Phase 3 N=316 Individualized, Target-Driven Treatment Of Children With Idiopathic Short Stature
Idiopathic Short Stature
Primary: Absolute On-target Difference (AOTD) at 24 Months — 0.603; 0.625 Standard Deviation Score (SDS) — p=0.5762
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 3 N=136 Prepubertal Children With Growth Failure Associated With Primary Insulin-Like Growth Factor-1 (IGF-1) Deficiency
Growth Disorders · Insulin-Like Growth Factor-1 Deficiency
Primary: Height Velocity During the First Year - Intent to Treat (ITT)Population — 5.2; 6.9; 7.7 cm/yr — p=<0.0001
Phase 3 N=70 Efficacy and Safety of DA-3002 in Children With Idiopathic Short Stature
Idiopathic Short Stature
Primary: Annualized Height Velocity(cm/Year) After 26 Weeks — 10.68; 5.72 cm/year
Phase 3 N=45 Recombinant Human Insulin-Like Growth Factor (rhIGF-1) Treatment of Short Stature Associated With IGF-1 Deficiency
Insulin-Like Growth Factor-1 Deficiency · Growth Disorders
Primary: Height Velocity From Pretreatment (Week 0) to Week 34 — 7.0 centimeters per year (cm/yr)
Phase 3 N=54 Efficacy and Safety of Recombinant Human Growth Hormone on Height Velocity in Subjects With Idiopathic Short Stature
Growth Disorder · Idiopathic Short Stature
Primary: Height Velocity (Ht-V) — 12.02; 6.87 cm/year — p=<0.0001
Phase 3 N=42 Growth Hormone Therapy in Osteogenesis Imperfecta
Osteogenesis Imperfecta
Primary: Proportion of Subjects Who Met Criteria of Increase in Growth Rate Since Baseline. — 25 Participants
Phase 3 N=76 Aromatase Inhibitors, Alone And In Combination With Growth Hormone In Adolescent Boys With Idiopathic Short Stature
Idiopathic Short Stature
Primary: Change in Height — 14; 17.1; 18.9 Centimeters — p=<0.006
Phase 3 N=208 Genotropin Treatment in Short Prepubertal Children With Intra-Uterine Growth Retardation
Growth Disorders · Intrauterine Growth Retardation
Primary: Change From Baseline in Annual Growth Rate Measured at 2 Years Following Treatment With Genotonorm — 3.07; 3.97; 2.84 cm/year — p=0.02922
Phase 3 N=90 A Phase 3 Study to Evaluate the Safety and Efficacy of Saizen® in Children With Idiopathic Short Stature (ISS)
Idiopathic Short Stature
Primary: Change From Baseline in Height Velocity at Month 6 Using Last Observation Carried Forward (LOCF) Method — 5.63; 4.94; 4.45; 1.01 centimeter/year (cm/yr) — p=<0.0001
Phase 3 N=46 Growth Retardation In Children With Special Pathological Conditions Or Disease
Endocrine System Diseases
Primary: Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36 in Intent-to-Treat (ITT) Population — -1.29; 2.36 SDS
Phase 2 N=7 IGF-1 Treatment for Individuals With Short Stature Due to PAPP-A2 Deficiency
Short Stature
Primary: Height Velocity — 3.0; 4.3; 6.2; 4.8 cm/y
Phase 3 N=91 Saizen in Intra-uterine Growth Retardation
Children Born With Serious Intra-uterine Growth Retardation
Primary: Final Height — 145.90; 150.06; 153.27; 155.59 cm
Phase 3 N=91 Somatropin + Leuprorelin vs Somatropin Alone in Pubertal Children With Idiopathic Short Stature
Idiopathic Short Stature (ISS)
Primary: Number of Participants With One or More Drug-related Adverse Events — 42; 38; 11; 9 participants
Phase 3 N=92 Long-Term Treatment With rhIGF-1 in GHIS
Growth Hormone Insensitivity Syndrome
Primary: Annualized Height Velocity Up to 12 Years — 2.6; 8.0; 5.9; 5.5 centimeter per year (cm/y)
Phase 2 N=33 Somatropin Therapy In Children Born Preterm But Appropriate For Gestational Age
Growth Hormone Therapy · Infant, Very Low Birth Weight
Primary: Change in Height Standard Deviation Score (SDS) After 1 Year — 1.099; 0.108 centimeters — p=<0.001
Phase 2 N=6 Growth Hormone Treatment in Children With Phelan McDermid Syndrome
