195. ヌーナン症候群 Noonan syndrome Clinical trials / Disease details


臨床試験数 : 25 薬物数 : 23 - (DrugBank : 5) / 標的遺伝子数 : 2 - 標的パスウェイ数 : 9

  
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05723835
(ClinicalTrials.gov)
February 1, 202329/1/2023A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9A Study Evaluating the Safety and Efficacy of Once-weekly Dosing of Somapacitan in a Basket Study Design in Paediatric Participants With Short Stature Either Born Small for Gestational Age or With Turner Syndrome, Noonan Syndrome or Idiopathic Short StatureSGA;Turner Syndrome;Noonan Syndrome;ISSDrug: SomapacitanNovo Nordisk A/SNULLRecruiting10 Years18 YearsAll48Phase 3United States;Korea, Republic of;Malaysia;Netherlands;Poland;Spain
2EUCTR2021-005607-13-NL
(EUCTR)
06/12/202202/06/2022A research study to compare somapacitan once a week with Norditropin® once a day in children who need help to growA study comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® as well as evaluating long-term safety of somapacitan in a basket study design inchildren with short stature either born small for gestational age or with Turner syndrome,Noonan syndrome, or idiopathic short stature. Short stature born small for gestational age Turner syndromeNoonan syndromeIdiopathic short stature
MedDRA version: 20.0;Level: PT;Classification code 10045181;Term: Turner's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10029748;Term: Noonan syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 23.0;Level: LLT;Classification code 10066333;Term: Idiopathic short stature;System Organ Class: 100000004859
MedDRA version: 21.1;Classification code 10041093;Term: Small for gestational age;System Organ Class: 100000004868;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Sogroya 10 mg/1.5 mL solution for injection in pre-filled pen
INN or Proposed INN: Somapacitan
Other descriptive name: Somapacitan
Product Name: somapacitan 5 mg/1.5 mL PDS290
INN or Proposed INN: Somapacitan
Other descriptive name: Somapacitan
Product Name: Somapacitan 15 mg/1.5 mL PDS290
INN or Proposed INN: Somapacitan
Other descriptive name: Somapacitan
Trade Name: Norditropin FlexPro 10 mg/1.5 ml, solution for injection in pre-filled pen
INN or Proposed INN: Somatropin
Other descriptive name: Somatropin
Novo Nordisk A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
395Phase 3United States;Serbia;Saudi Arabia;Greece;Spain;Thailand;Ireland;Israel;Russian Federation;Switzerland;India;Malaysia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Austria;United Kingdom;Mexico;European Union;Canada;Poland;Brazil;Belgium;Croatia;Bulgaria;Germany;Japan
3EUCTR2021-005607-13-DE
(EUCTR)
10/10/202212/05/2022A research study to compare somapacitan once a week with Norditropin® once a day in children who need help to growA study comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® as well as evaluating long-term safety of somapacitan in a basket study design inchildren with short stature either born small for gestational age or with Turner syndrome,Noonan syndrome, or idiopathic short stature. Short stature born small for gestational age Turner syndromeNoonan syndromeIdiopathic short stature
MedDRA version: 20.0;Level: PT;Classification code 10045181;Term: Turner's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10029748;Term: Noonan syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 23.0;Level: LLT;Classification code 10066333;Term: Idiopathic short stature;System Organ Class: 100000004859
MedDRA version: 21.1;Classification code 10041093;Term: Small for gestational age;System Organ Class: 100000004868;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Sogroya 10 mg/1.5 mL solution for injection in pre-filled pen
INN or Proposed INN: Somapacitan
Other descriptive name: Somapacitan
Product Name: somapacitan 5 mg/1.5 mL PDS290
INN or Proposed INN: Somapacitan
Other descriptive name: Somapacitan
Product Name: Somapacitan 15 mg/1.5 mL PDS290
