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 | 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 | ||
| 2 | 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 | ||
| 3 | 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 |
| 4 | 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 | ||
| 5 | 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 | |
| 6 | 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 |
| 7 | 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 |
| 8 | 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 |
| 9 | 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 | ||||
| 10 | 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 |
| 11 | 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 |
| 12 | 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 | |||
| 13 | 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 | |||
| 14 | 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 | |||
| 15 | 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 |