Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04786873
Status:
COMPLETED
Last Update Posted:
2024-04-23
First Post:
2021-03-03
Brief Title:
A Research Study of How Well Macimorelin Works to Find Out if Children Have a Lack of Growth Hormone and How Safe it is
Sponsor:
AEterna Zentaris
Organization:
AEterna Zentaris
Study Overview
Official Title:
Multicenter Open Label Trial to Investigate the Efficacy and Safety of a Single Oral Dose of 10 mgkg Macimorelin Acetate as Growth Hormone Stimulation Test GHST in Pediatric Patients With Suspected Growth Hormone Deficiency GHD
Status:
COMPLETED
Status Verified Date:
2024-08
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:
DETECT
Brief Summary:
This research study will find out if a new growth hormone stimulation test is safe and works as well as other tests to diagnose growth hormone deficiency GHD in children The stimulation test will use a new growth hormone stimulating substance called macimorelin By now only adults in the USA can get this new stimulation test The results of this study are expected to help children and teenagers with suspected GHD to get the macimorelin stimulation test
The macimorelin test will be compared to a clonidine and an arginine test Both are known standard stimulation tests Altogether two macimorelin tests are planned to be performed in the study to show how repeatable macimorelin tests results are under a set of similar conditions
The macimorelin test will be compared to a clonidine and an arginine test Both are known standard stimulation tests Altogether two macimorelin tests are planned to be performed in the study to show how repeatable macimorelin tests results are under a set of similar conditions
Detailed Description:
Each study participant patient will have 5 to 6 visits in total with the study doctor
The study will last for about 1 to 4 months dependent on how close the visits are done At the visits 2 3 4 and 5 the patient will get a stimulation test done and blood samples will be taken At those 4 visits the patient will have either to drink a macimorelin drink take some clonidine tablets or get an arginine infusion In total the patient will get 2 macimorelin 1 clonidine and 1 arginine test done The level of growth hormone GH will be measured 4 times during the clonidine and during the arginine test and 5 times during the macimorelin test After the test questions on the test tolerability will be captured from patients and parents After the arginine test a urine dipstick test is to be done by the patient at home
The study will last for about 1 to 4 months dependent on how close the visits are done At the visits 2 3 4 and 5 the patient will get a stimulation test done and blood samples will be taken At those 4 visits the patient will have either to drink a macimorelin drink take some clonidine tablets or get an arginine infusion In total the patient will get 2 macimorelin 1 clonidine and 1 arginine test done The level of growth hormone GH will be measured 4 times during the clonidine and during the arginine test and 5 times during the macimorelin test After the test questions on the test tolerability will be captured from patients and parents After the arginine test a urine dipstick test is to be done by the patient at home
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1248-5075 | OTHER | Universal Trial Number | None |
| 2018-001989-42 | EUDRACT_NUMBER | None | None |