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. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05723835 (ClinicalTrials.gov) | February 1, 2023 | 29/1/2023 | A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9 | A 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 Stature | SGA;Turner Syndrome;Noonan Syndrome;ISS | Drug: Somapacitan | Novo Nordisk A/S | NULL | Recruiting | 10 Years | 18 Years | All | 48 | Phase 3 | United States;Korea, Republic of;Malaysia;Netherlands;Poland;Spain |
| 2 | EUCTR2021-005607-13-NL (EUCTR) | 06/12/2022 | 02/06/2022 | A research study to compare somapacitan once a week with Norditropin® once a day in children who need help to grow | A 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/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 395 | Phase 3 | United 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 | ||
| 3 | EUCTR2021-005607-13-DE (EUCTR) | 10/10/2022 | 12/05/2022 | A research study to compare somapacitan once a week with Norditropin® once a day in children who need help to grow | A 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/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 395 | Phase 3 | United 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 | ||
| 4 | NCT05330325 (ClinicalTrials.gov) | August 10, 2022 | 8/4/2022 | A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow | A 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 | SGA, Turner Syndrome, Noonan Syndrome, ISS | Drug: Somapacitan;Drug: Norditropin® | Novo Nordisk A/S | NULL | Recruiting | 2 Years | 10 Years | All | 399 | Phase 3 | United 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 |
| 5 | JPRN-jRCT2031220263 | 10/08/2022 | 10/08/2022 | A 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 | A 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) treatment | Suzuki Taiki | NULL | Recruiting | >= 2age 6month old | < 11age old | Both | 45 | Phase 3 | Austria;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 |
| 6 | EUCTR2021-005607-13-SI (EUCTR) | 20/06/2022 | 29/04/2022 | A research study to compare somapacitan once a week with Norditropin® once a day in children who need help to grow | A 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/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 395 | Phase 3 | Serbia;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 | ||
| 7 | NCT05308927 (ClinicalTrials.gov) | March 16, 2022 | 14/3/2022 | French Registry of Children Treated With Norditropin® for Short Stature Associated With Noonan Syndrome | French Registry of Children Treated With Norditropin® for Short Stature Associated With Noonan Syndrome | Noonan Syndrome | Drug: Norditropin | Novo Nordisk A/S | NULL | Enrolling by invitation | N/A | N/A | All | 221 | France | |
| 8 | NCT05202210 (ClinicalTrials.gov) | January 26, 2022 | 7/1/2022 | Constitution of a Biological Collection to Study the Pathophysiology in Noonan Syndrome | Constitution of a Biological Collection to Study the Pathophysiology in Noonan Syndrome and to Identify Predictive Factors of Disease Progression | Noonan Syndrome | Biological: blood and urine sampling | University Hospital, Toulouse | NULL | Recruiting | 18 Years | 99 Years | All | 100 | France | |
| 9 | NCT03435627 (ClinicalTrials.gov) | February 26, 2018 | 31/1/2018 | Post 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 Syndrome | Drug: Somatropin | Novo Nordisk A/S | NULL | Completed | 3 Years | N/A | All | 71 | Japan | |
| 10 | EUCTR2016-005022-10-DE (EUCTR) | 13/02/2018 | 09/11/2017 | Improvement of synaptic plasticity and cognitive function in RAS pathway disorders | Improvement 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 Medizin | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 2 | Germany | ||
| 11 | NCT02713945 (ClinicalTrials.gov) | January 25, 2017 | 9/3/2016 | Treatment With HMG-COA Reductase Inhibitor of Growth and Bone Abnormalities in Children With Noonan Syndrome | Treatment 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 | Noonan Syndrome | Drug: Simvastatin;Drug: Placebo | University Hospital, Toulouse | NULL | Completed | 6 Years | 16 Years | All | 53 | Phase 3 | France |
| 12 | EUCTR2016-000647-14-FR (EUCTR) | 23/05/2016 | 30/03/2016 | Treatment with simvastatin of growth and bone abnormalities in children with Noonan syndrome | Treatment 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 Toulouse | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 62 | Phase 3 | France | ||