INN or Proposed INN: Somapacitan
Other descriptive name: Somapacitan
Trade Name: Norditropin FlexPro 10 mg/1.5 ml, solution for injection in pre-filled pen
INN or Proposed INN: Somatropin
Other descriptive name: Somatropin
Novo Nordisk A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
395Phase 3United States;Serbia;Saudi Arabia;Greece;Spain;Thailand;Ireland;Israel;Russian Federation;Switzerland;India;Malaysia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Austria;United Kingdom;Mexico;European Union;Canada;Poland;Brazil;Belgium;Croatia;Bulgaria;Germany;Japan
4JPRN-jRCT2031220263
10/08/202210/08/2022A study comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin as well as evaluating long-term safety of somapacitan in a basket study design in children with short stature either born small for gestational age or with Turner syndrome, Noonan syndrome, or idiopathic short statureA study comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin as well as evaluating long-term safety of somapacitan in a basket study design in children with short stature either born small for gestational age or with Turner syndrome, Noonan syndrome, or idiopathic short stature (NN8640-4467) - REAL8 SGA, Turner syndrome, Noonan syndrome or idiopathic short stature (ISS)0.24mg/kg/week s.c. treatment of somapacitan or 0.035mg/kg/day, 0.05mg/kg/day, 0.067mg/kg/day s.c. growth hormone (GH) (Norditropin) treatmentSuzuki TaikiNULLRecruiting>= 2age 6month old< 11age oldBoth45Phase 3Austria;Belgium;Brazil;Bulgaria;Canada;China;Croatia;Finland;France;Germany;Greece;India;Ireland;Israel;Italy;Latvia;Lithuania;Malaysia;Mexico;Netherlands;Poland;Portugal;Russia;Saudi Arabia;Serbia;Slovenia;South Africa;South Korea;Spain;Switzerland;Japan
5NCT05330325
(ClinicalTrials.gov)
August 10, 20228/4/2022A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to GrowA Study Comparing the Effect and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® as Well as Evaluating Long-term Safety of Somapacitan in a Basket Study Design in Children With Short Stature Either Born Small for Gestational Age or With Turner Syndrome, Noonan Syndrome, or Idiopathic Short StatureSGA, Turner Syndrome, Noonan Syndrome, ISSDrug: Somapacitan;Drug: Norditropin®Novo Nordisk A/SNULLRecruiting2 Years10 YearsAll399Phase 3United States;Austria;Belgium;Brazil;Bulgaria;Canada;China;Croatia;Finland;France;Germany;Greece;India;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;Poland;Portugal;Saudi Arabia;Serbia;Slovenia;South Africa;Spain;Switzerland;Thailand;United Kingdom
6EUCTR2021-005607-13-SI
(EUCTR)
20/06/202229/04/2022A research study to compare somapacitan once a week with Norditropin® once a day in children who need help to growA study comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® as well as evaluating long-term safety of somapacitan in a basket study design inchildren with short stature either born small for gestational age or with Turner syndrome,Noonan syndrome, or idiopathic short stature. Short stature born small for gestational age Turner syndromeNoonan syndromeIdiopathic short stature
MedDRA version: 20.0;Level: PT;Classification code 10045181;Term: Turner's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10029748;Term: Noonan syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 23.0;Level: LLT;Classification code 10066333;Term: Idiopathic short stature;System Organ Class: 100000004859
MedDRA version: 21.1;Classification code 10041093;Term: Small for gestational age;System Organ Class: 100000004868;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Sogroya 10 mg/1.5 mL solution for injection in pre-filled pen
INN or Proposed INN: Somapacitan
Other descriptive name: Somapacitan
Product Name: somapacitan 5 mg/1.5 mL PDS290
INN or Proposed INN: Somapacitan
Other descriptive name: Somapacitan
Product Name: Somapacitan 15 mg/1.5 mL PDS290
INN or Proposed INN: Somapacitan
Other descriptive name: Somapacitan
Trade Name: Norditropin FlexPro 10 mg/1.5 ml, solution for injection in pre-filled pen
INN or Proposed INN: Somatropin
Other descriptive name: Somatropin
Novo Nordisk A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
395Phase 3Serbia;United States;Saudi Arabia;Greece;Spain;Thailand;Ireland;Russian Federation;Israel;Switzerland;India;Malaysia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Austria;United Kingdom;Mexico;European Union;Canada;Poland;Brazil;Belgium;Croatia;Bulgaria;Germany;Japan
7NCT05308927
(ClinicalTrials.gov)
March 16, 202214/3/2022French Registry of Children Treated With Norditropin® for Short Stature Associated With Noonan SyndromeFrench Registry of Children Treated With Norditropin® for Short Stature Associated With Noonan SyndromeNoonan SyndromeDrug: NorditropinNovo Nordisk A/SNULLEnrolling by invitationN/AN/AAll221France
8NCT05202210
(ClinicalTrials.gov)
January 26, 20227/1/2022Constitution of a Biological Collection to Study the Pathophysiology in Noonan SyndromeConstitution of a Biological Collection to Study the Pathophysiology in Noonan Syndrome and to Identify Predictive Factors of Disease ProgressionNoonan SyndromeBiological: blood and urine samplingUniversity Hospital, ToulouseNULLRecruiting18 Years99 YearsAll100France
9NCT03435627
(ClinicalTrials.gov)
February 26, 201831/1/2018Post Marketing Surveillance on Long-term Use With Norditropin® (Short Stature Due to Noonan Syndrome)Post Marketing Surveillance on Long-term Use With Norditropin® (Short Stature Due to Noonan Syndrome)Genetic Disorder;Noonan SyndromeDrug: SomatropinNovo Nordisk A/SNULLCompleted3 YearsN/AAll71Japan
10EUCTR2016-005022-10-DE
(EUCTR)
13/02/201809/11/2017Improvement of synaptic plasticity and cognitive function in RAS pathway disordersImprovement of synaptic plasticity and cognitive function in RAS pathway disorders Noonan Syndrom and Neurofibromatosis Type 1
MedDRA version: 20.0;Level: PT;Classification code 10029748;Term: Noonan syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10029268;Term: Neurofibromatosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify
Product Name: Lovastatin
INN or Proposed INN: Lovastatin
Other descriptive name: LOVASTATIN
Product Name: Lamotrigin beta
INN or Proposed INN: Lamotrigin
Technische Universität München, Fakultät für MedizinNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 2Germany
11NCT02713945
(ClinicalTrials.gov)
January 25, 20179/3/2016Treatment With HMG-COA Reductase Inhibitor of Growth and Bone Abnormalities in Children With Noonan SyndromeTreatment With HMG-COA Reductase Inhibitor (Simvastatin) of Growth and Bone Abnormalities in Children With Noonan Syndrome: A Phase III Randomised, Double Blind, Placebo-controlled Therapeutic TrialNoonan SyndromeDrug: Simvastatin;Drug: PlaceboUniversity Hospital, ToulouseNULLCompleted6 Years16 YearsAll53Phase 3France
12EUCTR2016-000647-14-FR
(EUCTR)
23/05/201630/03/2016Treatment with simvastatin of growth and bone abnormalities in children with Noonan syndromeTreatment with HMG-COA reductase inhibitor (simvastatin) of growth and bone abnormalities in children with Noonan syndrome : a phase III randomised, double-blind, placebo-controlled therapeutic trial - RASTAT Noonan syndrome;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]Trade Name: Simvastatin
Product Name: Simvastatin
University Hospital ToulouseNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
62Phase 3France
13NCT01927861
(ClinicalTrials.gov)
August 19, 201320/8/2013Investigating the Long-term Efficacy and Safety of Two Doses of NN-220 (Somatropin) in Short Stature Due to Noonan SyndromeA 52-week, Multi-centre, Randomised, Double-blind, Parallel-group, no Treatment Controlled (Open-label) Trial Investigating the Efficacy and Safety of Two Doses of NN-220 in Short Stature With Noonan SyndromeGenetic Disorder;Noonan SyndromeDrug: somatropinNovo Nordisk A/SNULLCompleted3 Years10 YearsAll51Phase 3Japan
14NCT01556568
