Trials Sponsors Conditions Drugs Pricing

Conditions

adrenal insufficiency

Outcome Measures

Primary Outcomes (1)

The GMR of the AUC of orally administered hydrocortisone ODF compared to the AUC of hydrocortisone oral tablets.

Secondary Outcomes (6)

Descriptive PK parameters of all IMP formu-lations, e.g. AUC, Cmax, the time to Cmax (tmax), and the apparent volume of distribu-tion (Vz/F).
Correlation of concentrations of salivary cor-tisone and hydrocortisone with serum free cortisone and hydrocortisone.
Evaluation of palatability by assessing partic-ipants satisfaction and ease of administra-tion of hydrocortisone ODF.
Evaluation of frequency, severity, serious-ness, relatedness, expectedness, and out-come of AE under trial medication.
Evaluation of the concentration-time profiles of the following biomarkers after different hy-drocortisone formulations: o plasma ACTH as well as glucose and electrolytes (sodium, potassium) in blood gas analysis
+1 more secondary outcomes

Interventions

Acecort 5 mg FilmtablettenType not reported

2D printed Hydrocortisone orodispersible filmsType not reported

Acecort 1 mg FilmtablettenType not reported

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
Acecort 5 mg Filmtabletten
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry record
Formulated product
Acecort 1 mg Filmtabletten
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

Acecort 5 mg Filmtabletten
Named ingredient: Hydrocortisone
View registry record
Acecort 1 mg Filmtabletten
Named ingredient: Hydrocortisone
View registry record

Eligibility Criteria

Sexall

Age GroupsChild (0-17)

You may qualify if:

Participants meeting all of the following criteria will be considered for enrolment into the clinical trial: Written, personally signed and dated informed consent (by legal representatives) as well as pediatric assent (from participants, where appropriate) to participate in the trial prior to any trial-related interventions, in accordance with the International Conference on Harmo-nisation (ICH) GCP Guideline E6, and applicable regulations (CTR).
Be a female or male of 7 to 17 y inclusive at the time of signed informed consent/assent.

Sponsors & Collaborators

Universitaetsklinikum Heidelberg AöR
Type not reportedlead

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Study Sites (1)

Universitaetsklinikum Heidelberg AöR

Heidelberg, 69120, Germany

Kristine Chobanyan-Jürgens+4962215639572 kristine.chobanyan-juergens@med.uni-heidelberg.de

Central Study Contacts

Kristine Chobanyan-Jürgens

+4962215639572 kristine.chobanyan-juergens@med.uni-heidelberg.de

Study Design

Study Type: interventional
Phase: phase 1

Study Record Dates

First Submitted

June 22, 2026

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2026-526416-37-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-30 06:57:14 UTC

Locations

DE(1)

You may not qualify if:

Participants presenting with any of the following criteria will not be included in the clinical trial: 1. A person (either participant or legal representatives) who, in the opinion of the investigator, is unwilling or unable to adhere to the requirements of the trial.
A person (either participant or legal representatives) who is an employee of the Investiga-tor or sponsor or study site, with direct involvement in the proposed study or other studies under the direction of that Investigator or study site, as well as family members of the employees or the Investigator.
A person who is institutionalized pursuant to a court order or an order by a government agency or is in residential care institutions.
Any medical disorder that may require treatment or make the participant unlikely to fully complete the trial, or any condition that presents undue risk from the IMP or trial interven-tions.
Is at increased risk of developing adrenal crisis in the investigator’s opinion, based on, for example, repeated history of adrenal crisis in the past, prior history of adrenal crisis pre-cipitated by reducing glucocorticoid dose, recent episode(s), etc.
Pregnancy or breast feeding.
Late onset congenital adrenal hyperplasia.
Secondary adrenal insufficiency.
Treatment with other glucocorticoids (e.g. prednisolone, dexamethasone) or modified-re-lease hydrocortisone preparations (e.g. Efmody®).
History of malignancy, unless successfully treated with curative intent and considered to be cured.
Diabetes mellitus type 1, 2, or 3 (other specific types of diabetes) according to the ADA criteria [American Diabetes Association Professional Practice Committee, 2024].
Any acute or chronic illness or clinically relevant finding known or expected to modify ab-sorption, distribution, metabolism, or excretion of hydrocortisone.
Any known history of severe allergic or anaphylactic reactions to trial drugs, other drugs, food, or any other clinically significant allergies or hypersensitivity reactions.
A positive result in the drug screening test in urine at SCR.
Use of an IMP in another clinical trial within 30 d or 5 half-lives (whichever is longer) prior to the expected date of receiving the first dose of IMP in the current trial or active enrol-ment in another drug clinical trial.
+8 more criteria

Relative oral bioavailability and tolerability of hydrocortisone from 2-dimensionally printed orodispersible films in children and adolescents with primary adrenal insufficiency (REPLACE trial)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Locations

You may not qualify if:

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Locations

You may not qualify if: