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Hydrocortisone Ph. Eur.

This article discusses a clinical trial investigating the use of Hydrocortisone Ph. Eur. in pediatric patients with adrenal disorders. The study aims to assess the tolerability and acceptance of two different oral hydrocortisone formulations prepared by hospital pharmacies. This research is particularly important for children with adrenal hyperplasia, primary adrenal insufficiency, or panhypopituitarism, as it seeks to improve their treatment options and potentially enhance adherence to medication.

Table of Contents

What is Hydrocortisone?

Hydrocortisone, also known as 17-Hydroxycorticosterone, is a medication that belongs to a class of drugs called corticosteroids. It is a synthetic version of cortisol, a hormone naturally produced by the adrenal glands[1]. Hydrocortisone is used to treat various conditions related to adrenal gland disorders, particularly in children who cannot produce enough of this hormone on their own.

Medical Conditions Treated

Hydrocortisone is used to treat several medical conditions related to adrenal gland function. These include:

  • Adrenal hyperplasia: A group of inherited disorders affecting the adrenal glands, causing them to produce abnormal levels of certain hormones.
  • Primary adrenal insufficiency: Also known as Addison’s disease, where the adrenal glands don’t produce enough cortisol.
  • Panhypopituitarism: A condition where the pituitary gland doesn’t produce enough hormones, leading to secondary or tertiary adrenal insufficiency[1].

These conditions can significantly impact a child’s growth, development, and overall health, making proper treatment crucial.

Formulations for Children

Hydrocortisone for pediatric use comes in special formulations designed to be more suitable for children. The ongoing research is focusing on two main types:

  1. Chewable tablets: These are tablets that can be chewed, making them easier for children to take[1].
  2. Oral suspension: This is a liquid form of the medication that can be easier for younger children to swallow[1].

Both of these formulations are considered “magistral” or compounded, which means they are specially prepared in a hospital pharmacy to meet the specific needs of pediatric patients[1].

Dosage and Administration

The dosage of hydrocortisone is carefully calculated based on the child’s body surface area. The maximum daily dose in the study is 12 mg/m² (milligrams per square meter of body surface area)[1]. The total maximum dose over the treatment period is 1080 mg/m².

Hydrocortisone is typically administered orally, either as chewable tablets or as a liquid suspension. The treatment period in the study lasts for up to 3 months[1].

Eligibility for Treatment

To be eligible for hydrocortisone treatment in the study, patients must meet certain criteria:

  • Be between 6 and 17 years old
  • Have no swallowing problems
  • Be diagnosed with adrenal hyperplasia, primary adrenal insufficiency, or panhypopituitarism
  • Not have any known hypersensitivity to the ingredients in the hydrocortisone formulation
  • Be able to comply with the treatment regimen[1]

Potential Side Effects

While the study focuses on tolerability and acceptance, it’s important to note that all medications can have side effects. Common side effects of hydrocortisone may include stomach upset, headache, dizziness, or changes in mood. Always discuss potential side effects with your healthcare provider.

Ongoing Research

A clinical trial is currently underway to evaluate the tolerability and acceptance of two different hydrocortisone formulations for children. The main objectives of this study are:

  1. To assess how well children tolerate the medication
  2. To evaluate the acceptance of the two different formulations (chewable tablets and oral suspension)
  3. To measure adherence to the treatment regimen[1]

This research is crucial for improving treatment options for children with adrenal gland disorders, potentially leading to better management of their conditions and improved quality of life.

Aspect Details
Study Type Phase IV, low intervention clinical trial
Main Objective Evaluate tolerability and acceptance of two hydrocortisone formulations
Secondary Objective Evaluate adherence to treatment
Target Population Pediatric patients (6-17 years) with adrenal disorders
Formulations Tested Chewable tablets and oral suspension
Active Ingredient Hydrocortisone Ph. Eur.
Maximum Daily Dose 12 mg/m²
Treatment Duration Up to 3 months
Primary Endpoint Sensory acceptability of the formulations

FAQ

  • What is the main goal of this clinical trial? The main goal is to evaluate the tolerability and acceptance of two different oral hydrocortisone formulations prepared in the Hospital Pharmacy Service for pediatric patients with adrenal disorders.
  • Who can participate in this study? Outpatients of both sexes, aged 6 to 17 years, without swallowing problems, who have been diagnosed with adrenal hyperplasia, isolated primary adrenal insufficiency, or panhypopituitarism (secondary or tertiary adrenal insufficiency).
  • What are the two formulations being tested? The study is testing two formulations: chewable tablets and an oral suspension, both made from the active ingredient hydrocortisone base.
  • How long does the treatment period last? The maximum treatment period for this study is 3 months.
  • What is the secondary objective of the trial? The secondary objective of the trial is to evaluate adherence to treatment, which means assessing how well patients stick to their prescribed medication regimen.

Ongoing Clinical Trials on Hydrocortisone Ph. Eur.

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

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

Glossary

  • Adrenal hyperplasia: A group of genetic disorders affecting the adrenal glands, causing them to produce abnormal levels of certain hormones.
  • Primary adrenal insufficiency: A condition where the adrenal glands don't produce enough hormones, particularly cortisol and aldosterone.
  • Panhypopituitarism: A condition where the pituitary gland doesn't produce enough hormones, affecting various bodily functions.
  • Hydrocortisone: A steroid hormone used to treat various conditions, including adrenal insufficiency, by replacing the cortisol that the body cannot produce on its own.
  • Compounding formulation: A custom preparation of a medication made by a pharmacist to meet specific patient needs, often when commercial products are not available.
  • Sensory acceptability: How well a patient tolerates the taste, smell, and texture of a medication, which can affect their willingness to take it regularly.
  • Adherence to treatment: The extent to which a patient follows their prescribed treatment plan, including taking medications as directed.
  • Low intervention clinical trial: A type of clinical trial that poses minimal risks to participants and uses approved medications or well-established treatment methods.

References

  1. http://clinicaltrials.eu/trial/study-on-the-tolerability-and-acceptance-of-oral-hydrocortisone-for-children-with-adrenal-hyperplasia-or-adrenal-insufficiency/