| 13 | NCT01927861 (ClinicalTrials.gov) | August 19, 2013 | 20/8/2013 | Investigating the Long-term Efficacy and Safety of Two Doses of NN-220 (Somatropin) in Short Stature Due to Noonan Syndrome | A 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 Syndrome | Genetic Disorder;Noonan Syndrome | Drug: somatropin | Novo Nordisk A/S | NULL | Completed | 3 Years | 10 Years | All | 51 | Phase 3 | Japan |
| 14 | NCT01556568 (ClinicalTrials.gov) | February 2012 | 15/3/2012 | Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MEK162 in Noonan Syndrome Hypertrophic Cardiomyopathy | An Open Label Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MEK162 in Noonan Syndrome Hypertrophic Cardiomyopathy | Cardiomegaly | Drug: MEK162 | Array Biopharma, now a wholly owned subsidiary of Pfizer | NULL | Withdrawn | 18 Years | 65 Years | All | 0 | Phase 2 | United States;United Kingdom |
| 15 | EUCTR2011-003392-10-GB (EUCTR) | 23/01/2012 | 24/08/2011 | A 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: MEK162 | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 22 | United Kingdom;United States | |||
| 16 | NCT01529944 (ClinicalTrials.gov) | September 2008 | 2/1/2012 | Genetic Testing of Noonan Subjects Previously Treated With Norditropin®. An Extension to Trial GHNOO-1658 | Genetic Testing of Noonan Subjects Previously Treated With Norditropin® in the GHNOO-1658 Trial | Genetic Disorder;Noonan Syndrome | Drug: somatropin | Novo Nordisk A/S | NULL | Completed | N/A | N/A | Both | 22 | Phase 3 | Sweden |
| 17 | NCT00351221 (ClinicalTrials.gov) | May 2006 | 11/7/2006 | Research Study Using Recombinant Human Insulin-Like Growth Factor-1/Recombinant Human Insulin-Like Growth Factor Binding Protein-3 for Children With Noonan Syndrome | A 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 Syndrome | Noonan Syndrome | Drug: rhIGF-1/rhIGFBP-3 | Insmed Incorporated | NULL | Terminated | 2 Years | 16 Years | Both | 24 | Phase 2 | United States |
| 18 | NCT00960128 (ClinicalTrials.gov) | April 1, 2006 | 13/8/2009 | Observational 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 Syndrome | Drug: somatropin | Novo Nordisk A/S | NULL | Completed | N/A | N/A | All | 21249 | N/A | Argentina;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 |
| 19 | EUCTR2005-000042-37-SE (EUCTR) | 11/07/2005 | 12/04/2005 | Norditropin Treatment in Subjects with Noonan Syndrome. Effects on Linear Growth and Final Height - Data Collection and Follow-up Visit | Norditropin 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/S | NULL | Not Recruiting | Female: yes Male: yes | Sweden | ||||
| 20 | NCT00452725 (ClinicalTrials.gov) | October 1997 | 23/3/2007 | Effect of MAXOMAT ® on the Growth of Small Children to NOONAN's Syndrome | Effect of the Growth Hormone MAXOMAT ® on the Growth of Small Children and Adolescents (<-2 SD) Due to NOONAN's Syndrome | Noonan Syndrome | Drug: MAXOMAT ®, biosynthetic growth hormone | Sanofi | NULL | Completed | 3 Years | 15 Years | Both | 36 | Phase 3 | France |
| 21 | NCT01529840 (ClinicalTrials.gov) | June 1990 | 2/1/2012 | Somatropin Effect on Linear Growth and Final Height in Subjects With Noonan Syndrome | Norditropin Treatment in Subjects With Noonan Syndrome. Effects on Linear Growth and Final Height - Data Collection and Follow-up Visit | Genetic Disorder;Noonan Syndrome | Drug: somatropin | Novo Nordisk A/S | NULL | Completed | 18 Years | N/A | All | 24 | Phase 3 | Sweden |
| 22 | EUCTR2021-005607-13-BE (EUCTR) | 07/06/2022 | A research study to compare somapacitan once a week with Norditropin® once a day in children who need help to grow | A 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/S | NULL | NA | Female: yes Male: yes | 395 | Phase 3 | United 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 | |||
| 23 | EUCTR2021-005607-13-GR (EUCTR) | 25/05/2022 | A research study to compare somapacitan once a week with Norditropin® once a day in children who need help to grow | A 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/S | NULL | NA | Female: yes Male: yes | 395 | Phase 3 | United 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 | |||
| 24 | EUCTR2021-005607-13-PL (EUCTR) | 03/08/2022 | A research study to compare somapacitan once a week with Norditropin® once a day in children who need help to grow | A 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/S | NULL | NA | Female: yes Male: yes | 395 | Phase 3 | Russian 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 | |||
| 25 | EUCTR2021-005607-13-IE (EUCTR) | 10/05/2022 | A research study to compare somapacitan once a week with Norditropin® once a day in children who need help to grow | A 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/S | NULL | NA | Female: yes Male: yes | 395 | Phase 3 | United 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 |