Clinical trials: Growth Hormone Treatment
Growth Disorder, Idiopathic Short Stature
Efficacy and Safety of Recombinant Human Growth Hormone on Height Velocity in Subjects With Idiopathic Short Stature
This trial is conducted in Asia. The aim of this trial is to evaluate the efficacy and safety of recombinant human growth hormone (hGH) in subjects with idiopathic short stature in Korea.
- Trial name
- NCT01778023
- Testing
- somatropin
- Where
- 8 sites in South Korea
- Volunteers
- 54 people
- Sponsor
- Novo Nordisk A/S
Osteogenesis Imperfecta
Pamidronate to Treat Osteogenesis Imperfecta in Children
This study will evaluate the effect of pamidronate a drug that decreases bone resorption (breakdown) on osteogenesis imperfecta. This is a genetic disorder of collagen, the major protein in bone.
- Trial name
- NCT00005901
- Testing
- Pamidronate (Aredia)
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Turner Syndrome
Somatropin Treatment to Final Height in Turner Syndrome
A randomized, controlled trial in girls with Turner syndrome at least 7 years old and younger than 13 at study entry, to determine the efficacy and safety of Humatrope (somatropin) treatment in promoting linear growth to final…
- Trial name
- GDCT (NCT00191113)
- Testing
- Somatropin, Ethinyl estradiol, Medroxyprogesterone acetate
- Where
- 14 sites in Canada
- Volunteers
- 154 people
- Sponsor
- Eli Lilly and Company
Crohn's Disease
Trial of Growth Hormone Therapy in Pediatric Crohn's Disease
The purpose of this study is to determine whether taking a growth hormone (GH) drug called somatropin causes the intestine of a person with Crohn's Disease (CD) to heal faster when compared to a person with Crohn's Disease that…
- Trial name
- NCT00109473
- Testing
- growth hormone, cortecosteroid
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Growth Hormone Therapy, Infant, Small for Gestational Age
Neuromuscular Changes In Small For Gestational Age Children During Somatropin Therapy
The planned study focuses on the effect of a one year Somatropin treatment (0.035 mg/kg/d or 0.067 mg/kg/d) in short children born SGA on neuromuscular function and cognitive performance.
- Trial name
- SGA-POWER (NCT00625872)
- Testing
- Somatropin
- Where
- 10 sites in Germany
- Volunteers
- 23 people
- Sponsor
- Pfizer
Idiopathic Growth Hormone Deficiency, Turner Syndrome
First Year Growth Response Associated Genetic Markers Validation Phase IV Open-label Study in Growth Hormone Deficient and Turner Syndrome Pre-pubertal Children: the PREDICT Pharmacogenetics Validation Study
PREDICT Validation is a validation pharmacogenetic trial. The purpose of this study is to confirm that some genes can be used to predict how well a subject diagnosed with idiopathic growth hormone deficiency (IGHD) or turner…
- Trial name
- NCT01419249
- Testing
- Blood sampling
- Where
- 31 sites in Argentina, Canada and 7 more
- Volunteers
- 458 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Growth Hormone Deficiency
Comparison of a Needle-free Injection Method With a Needle-syringe Injection Method
The purpose of this study is to obtain psychological response and user preference information on the use of the T jet® device versus the traditional subcutaneous injection administration of Tev Tropin®.
- Trial name
- T-jet® (NCT00990340)
- Testing
- T-jet® containing TevTropin®, TevTropin® needle-syringe injection method
- Volunteers
- 52 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Breast Cancer
A Study of HR+/HER2- Metastatic Breast Cancer Patients Treated With Palbociclib Together With an Aromatase Inhibitor From 2017 to 2023 in Denmark.
The purpose of this study is to describe the effect of the medicine palbociclib when given together with an aromatase inhibitor for treatment of breast cancer.
- Trial name
- NCT06307457
- Testing
- Palbociclib in combination with AI
- Where
- Denmark
- Volunteers
- 604 people
- Sponsor
- Pfizer
Growth Hormone Deficiency in Children
A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day (REAL4)
The study compares 2 medicines for children who do not have enough hormone to grow: somapacitan given once a week (a new medicine) and Norditropin® given once a day (the medicine doctors can already prescribe).
- Trial name
- REAL4 (NCT03811535)
- Testing
- Somapacitan, Norditropin®
- Where
- 139 sites in United States, Algeria and 24 more
- Volunteers
- 200 people
- Sponsor
- Novo Nordisk A/S
Short Stature
Growth Hormone Treatment in Patients With Aggrecan (ACAN) Deficiency
This is an open-label, single-arm prospective pilot study to study the effects of a single dose regimen of daily growth hormone medication (Norditropin) on pre-pubertal children with Aggrecan deficiency.
