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-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 |