(ClinicalTrials.gov)
February 201215/3/2012Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MEK162 in Noonan Syndrome Hypertrophic CardiomyopathyAn Open Label Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MEK162 in Noonan Syndrome Hypertrophic CardiomyopathyCardiomegalyDrug: MEK162Array Biopharma, now a wholly owned subsidiary of PfizerNULLWithdrawn18 Years65 YearsAll0Phase 2United States;United Kingdom
15EUCTR2011-003392-10-GB
(EUCTR)
23/01/201224/08/2011A study to look at the effect of the study drug on heart muscle thickness, the amount of drug that ends up in the blood, and the safety and tolerability of study drug in Noonan syndrome patients.An open label study to assess safety, tolerability, pharmacokinetics and pharmacodynamics of MEK162 in Noonan syndrome hypertrophic cardiomyopathy. Noonan syndrome hypertrophic cardiomyopathy
MedDRA version: 14.1;Level: PT;Classification code 10029748;Term: Noonan syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 14.1;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Code: MEK162Novartis Pharma Services AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
22United Kingdom;United States
16NCT01529944
(ClinicalTrials.gov)
September 20082/1/2012Genetic Testing of Noonan Subjects Previously Treated With Norditropin®. An Extension to Trial GHNOO-1658Genetic Testing of Noonan Subjects Previously Treated With Norditropin® in the GHNOO-1658 TrialGenetic Disorder;Noonan SyndromeDrug: somatropinNovo Nordisk A/SNULLCompletedN/AN/ABoth22Phase 3Sweden
17NCT00351221
(ClinicalTrials.gov)
May 200611/7/2006Research Study Using Recombinant Human Insulin-Like Growth Factor-1/Recombinant Human Insulin-Like Growth Factor Binding Protein-3 for Children With Noonan SyndromeA Phase 2, Open-Label, Multicenter, Clinical Trial to Evaluate the Pharmacokinetics, Safety and Efficacy of Recombinant Human Insulin-Like Growth Factor-1/Recombinant Human Insulin-Like Growth Factor Binding Protein-3 in Children With Growth Failure Due to Noonan SyndromeNoonan SyndromeDrug: rhIGF-1/rhIGFBP-3Insmed IncorporatedNULLTerminated2 Years16 YearsBoth24Phase 2United States
18NCT00960128
(ClinicalTrials.gov)
April 1, 200613/8/2009Observational Prospective Study on Patients Treated With Norditropin®NordiNet® International Outcome Study-Observational Prospective Study on Patients Treated With Norditropin®Growth Hormone Disorder;Growth Hormone Deficiency in Children;Adult Growth Hormone Deficiency;Genetic Disorder;Turner Syndrome;Foetal Growth Problem;Small for Gestational Age;Chronic Kidney Disease;Chronic Renal Insufficiency;Noonan SyndromeDrug: somatropinNovo Nordisk A/SNULLCompletedN/AN/AAll21249N/AArgentina;Belgium;Czechia;Denmark;Finland;France;Germany;Hungary;Ireland;Israel;Italy;Lithuania;Luxembourg;Netherlands;Norway;Russian Federation;Saudi Arabia;Serbia;Slovenia;Spain;Sweden;Switzerland;United Kingdom;Brazil;Czech Republic;Former Serbia and Montenegro
19EUCTR2005-000042-37-SE
(EUCTR)
11/07/200512/04/2005Norditropin Treatment in Subjects with Noonan Syndrome. Effects on Linear Growth and Final Height - Data Collection and Follow-up VisitNorditropin Treatment in Subjects with Noonan Syndrome. Effects on Linear Growth and Final Height - Data Collection and Follow-up Visit Noonan syndrome associated short stature
MedDRA version: 7.1;Level: PT;Classification code 10029748
Trade Name: Norditropin 24 IU
Product Name: Norditropin 24 IU
INN or Proposed INN: Somatropin
Trade Name: Norditropin SimpleXx
Product Name: Norditropin SimpleXx
INN or Proposed INN: Somatropin
INN or Proposed INN: Somatropin
INN or Proposed INN: Somatropin
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
Sweden
20NCT00452725
(ClinicalTrials.gov)
October 199723/3/2007Effect of MAXOMAT ® on the Growth of Small Children to NOONAN's SyndromeEffect of the Growth Hormone MAXOMAT ® on the Growth of Small Children and Adolescents (<-2 SD) Due to NOONAN's SyndromeNoonan SyndromeDrug: MAXOMAT ®, biosynthetic growth hormoneSanofiNULLCompleted3 Years15 YearsBoth36Phase 3France
