NN8640 ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
78下垂体前葉機能低下症1

78. 下垂体前葉機能低下症


臨床試験数 : 492 薬物数 : 341 - (DrugBank : 47) / 標的遺伝子数 : 45 - 標的パスウェイ数 : 100
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-000231-27-IT
(EUCTR)
19/04/201930/07/2021A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a dayA trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 Growth hormone deficiency in children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: somapacitan 5 mg/1.5ml PDS290
Product Code: [NN8640]
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 10 mg/1.5ml PDS290S
Product Code: [NN8640]
INN or Proposed INN: Somapacitan
Other descriptive name: SOMAPACITAN
Product Name: somapacitan 15 mg/1.5ml PDS290
Product Code: [NN8640]
INN or Proposed INN: somapacitan
Other descriptive name: SOMAPACITAN
Trade Name: Norditropin FlexPro 10 mg/1.5 ml
Product Name: Norditropin FlexPro 10 mg/1.5 ml
Product Code: [N/A]
INN or Proposed INN: somatropin
Other descriptive name: somatropin
NOVO NORDISK. S.P.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 3United States;Estonia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Latvia;Korea, Republic of;Slovenia;Austria;United Kingdom;Hungary;Canada;Poland;Germany;Norway;Algeria;Japan