Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruiting

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

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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 trial?

8 criteria

  • 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 trial?

4 criteria

  • 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.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

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.

What is already known about the treatment

Hydrocortisone – This medication is administered orally and is being studied in a clinical trial to assess its tolerability and acceptance in pediatric patients. It is currently used in medicine to treat conditions such as adrenal hyperplasia, isolated primary adrenal insufficiency, and panhypopituitarism, which includes secondary or tertiary adrenal insufficiency. Hydrocortisone works by mimicking the action of cortisol, a hormone naturally produced by the adrenal glands, helping to regulate various bodily functions. It belongs to the pharmacological class of corticosteroids, which are used to reduce inflammation and modify the body's immune response.

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 detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2024-519149-31-00Protocol codeHIDROGUM21Estimated enrolment35 patientsSponsorFundacio Hospital Universitari Vall D’Hebron Institut De Recerca

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).