21NCT01529840
(ClinicalTrials.gov)
June 19902/1/2012Somatropin Effect on Linear Growth and Final Height in Subjects With Noonan SyndromeNorditropin Treatment in Subjects With Noonan Syndrome. Effects on Linear Growth and Final Height - Data Collection and Follow-up VisitGenetic Disorder;Noonan SyndromeDrug: somatropinNovo Nordisk A/SNULLCompleted18 YearsN/AAll24Phase 3Sweden
22EUCTR2021-005607-13-IE
(EUCTR)
10/05/2022A research study to compare somapacitan once a week with Norditropin® once a day in children who need help to growA study comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® as well as evaluating long-term safety of somapacitan in a basket study design inchildren with short stature either born small for gestational age or with Turner syndrome,Noonan syndrome, or idiopathic short stature. Short stature born small for gestational age Turner syndromeNoonan syndromeIdiopathic short stature
MedDRA version: 20.0;Level: PT;Classification code 10045181;Term: Turner's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10029748;Term: Noonan syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 23.0;Level: LLT;Classification code 10066333;Term: Idiopathic short stature;System Organ Class: 100000004859
MedDRA version: 21.1;Classification code 10041093;Term: Small for gestational age;System Organ Class: 100000004868;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Sogroya 10 mg/1.5 mL solution for injection in pre-filled pen
INN or Proposed INN: Somapacitan
Other descriptive name: Somapacitan
Product Name: somapacitan 5 mg/1.5 mL PDS290
INN or Proposed INN: Somapacitan
Other descriptive name: Somapacitan
Product Name: Somapacitan 15 mg/1.5 mL PDS290
INN or Proposed INN: Somapacitan
Other descriptive name: Somapacitan
Trade Name: Norditropin FlexPro 10 mg/1.5 ml, solution for injection in pre-filled pen
INN or Proposed INN: Somatropin
Other descriptive name: Somatropin
Novo Nordisk A/SNULLNAFemale: yes
Male: yes
395Phase 3United States;Serbia;Saudi Arabia;Greece;Thailand;Ireland;Israel;Russian Federation;Switzerland;India;Malaysia;South Africa;Netherlands;China;Korea, Republic of;Finland;Austria;United Kingdom;Mexico;European Union;Canada;Brazil;Belgium;Poland;Japan
23EUCTR2021-005607-13-BE
(EUCTR)
07/06/2022A research study to compare somapacitan once a week with Norditropin® once a day in children who need help to growA study comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® as well as evaluating long-term safety of somapacitan in a basket study design inchildren with short stature either born small for gestational age or with Turner syndrome,Noonan syndrome, or idiopathic short stature. Short stature born small for gestational age Turner syndromeNoonan syndromeIdiopathic short stature
MedDRA version: 20.0;Level: PT;Classification code 10045181;Term: Turner's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10029748;Term: Noonan syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 23.0;Level: LLT;Classification code 10066333;Term: Idiopathic short stature;System Organ Class: 100000004859
MedDRA version: 21.1;Classification code 10041093;Term: Small for gestational age;System Organ Class: 100000004868;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Sogroya 10 mg/1.5 mL solution for injection in pre-filled pen
INN or Proposed INN: Somapacitan
Other descriptive name: Somapacitan
Trade Name: Sogroya 5 mg/1.5 mL solution for injection in pre-filled pen
Product Name: somapacitan 5 mg/1.5 mL PDS290
INN or Proposed INN: Somapacitan
Other descriptive name: Somapacitan
Product Name: Somapacitan 15 mg/1.5 mL PDS290
INN or Proposed INN: Somapacitan
Other descriptive name: Somapacitan
Trade Name: Norditropin FlexPro 10 mg/1.5 ml, solution for injection in pre-filled pen
INN or Proposed INN: Somatropin
Other descriptive name: Somatropin
Novo Nordisk A/SNULLNAFemale: yes
Male: yes
