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

  
10 trials found
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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Inclusion_
agemin
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agemax
Inclusion_
gender
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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
7EUCTR2021-005607-13-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
8EUCTR2021-005607-13-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
9EUCTR2021-005607-13-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
10EUCTR2021-005607-13-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