- Trial name
- NCT03288103
- Testing
- Norditropin
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Phelan McDermid Syndrome
Growth Hormone Treatment in Children With Phelan McDermid Syndrome
Phelan McDermid syndrome (PMS) is a rare genetic form of autism spectrum disorder (ASD) due to deletions or mutations in the SHANK3 gene.
- Trial name
- NCT04003207
- Testing
- Recombinant human Growth hormone
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Swathi Sethuram
Endocrine System Diseases
Treatment With Recombinant Human Growth Hormone (GH) in Children With Short Stature Secondary to a Long Term Corticoid Therapy
To assess the effect of a long-term treatment by Genotonorm on linear growth in children with short stature receiving steroid therapy To assess the effect of a long term treatment with Genotonorm on bone mineralisation To assess…
- Trial name
- NCT00174187
- Testing
- Somatropin
- Where
- 2 sites in France
- Volunteers
- 30 people
- Sponsor
- Pfizer
Growth Disorders, Intrauterine Growth Retardation
Genotropin Treatment in Short Prepubertal Children With Intra-Uterine Growth Retardation
To evaluate the effect of continuous and intermittent administration of Genotonorm on stature in short prepubertal children with intra-uterine growth retardation
- Trial name
- NCT01073605
- Testing
- Genotonorm
- Where
- 31 sites in France
- Volunteers
- 208 people
- Sponsor
- Pfizer
Growth Hormone Deficiency, Turner Syndrome
Predictive Markers in Growth Hormone Deficiency (GHD) and Turner Syndrome (TS) Children Treated With SAIZEN®
The study aims at identifying the predictive markers after one month of Saizen therapy in Growth Hormone Deficiency (GHD) and Turner Syndrome children.
- Trial name
- NCT00256126
- Testing
- Saizen
- Where
- 13 sites in Argentina, Australia and 11 more
- Volunteers
- 318 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Idiopathic Short Stature
A Phase 3 Study to Evaluate the Safety and Efficacy of Saizen® in Children With Idiopathic Short Stature (ISS)
This is an open-label, multi-center, randomized, two-arm parallel, no-treatment group controlled (only for the first 6 months), Phase 3 study in children with ISS.
- Trial name
- NCT01746862
- Testing
- Saizen®
- Where
- South Korea
- Volunteers
- 90 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Growth Hormone Deficiency
Safety and Efficacy Study of MOD-4023 to Treat Children With Growth Hormone Deficiency
Treatment of children with growth failure due to growth hormone deficiency (GHD). Primary • To evaluate the efficacy and safety of weekly MOD-4023 administration compared to daily Genotropin® administration in Japanese…
- Trial name
- NCT03874013
- Testing
- MOD-4023, Genotropin
- Where
- 46 sites in Japan
- Volunteers
- 44 people
- Sponsor
- OPKO Health, Inc.
Growth Hormone Disorder, Growth Hormone Deficiency in Children
Investigating Efficacy and Safety of Once-weekly NNC0195-0092 Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency
This trial is conducted globally. The aim of the trial is to investigate efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment…
- Trial name
- NCT02616562
- Testing
- somapacitan, Norditropin® FlexPro® pen
- Where
- 89 sites in United States, Austria and 12 more
- Volunteers
- 76 people
- Sponsor
- Novo Nordisk A/S
Idiopathic Short Stature
Individualized, Target-Driven Treatment Of Children With Idiopathic Short Stature
To demonstrate that an individualized, formula-based Genotropin regimen for children with Idiopathic Short Stature will lead to a targeted height gain (to reach the target of 10th percentile (%), or -1.3 SDS) during 24 months of…
- Trial name
- NCT00396097
- Testing
- Genotropin
- Where
- 43 sites in United States
- Volunteers
- 316 people
- Sponsor
- Pfizer
Children Born With Serious Intra-uterine Growth Retardation
Saizen in Intra-uterine Growth Retardation
Study of safety of Saizen® in children born with serious intra-uterine growth retardation (IUGR) treated to final height. An open, phase III study involving 17 centers in France.
- Trial name
- NCT01400698
- Testing
- Saizen® A, Saizen® B, Observation only
- Volunteers
- 91 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Small Gestational Age (SGA)
Optimization of the Dosage Regimen of Growth Hormone Therapy in Children Born Small for Gestational Age
Multicentric, open-label, randomized, pilot comparative study in parallel groups comparing 1 group of subjects receiving 0.057 milligram/kilogram/day (mg/kg/day) or 0.40 mg/kg/week of Saizen® during 1 year to 1 group receiving…
- Trial name
- SGA OPTIMIS (NCT00249821)
- Testing
- Saizen®
- Volunteers
- 22 people
- Sponsor
- Merck KGaA, Darmstadt, Germany