395Phase 3United States;Serbia;Saudi Arabia;Greece;Thailand;Ireland;Israel;Russian Federation;Switzerland;India;Malaysia;South Africa;Netherlands;China;Korea, Republic of;Finland;Austria;United Kingdom;Mexico;European Union;Canada;Brazil;Belgium;Poland;Japan
24EUCTR2021-005607-13-GR
(EUCTR)
25/05/2022A research study to compare somapacitan once a week with Norditropin® once a day in children who need help to growA study comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® as well as evaluating long-term safety of somapacitan in a basket study design inchildren with short stature either born small for gestational age or with Turner syndrome,Noonan syndrome, or idiopathic short stature. Short stature born small for gestational age Turner syndromeNoonan syndromeIdiopathic short stature
MedDRA version: 20.0;Level: PT;Classification code 10045181;Term: Turner's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10029748;Term: Noonan syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 23.0;Level: LLT;Classification code 10066333;Term: Idiopathic short stature;System Organ Class: 100000004859
MedDRA version: 21.1;Classification code 10041093;Term: Small for gestational age;System Organ Class: 100000004868;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Sogroya 10 mg/1.5 mL solution for injection in pre-filled pen
INN or Proposed INN: Somapacitan
Other descriptive name: Somapacitan
Product Name: somapacitan 5 mg/1.5 mL PDS290
INN or Proposed INN: Somapacitan
Other descriptive name: Somapacitan
Product Name: Somapacitan 15 mg/1.5 mL PDS290
INN or Proposed INN: Somapacitan
Other descriptive name: Somapacitan
Trade Name: Norditropin FlexPro 10 mg/1.5 ml, solution for injection in pre-filled pen
INN or Proposed INN: Somatropin
Other descriptive name: Somatropin
Novo Nordisk A/SNULLNAFemale: yes
Male: yes
395Phase 3United States;Serbia;Saudi Arabia;Greece;Thailand;Ireland;Israel;Russian Federation;Switzerland;India;Malaysia;South Africa;Netherlands;China;Korea, Republic of;Finland;Austria;United Kingdom;Mexico;European Union;Canada;Brazil;Belgium;Poland;Japan
25EUCTR2021-005607-13-PL
(EUCTR)
03/08/2022A research study to compare somapacitan once a week with Norditropin® once a day in children who need help to growA study comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® as well as evaluating long-term safety of somapacitan in a basket study design inchildren with short stature either born small for gestational age or with Turner syndrome,Noonan syndrome, or idiopathic short stature. Short stature born small for gestational age Turner syndromeNoonan syndromeIdiopathic short stature
MedDRA version: 20.0;Level: PT;Classification code 10045181;Term: Turner's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10029748;Term: Noonan syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 23.0;Level: LLT;Classification code 10066333;Term: Idiopathic short stature;System Organ Class: 100000004859
MedDRA version: 21.1;Classification code 10041093;Term: Small for gestational age;System Organ Class: 100000004868;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Sogroya 10 mg/1.5 mL solution for injection in pre-filled pen
INN or Proposed INN: Somapacitan
Other descriptive name: Somapacitan
Product Name: somapacitan 5 mg/1.5 mL PDS290
INN or Proposed INN: Somapacitan
Other descriptive name: Somapacitan
Product Name: Somapacitan 15 mg/1.5 mL PDS290
INN or Proposed INN: Somapacitan
Other descriptive name: Somapacitan
Trade Name: Norditropin FlexPro 10 mg/1.5 ml, solution for injection in pre-filled pen
INN or Proposed INN: Somatropin
Other descriptive name: Somatropin
Novo Nordisk A/SNULLNAFemale: yes
Male: yes
395Phase 3Russian Federation;United States;Malaysia;Thailand;Saudi Arabia;Greece;Netherlands;Austria;China;Ireland;Poland;Brazil;Korea, Republic of;Slovenia;Serbia;Bulgaria;Croatia;Japan;United Kingdom;Switzerland;India;Spain;Canada;Belgium;European Union;Finland;Mexico;South Africa;Israel;Germany