Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06435481
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-04-29
Brief Title:
Tolerability and Acceptance of Two Oral Hydrocortisone Compounding Formulation for Pediatrics
Sponsor:
Hospital Universitari Vall dHebron Research Institute
Organization:
Hospital Universitari Vall dHebron Research Institute
Study Overview
Official Title:
Tolerability and Acceptance of Two Oral Hydrocortisone Compounding Formulation for Pediatrics
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study aims to evaluate the tolerability and acceptance of two compounded formulations of hydrocortisone prepared in the Vall dHebron University Hospital VHUH Pharmacy Service one an oral suspension and the other chewable tablets prepared using a volume dosing device M3DIMAKER 3D printer The main goal is to enhance patient care and adherence among pediatric patients
This prospective experimental study employs a randomized crossover design and will take place solely at VHUH Approximately 25-30 eligible patients diagnosed with adrenal hyperplasia isolated primary adrenal insufficiency or panhypopituitarism will be recruited Each patient will receive each hydrocortisone formulation for a period of 3 months totaling 6 months of treatment per patient All patients will receive the medication at their usual dose and both formulations to assess tolerability and acceptance
This prospective experimental study employs a randomized crossover design and will take place solely at VHUH Approximately 25-30 eligible patients diagnosed with adrenal hyperplasia isolated primary adrenal insufficiency or panhypopituitarism will be recruited Each patient will receive each hydrocortisone formulation for a period of 3 months totaling 6 months of treatment per patient All patients will receive the medication at their usual dose and both formulations to assess tolerability and acceptance
Detailed Description:
Adrenal insufficiency arises from inadequate synthesis of adrenal hormones with primary secondary or tertiary forms depending on the defects location-adrenal pituitary or hypothalamic Hydrocortisone 17-Hydroxycorticosterone is the preferred cortisol replacement
Pediatric hydrocortisone formulations are not commercially available in any presentation Consequently compounded formulations are prepared as standard practice Vall dHebron University Hospitals Pharmacy Service currently provides a liquid hydrocortisone formulation for these patients While liquid formulations are often preferred due to their better dose adjustment and improved acceptability by pediatric patients they have limitations such as shorter shelf life possible special storage conditions and taste problems due to bitter active ingredients In some cases particularly for chronic treatments with established and constant doses other options such as capsules may be considered Capsules offer longer stability longer expiration dates and do not require special storage conditions
In this context this study aims to determine the tolerability and acceptance of a new solid magistral formula in the form of chewable hydrocortisone tablets prepared using a volume dosing device M3DIMAKERTM 3D printer compared to the usually preferred liquid formulation Each of the formulations will be administered for three months Evaluating the results will allow us to improve assistance to pediatric patients by offering the formulation with better tolerability and acceptance The study will take place at Vall dHebron University Hospital led by the Pharmacy Service in collaboration with the Pediatric Endocrinology Service
Pediatric hydrocortisone formulations are not commercially available in any presentation Consequently compounded formulations are prepared as standard practice Vall dHebron University Hospitals Pharmacy Service currently provides a liquid hydrocortisone formulation for these patients While liquid formulations are often preferred due to their better dose adjustment and improved acceptability by pediatric patients they have limitations such as shorter shelf life possible special storage conditions and taste problems due to bitter active ingredients In some cases particularly for chronic treatments with established and constant doses other options such as capsules may be considered Capsules offer longer stability longer expiration dates and do not require special storage conditions
In this context this study aims to determine the tolerability and acceptance of a new solid magistral formula in the form of chewable hydrocortisone tablets prepared using a volume dosing device M3DIMAKERTM 3D printer compared to the usually preferred liquid formulation Each of the formulations will be administered for three months Evaluating the results will allow us to improve assistance to pediatric patients by offering the formulation with better tolerability and acceptance The study will take place at Vall dHebron University Hospital led by the Pharmacy Service in collaboration with the Pediatric Endocrinology Service
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-001069-20 | EUDRACT_NUMBER | None | None |