Clinical trials: Idiopathic Short Stature (ISS)
Idiopathic Short Stature (ISS)
Somatropin + Leuprorelin vs Somatropin Alone in Pubertal Children With Idiopathic Short Stature
The present randomized trial was initially intended to study the benefits of a combined treatment with growth hormone (GH) and a gonadotropin-releasing hormone (GnRH) agonist for pubertal children with idiopathic short stature.
- Trial name
- Phoenix (NCT00355030)
- Testing
- somatropin, leuprorelin
- Where
- 19 sites in France, Netherlands
- Volunteers
- 91 people
- Sponsor
- Eli Lilly and Company
Turner Syndrome, Idiopathic Short Stature
Study to Identify Markers of Insulin Resistance During Growth Hormone Treatment for Short Stature
Growth hormone treatment improves body fat distribution but also causes insulin resistance. Scientists have recently linked insulin resistance with special stores of fat in the muscles, which can be measured by magnetic resonance…
- Trial name
- NCT00121875
- Testing
- somatropin (rDNA)
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Massachusetts General Hospital
Idiopathic Short Stature
A Study to Assess Growth in Children With Idiopathic Short Stature
Study 111-903 will generate baseline growth data in children with ISS by collecting growth measurements and other variables of interest.
- Trial name
- NCT06309979
- Where
- 38 sites in United States
- Volunteers
- 300 people
- Sponsor
- BioMarin Pharmaceutical
Idiopathic Short Stature
Predictive Value of the Insulin-like Growth Factor-1 (IGF-1) Generation Test for the Growth Response to Growth Hormone Treatment (PRED-IGF)
The evaluation of a standardized diagnostic test to predict the growth response in a 1 year trial with Growth Hormone (GH) treatment (carried out in the context of regular patient care) in non GH deficient short children with low…
- Trial name
- NCT01438801
- Testing
- Nutropin [Somatropin (rDNA origin) for injection]
- Sponsor
- Ipsen
Growth Hormone Deficiency, Idiopathic Short Stature
Genotropin Study Assessing Use of Injection Pen
Assessment of Genotropin patient and caregiver (Dyad) perception of convenience and preference of Genotropin injection pen. Patients already on genotropin will be asked to use a genotropin pen for 2 months.
- Trial name
- NCT00965484
- Testing
- New Genotropin Pen
- Where
- 25 sites in United States
- Volunteers
- 136 people
- Sponsor
- Pfizer
ISS- Idiopathic Short Stature
The Effect of Nutritional Formula Supplementation on Linear Growth of Growth Hormone (GH) Treated Prepubertal Children With Idiopathic Short Stature (ISS) After 2 Years From the Beginning of GH-therapy
The proposed study is a double blind, randomized, placebo controlled study. The aim of the study is to evaluate the effect of combined growth hormone (GH) treatment \&nutritional formula supplementation versus GH \& placebo on…
- Trial name
- NCT04962360
- Testing
- Nutritional supplementation standardized formula
- Where
- Israel
- Volunteers
- 64 people
- Sponsor
- Rabin Medical Center
Growth Hormone Deficiency, Attention Deficit Disorder
The Impact of the Use of Recombinant Human Growth Hormone on ADHD Characteristics in Children and Adolescents
Analysis of the short-and long-term impact of recombinant growth hormone on attention deficit and hyperactivity charachteristics in children and adolescents.
- Conditions
- Growth Hormone Deficiency, Attention Deficit Disorder, Idiopathic Short Stature
- Trial name
- NCT02973061
- Testing
- Questionnaires
- Where
- Israel
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Assaf-Harofeh Medical Center
Growth Hormone Disorder, Growth Hormone Deficiency in Children
Safety and Efficacy of Long-term Somatropin Treatment in Children
This study is conducted in Europe. The aim of this study is to evaluate safety during the long-term use of somatropin (Norditropin®) in children as well as efficacy on change in height.
- Conditions
- Growth Hormone Disorder, Growth Hormone Deficiency in Children, Foetal Growth Problem, Small for Gestational Age
- Trial name
- GrowthWIN II (NCT01543867)
- Testing
- somatropin
- Where
- Germany
- Volunteers
- 5,442 people
- Sponsor
- Novo Nordisk A/S
Growth Hormone Disorder, Growth Hormone Deficiency in Children
Effect of Growth Hormone in Children With Growth Hormone Deficiency
This trial is conducted in the United States of America (USA). The purpose of the trial is to compare the effect of Norditropin® using different dosing regimens in children suspected of growth hormone deficiency.
- Conditions
- Growth Hormone Disorder, Growth Hormone Deficiency in Children, Growth Disorder, Idiopathic Short Stature
- Trial name
- NCT00262249
- Testing
- somatropin
- Where
- 40 sites in United States
- Volunteers
- 173 people
- Sponsor
- Novo Nordisk A/S
Idiopathic Short Stature
A 4 Year Combination Therapy of Growth Hormone and (GnRH) Agonist in Children With a Short Predicted Height
Estrogens are responsible for the disappearance of growth cartilage in the long bones at the end of the pubertal growth spurt both in boys and in girls.
