Tolerability and acceptance of two oral hydrocortisone medications for Pediatrics

Tolerability and acceptance of two oral hydrocortisone compounding formulation for pediatrics

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-001069-20-ES

Enrollment

Registered

2021-08-12

Start date

2022-01-12

Completion date

Unknown

Last updated

2022-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Trade Name: Hidrocortisona base (17-Hidroxicorticosterona) Product Name: Hidrocortisona Base Acofarma Product Code: 1150552 Pharmaceutical Form: INN or Proposed INN: hydrocortisone Other descriptive

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Outpatients of both sexes, = 6 years of age without swallowing problems and up to 17 years, at the time of signing the informed consent document by parent (s) or guardian (s) and / or patients. - Diagnosis of adrenal hyperplasia or isolated primary adrenal insufficiency or panhypopituitarism (secondary or tertiary adrenal insufficiency) Are the trial subjects under 18? yes Number of subjects for this age range: 35 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: -Known hypersensitivity to any of the excipients in the hydrocortisone compounding. -Any disorder or situation (decompensation) that, in the opinion of the medical researcher, poses a risk of not complying with the treatment.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the tolerability and acceptance of the two hydrocortisone compounding formulation prepared in the Hospital Pharmacy Service.;Secondary Objective: To evaluate adherence to treatment.;Primary end point(s): The sensory acceptability of the formulation will be evaluated taking into account the shape, taste and color of the different hydrocortisone magisterial formulas independently for each attribute. The chewable formulation of hydrocortisone will be changed color and flavor every 15 days in order to select the best presentation of the compounding formulation and improve adherence to the prescribed treatment. Acceptability will be measured through the hedonic facial scale. This type of test has been carried out with children, who have the possibility of evaluating whether or not they like the product without considering language, social condition, or geographical or cultural background. Tolerability will be determined by asking on a five-point hedonic facil scale: if the patient refuses the medication, spits the medication, and if they are willing to take the medication again in the future.;Timepoint(s) of evaluation of this end point: Monthly: In each medical visits	—

Measure

Time frame

Main Objective: To evaluate the tolerability and acceptance of the two hydrocortisone compounding formulation prepared in the Hospital Pharmacy Service.;Secondary Objective: To evaluate adherence to treatment.;Primary end point(s): The sensory acceptability of the formulation will be evaluated taking into account the shape, taste and color of the different hydrocortisone magisterial formulas independently for each attribute. The chewable formulation of hydrocortisone will be changed color and flavor every 15 days in order to select the best presentation of the compounding formulation and improve adherence to the prescribed treatment. Acceptability will be measured through the hedonic facial scale. This type of test has been carried out with children, who have the possibility of evaluating whether or not they like the product without considering language, social condition, or geographical or cultural background. Tolerability will be determined by asking on a five-point hedonic facil scale: if the patient refuses the medication, spits the medication, and if they are willing to take the medication again in the future.;Timepoint(s) of evaluation of this end point: Monthly: In each medical visits

—

Secondary

Measure	Time frame
Secondary end point(s): Adherence will be estimated with the medication count and the pharmacy dispensing record.;Timepoint(s) of evaluation of this end point: Monthly: In each of the pharmacy visits to collect the medication.	—

Countries

Spain

Contacts

Public ContactServei de Farmacia

Vall d'Hebron Hospital Universitari

+3493489 30006117

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026