Phelan McDermid Syndrome
Primary: ABC - Social Withdrawal Subscale — 10.31; 4.6; 14.8; 6.2 score on a scale
Phase 3 N=98 Growth Hormone Treatment in Children Born Small for Gestational Age (SGA)
Foetal Growth Problem · Small for Gestational Age
Primary: Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 260 - Subjects Received NN220 Treatment for 5 Years — -2.9488; -2.9047; 1.2066; 2.0247…
Phase 2 N=16 Safety Profile of Insulin Like Growth Factor-1 (IGF-I) Administration in Adolescents
Anorexia Nervosa
Primary: Change in Levels of Insulin Like Growth Factor-1 (IGF-I) Following Recombinant Human (rh) IGF-1 Administration in Girls With Anorexia Nervosa — 542.9 ng/ml — p=<0.05
Phase 3 N=43 Genotropin Treatment In Very Young Children Born Small For Gestational Age
Infant, Small for Gestational Age
Primary: Change From Baseline in Height Standard Deviation Score (SDS) at Month 24. — 1.63; 0.43 SDS — p=<0.001
Phase 2 N=19 Clinical Trial in 22q13 Deletion Syndrome(Phelan-McDermid Syndrome)
22q13 Deletion Syndrome · Phelan-McDermid Syndrome
Primary: Change in Aberrant Behavior Checklist - Social Withdrawal (ABC-SW) Subscale - Study 1 — 15.78; 11.22; 7.61; 9.70 score on a scale
N/A N=52 Ghrelin Levels in Children With Poor Growth
Idiopathic Short Stature · Failure to Thrive
Primary: Total Ghrelin Level — 1063; 1264; 1157 pg/mL
Phase 3 N=57 Study Aimed At Improving Height With Genotonorm In Children Born Little And/Or Light With Growth Retardation At The Age
Fetal Growth Retardation
Primary: Percentage of Children With Insulin Growth Factor-1 (IGF-1) > 2 Standard Deviation (SD) at 9 and 12 Months — 86.0; 14.0 percentage of participants
Phase 4 N=61 Long Term Study of Genotropin (Somatropin) for Short Children Born Small for Gestational Age (SGA)
Short Stature Born Small for Gestational Age (SGA)
Primary: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) — 27; 31; 10; 5 participant
N/A N=22,845 Observational Study of Somatropin Treatment in Children
Growth Hormone (GH) Deficiency · Short Stature Homeobox Containing Gene (SHOX) Deficiency · SHOX Deficiency-related Disorder
Primary: Type 2 Diabetes Mellitus in GH-treated Participants — 1; 9; 8 Incident Cases
Phase 4 N=278 Safety and Efficacy of Omnitrope® (rhGH) in Short Children Born Small for Gestational Age (SGA)
Small for Gestational Age
Primary: Number of Participants With Development of Diabetes in Short Children Born SGA During Treatment — 0 Participants
Phase 4 N=69 Long-Term Growth and Skeletal Effects of Early Growth Hormone Treatment in Turner Syndrome
Turner Syndrome
Primary: Most Mature Height Standard Deviation Score (SDS) — -1.37; -1.60 standard deviation score
Phase 4 N=66 Long-term Evaluation on Height and Weight in Patients With MPS II Who Started Treatment at < 6 Years of Age
Hunter Syndrome
Primary: Height Overall — 113.759; 108.143 centimeter (cm) — p== 0.011
Phase 4 N=17 A Study to Optimize Growth Hormone Dosing in Children With Chronic Kidney Disease by Measuring IGF-1 Levels in Blood
Kidney Failure, Chronic · Growth Hormone Deficiency
Primary: The Change in Amount of Insulin Like Growth Factor (IGF-I) Generated (Day 8-day 1) — 115; 129 mcg/L
Phase 3 N=51 Investigating the Long-term Efficacy and Safety of Two Doses of NN-220 (Somatropin) in Short Stature Due to Noonan Syndrome
Genetic Disorder · Noonan Syndrome
Primary: Change in Height SDS (Japanese National Reference Data) — 0.84; 1.47 Standard deviation score — p=< 0.0001
Phase 4 N=115 Growth Hormone Treatment for the Prevention of Short Stature in Young Girls With Turner Syndrome Before the Age of 4 Years
Turner's Syndrome
Primary: Height SDS at Year 4 — -1.35; -2.44 standard deviation score