- Trial name
- ZomaTrip (NCT00840944)
- Testing
- somatropin, triptorelin
- Where
- 6 sites in Belgium
- Volunteers
- 44 people
- Sponsor
- Belgian Study Group for Pediatric Endocrinology
Idiopathic Short Stature
Multidisciplinary Evaluation and a Genome-wide Analysis in a Cohort of Idiopathic Short Stature Patients
This trial aims to evaluate the prevalence of idiopathic short stature among children whose growth is above -2,5SD (AFPA- CRESS/Inserm -CompuGroup Medical 2018 curve) or above -2SD of the parental target size (taking child gender…
- Trial name
- PAG PETI (NCT05858606)
- Testing
- Evaluation of the prevalence of truly (authentified) idiopathic short stature after multidisciplinary clinico-radiological evaluation, analysis in a multidisciplinary consultation meeting via a secure platform (ShareConfrère) for evaluation by multidisciplinary team, Whole genome analysis for authentified idiopathic short stature
- Where
- France
- Volunteers
- 200 people
- Sponsor
- University Hospital, Montpellier
Dwarfism
Efficacy and Safety of rhGH (Jintropin®) in Pediatric Participants With ISS
Phase 1: To evaluate the safety and efficacy of 0.05mg/kg/d of rhGH (Jintropin®) in the treatment of children with idiopathic short stature (ISS) in 52 weeks.
- Trial name
- NCT03635580
- Testing
- Negative control
- Where
- 9 sites in China
- Volunteers
- 480 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Idiopathic Short Stature
A Study (Phase 1b/2) of GenSci134 in Children With Idiopathic Short Stature (ISS)
This study comprises two phases: Phase Ib and Phase II. Phase Ib is a multicenter, randomized, open-label, active-controlled, single-dose, dose-escalation study to evaluate the safety, tolerability, PK/PD profile, and…
- Trial name
- NCT07450053
- Testing
- GenSci134 Injection, Recombinant Human Growth Hormone Injection(Norditropin® FlexPro®)
- Where
- China
- Volunteers
- 128 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Establishing Dose of Sr-hGH in ISS Patients
Efficacy and Safety Study of Sr-hGH in Comparison With Daily hGH in ISS Patients
The purpose of this study is to assess dosing requirements and establish the efficacy of SR-hGH in idiopathic short stature patients (ISS).
- Trial name
- NCT02042170
- Testing
- human growth hormone self-injection
- Where
- South Korea
- Volunteers
- 46 people
- Sponsor
- LG Life Sciences
Growth Hormone Deficiency
Safety Study of Syntropin (Human Growth Hormone) for the Treatment of Growth Hormone Deficiency
The purpose of this study is to evaluate the pharmacokinetics of Syntropin (a human growth hormone) and to determine the serum concentration of IGF-1 after Syntropin injection.
- Trial name
- NCT00489294
- Testing
- Syntropin
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Phage Pharmaceuticals, Inc.
Idiopathic Short Stature
The Efficacy and Safety of Inpegsomatropin Injection in Children With Idiopathic Short Stature
This is a multicenter, randomized, open-label, active-controlled Phase III clinical trial to evaluate the efficacy and safety of Inpegsomatropin injection，once a week，compared with recombinant human growth hormone (rhGH) in…
- Trial name
- NCT06927310
- Testing
- Inpegsomatropin Injection, Recombinant Human Growth Hormone Injection
- Where
- 38 sites in China
- Volunteers
- 300 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Idiopathic Short Stature
Growth Response in Short Children Suffering From a Disease With Growth Retardation and Treated With Somatropin
Growth hormone therapy will improve the height of short statured children with pathological conditions that lead to growth retardation.
- Trial name
- ISS (NCT00488124)
- Testing
- somatropin (Genotropin® treatment)
- Where
- 13 sites in Germany
- Volunteers
- 120 people
- Sponsor
- University of Erlangen-Nürnberg Medical School
ISS, SGA
Comparison of Weekly Somatrogon to Daily Genotropin in Children Born Small for Gestational Age or With Idiopathic Short Stature.
This study is a randomized, open-label, active controlled, parallel group study comparing the efficacy and safety of once weekly Somatrogon to daily Growth Hormone (Genotropin) in pre-pubertal children with short stature either…
- Trial name
- MISSION (NCT07226089)
- Testing
- Somatrogon, Genotropin
- Where
- 32 sites in United States, France and 3 more
- Volunteers
- 254 people
- Sponsor
- Rabin Medical Center
Idiopathic Short Stature
A Study of the Genetic Basis of Response to Growth Hormone Treatment in Children With Idiopathic Short Stature
The study doctor will collect information from participants with Idiopathic Short Stature, who were treated with growth hormone for at least a year when they were children, before they reached puberty.
- Trial name
- NCT05894876
- Testing
- No treatment is given
- Where
- 4 sites in United States, Brazil and 1 more
- Volunteers
- 43 people
- Sponsor
- Novo Nordisk A/S
Dwarfism
A Study Extension Period of PEG-somatropin (Pegylated-somatropin) in the Treatment of Children With Idiopathic Short Stature
After the first stage (52 weeks) of Phase II clinical trial, Pegylated recombinant human growth hormone (PEG-rhGH) injection of appropriate dose in compliance with ISS clinical treatment strategy is used to treat children with…
- Trial name
- NCT03255694
- Testing
- PEG-somatropin
- Where
- 12 sites in China
- Volunteers
- 360 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.