal is to find out which formulation is more suitable for children, ensuring it is both effective and easy for them to take.

Investigated diseases:

Adrenal Hyperplasia – This condition involves the enlargement of the adrenal glands, which are located above the kidneys. It often results from genetic mutations affecting hormone production, leading to an imbalance in hormones like cortisol and aldosterone. Symptoms can include early signs of puberty, rapid growth during childhood, and irregular menstrual cycles in females. Over time, it may cause issues with blood pressure, metabolism, and stress response.

Isolated Primary Adrenal Insufficiency – This disease occurs when the adrenal glands do not produce enough hormones, particularly cortisol and aldosterone. It can lead to symptoms such as fatigue, muscle weakness, weight loss, and low blood pressure. The condition progresses with increasing difficulty in managing stress and maintaining normal blood sugar levels. It may also cause darkening of the skin and salt cravings.

Panhypopituitarism – This condition is characterized by the underproduction of hormones by the pituitary gland, affecting various bodily functions. It can lead to symptoms like fatigue, weakness, and decreased appetite. As the disease progresses, it may impact growth, reproductive functions, and the body’s ability to respond to stress. It can also cause low blood pressure and changes in body composition.

Trial ID:

2024-519149-31-00

Protocol code:

HIDROGUM21

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Tolerability and Acceptance of Oral Hydrocortisone for Children with Adrenal Hyperplasia or Adrenal Insufficiency

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?