Clinical Trials Logo

Clinical Trial 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).


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04786873
Study type Interventional
Source AEterna Zentaris
Contact
Status Active, not recruiting
Phase Phase 3
Start date November 16, 2021
Completion date June 2024

See also
  Status Clinical Trial Phase
Recruiting NCT02243852 - Effects of Growth Hormone (GH) Deficiency and Growth Hormone Replacement on Serum Fibroblast Growth Factor 21 (FGF21) N/A
Completed NCT01440686 - Safety, Pharmacokinetics and Pharmacodynamics Study of HL-032 in Healthy Male Volunteers Phase 1
Completed NCT00990340 - Comparison of a Needle-free Injection Method With a Needle-syringe Injection Method Phase 4
Completed NCT00149708 - Consequence of Lifetime Isolated Growth Hormone Deficiency N/A
Completed NCT00235599 - The IGFBP-3 Stimulation Test: A New Tool for the Diagnosis of Growth Hormone Deficiency in Children. N/A
Completed NCT00459940 - The Effects of TZD on Fat Metabolism and Insulin Sensitivity in GH-Replaced GHD Patients N/A
Completed NCT01157793 - A Multicentre, Randomised, Open-label, Controlled Study to Evaluate the Effects of Saizen® on Cardiac Function in Growth Hormone Deficient(GHD) Subjects During the Transition Phase From Childhood to Adulthood Phase 4
Completed NCT00004365 - Study of Pituitary Size and Function in Familial Dwarfism of Sindh N/A
Recruiting NCT00227253 - Chromosome 18 Clinical Research Center
Recruiting NCT04121780 - Growth Hormone Replacement Therapy for Retried Professional Football Players Phase 2
Completed NCT02934399 - Dynamic Hormone Diagnostics in Endocrine Disease
Completed NCT01090778 - Diurnal Variation of Exogenous Peptides (GH Puls/Jurgita I) Phase 2
Completed NCT00965484 - Genotropin Study Assessing Use of Injection Pen Phase 3
Completed NCT01062529 - Peripheral Metabolic Effects of Somatostatin N/A
Completed NCT00616278 - National Cooperative Growth Study in CKD N/A
Completed NCT02693522 - Evaluation of Efficacy and Safety of Recombinant Somatroipn in Patients With Growth Hormone Deficiency Phase 3
Recruiting NCT02908958 - Clinical Study of Pegylated Somatropin to Treat Children Growth Hormone Deficiency Phase 4
Terminated NCT01243892 - A Study to Evaluate Growth in Participants Treated With Somatropin (Nutropin) Using NuSpin Device N/A
Withdrawn NCT00638287 - Inter-Assay Growth Hormone and IGF-I Variability N/A
Completed NCT00929799 - Growth Hormone and Glucose Metabolism Phase 4