AuthorisedTherapeutic use (Phase IV)Interventional

Tolerability and acceptance study of two oral hydrocortisone magistral formulations for pediatrics

This study is all about making medicine easier for children to take. We're looking at two different ways to give hydrocortisone, a medicine that replaces a natural hormone called cortisol that some children don't make enough of. This hormone is vital for lots of body functions. The study wants to find out which of these two forms children prefer and find easier to swallow. This is important because if medicine tastes or feels better, children are more likely to take it properly, which helps them stay healthy. This research aims to improve how children receive their hydrocortisone medication, making their treatment journey a little bit smoother for them and their families.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca

Enrolment target

Start

31 Oct 2024

Adrenal hyperplasia or isolated primary adrenal insufficiency or panhypopituitarism (secondary or tertiary adrenal insufficiency).

What is this study about?

This study focuses on a vital medicine called hydrocortisone. Hydrocortisone is a type of steroid medicine that's very similar to a natural hormone called cortisol, which our bodies usually make. Some children, however, don't make enough of this important hormone themselves. This can happen due to certain conditions like congenital adrenal hyperplasia, or problems with their adrenal glands or a part of the brain called the pituitary gland.

When a child doesn't produce enough cortisol, they need to take hydrocortisone medicine to replace it. This is really important because cortisol helps our bodies manage stress, keep our blood sugar normal, and fight off infections. Without enough of it, children can become very unwell. So, giving them the right amount of hydrocortisone is essential for their health and well-being.

The main goal of this particular study is to find out which of two different types of hydrocortisone medicine, specifically made for children, is the most user-friendly. We want to understand if one tastes better, is easier to swallow, or simply more pleasant for children to take. This kind of research helps doctors and pharmacists choose the best way to give children their medicine, making their treatment journey as comfortable and effective as possible. It's all about making sure children get the medicine they need without too much fuss.

Key takeaways

This study aims to find the best way for children to take hydrocortisone medicine.
It's for children who need hydrocortisone because their body doesn't make enough cortisol.
Your child will try two different preparations of hydrocortisone.
Your feedback will help improve medicine for other children.
Participation will not change your child's existing treatment plan.
You can withdraw your child from the study at any time.

Who may be eligible?

This study is open to children of all ages who need to take hydrocortisone medication. Doctors usually prescribe hydrocortisone for children who have conditions where their body doesn't make enough of a natural hormone called cortisol. This might be due to problems with their adrenal glands (which produce cortisol) or their pituitary gland (which tells the adrenal glands what to do).

If your child has been diagnosed with a condition like adrenal hyperplasia, or conditions where their adrenal system isn't working as it should, then they might be suitable for this study. The study team will check their medical information to see if they meet all the specific requirements.

Both boys and girls are welcome to take part. The main thing is that your child is currently taking hydrocortisone or needs to start taking it, and that their doctors think this study is a good fit for their treatment plan.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your child currently taking hydrocortisone medicine?
Does your child have a condition where their body doesn't produce enough cortisol?
Has a doctor told you that your child has adrenal hyperplasia or similar adrenal gland problems?
Are you able to attend a short appointment (or two) for your child to taste the medication and give feedback?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, it will involve trying out two different forms of hydrocortisone medicine. The study team will carefully guide you through the process, explaining everything clearly. The main part of taking part will be for your child to taste and try each of the two hydrocortisone preparations. You and your child will then be asked to give your opinions, perhaps by answering some simple questions or through a short interview, about which one they preferred and why.

There won't be any extra hospital visits or complicated medical tests involved specifically for this study. The main focus is on your child's experience with the medication. The total time commitment for the study is expected to be quite short, likely just one or two sessions to test the medicines and give feedback. You and your child will continue their regular hydrocortisone treatment as prescribed by their doctor throughout the study.

Potential risks and benefits

Taking part in this study may offer several potential benefits. By sharing your child's experience, you'll be helping doctors and pharmacists make better choices about how to prepare hydrocortisone for other children in the future, potentially making medicine-taking easier for many. Your child also might find one of the new formulations more pleasant than their current medicine. As this study looks at different ways to take an existing medicine rather than a new one, serious risks are not expected. The study will not change your child's dose or treatment plan. You have the right to withdraw your child from the study at any time, for any reason, without it affecting their medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Spain

Common questions

What is hydrocortisone and why do children need it?

Hydrocortisone is a medicine that replaces a natural hormone called cortisol, which some children's bodies don't make enough of. This hormone is vital for growth, energy, and fighting off illness.

What kind of hydrocortisone are you testing?

We are looking at two different forms of hydrocortisone that are prepared especially for children, focusing on how easy and pleasant they are to take.

Will my child's regular medicine change if they join?

No, your child's usual hydrocortisone dose and treatment plan will not change because of this study. They will simply try different forms of the medicine they already take.

How long will my child need to be in the study?

The study is expected to be quite short, probably involving one or two sessions to test the medicines and give your feedback.

Are there any side effects from this study?

Because we're looking at different forms of approved hydrocortisone, serious side effects are not expected. The focus is on how easy they are to take, not on new medical effects.