Growth Hormone Deficiency Clinical Trial
Official title:
A Phase III, Multicentric, Open-label, Randomised, Comparative, Parallel Group Study of (GHRH + Arginine) Combination Test vs. Insulin Tolerance Test (ITT) in the Diagnosis of Adult Growth Hormone Deficiency (AGHD)
The aim of the study is to determine the specificity and sensitivity of the combined growth hormone releasing hormone (GHRH) + Arginine test in healthy volunteers, subjects with highly probable adult growth hormone deficiency (AGHD) and subjects who were probably free of AGHD.
The randomisation was carried out before the first test was performed. In order to be
informed of the subject's randomisation group, the investigator phoned the access number
given to him/her. The subject's allocation to a given randomisation arm was determined on
the basis of a centralised randomisation (answering service), balanced per group of subjects
with a minimisation on 2 criteria: age and BMI.
This was a centralised randomisation using a Interactive Voice Response System (IVRS) which
was balanced in each of the following 3 categories of subjects:
- Category A = healthy volunteers,
- Category B = subjects with a strong probability of deficit in GH,
- Category C = subjects with a low probability of deficit in GH.
In each of these 3 categories, the subjects underwent 3 tests whose sequences were
determined by the following randomisation group:
- Group 1: GHRH+Arg, GHRH+Arg, ITT or
- Group 2: ITT, ITT, GHRH+Arg.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| 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 |
NCT00235599 -
The IGFBP-3 Stimulation Test: A New Tool for the Diagnosis of Growth Hormone Deficiency in Children.
|
N/A | |
| Completed |
NCT00149708 -
Consequence of Lifetime Isolated Growth Hormone Deficiency
|
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 |
NCT01062529 -
Peripheral Metabolic Effects of Somatostatin
|
N/A | |
| Completed |
NCT00965484 -
Genotropin Study Assessing Use of Injection Pen
|
Phase 3 | |
| 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 |
NCT00957671 -
Anterior Pituitary Hormone Replacement in Traumatic Brain Injury
|
Phase 4 |