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Can a sprinkle of hydrocortisone replace tablets for babies with adrenal insufficiency?

NCT ID NCT02720952

Disease control Sponsor: Neurocrine UK Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Oct 02, 2026 · Last updated Oct 02, 2026

Summary

Researchers are testing Infacort, a dry granule form of hydrocortisone, in children under 6 years old who have adrenal insufficiency and need replacement therapy. The study enrolls 24 children in three age groups, starting with ages 2 to under 6, then babies 28 days to under 2 years, and finally newborns up to 28 days. Doctors give the granules and measure blood cortisol levels over four hours to see how well the drug is absorbed, and they ask parents about the taste. An independent committee reviews safety data before each new age group joins.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Infacort, a dry granule form of hydrocortisone
What this could lead to
If it works, this could give families a child-friendly hydrocortisone option that is easier to swallow and dose than standard tablets.
What could go wrong
The study is small, with 24 children, and only measures how the body absorbs the drug and how it tastes. It cannot show long-term benefits or rare side effects, and results in babies may differ from older children.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

24 people

The number who actually took part.

Start date

Mar 2015

Finished

Jul 2016

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 week to 6 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male and female children less than 6 years of age. 2. A diagnosis of adrenal insufficiency as confirmed by an inappropriately low cortisol usually with other supporting tests. 3. Receiving appropriate adrenocortical replacement therapy (hydrocortisone with/without fludrocortisone). 4. Adequately hydrated and nourished. 5. Ability of parents/carers to understand and give written Informed Consent Exclusion Criteria: 1. Clinically evident acute adrenal insufficiency (adrenal crisis). 2. Inability of the child to take oral therapy. 3. Concomitant therapy (other than that required to treat adrenal insufficiency, Vitamin D, Fluoride, Thyroxine and growth hormone). 4. Subjects with clinical signs of acute infection or fever on Day 1. 5. Any surgical or medical condition which in the opinion of the investigator may place the subject at higher risk from his/her participation in the study. 6. Parents/carers of subjects unwilling to consent to saving and propagation of pseudonymised medical data for study reasons. 7. Subjects who are dependent on the investigator or the sponsor.

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Conditions

The condition(s) this trial relates to.

adrenocortical insufficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adrenal insufficiency

Contacts and locations

Locations

  • Charité-Universitätsmedizin Berlin, CVK

    Berlin, 13353, Germany

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