Dexamethasone 0.5mg Tablet ( DrugBank: Dexamethasone )

1 disease
告示番号疾患名（ページ内リンク）臨床試験数
81先天性副腎皮質酵素欠損症1

81. 先天性副腎皮質酵素欠損症

臨床試験数 : 87 /  薬物数 : 87 - (DrugBank : 23) / 標的遺伝子数 : 12 - 標的パスウェイ数 : 68
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1EUCTR2015-000711-40-DE
(EUCTR)		23/05/201606/10/2015Chronocort®, a slow release medicinal preparation of hydrocortisone, will be compared with currently used glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia seeking to assess its safety, tolerability and effectiveness.A Phase III study of efficacy, safety and tolerability of Chronocort® compared with standard glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia. Congenital adrenal hyperplasia (CAH); is generally due to 21-hydroxylase deficiency, is a disease of the adrenal cortex characterised by cortisol deficiency with or without aldosterone deficiency, and androgen excess. Subjects with CAH are at risk of developing a number of clinical manifestations, such as obesity in children, insulin resistance, and polycystic ovaries, which may contribute to infertility in women with CAH. Oligomenorrhoea or amenorrhoea may be present in adolescence.
MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]		Product Name: Chronocort® 5 mg
Product Code: DIURF-006
INN or Proposed INN: HYDROCORTISONE
Other descriptive name: Cortisol
Product Name: Hydrocortisone 10mg Tablet
INN or Proposed INN: Hydrocortisone
Other descriptive name: HYDROCORTISONE
Product Name: Dexamethasone 0.5mg Tablet
INN or Proposed INN: DEXAMETHASONE
Product Name: Prednisolone 5mg Tablet
INN or Proposed INN: Prednisolone
Other descriptive name: PREDNISOLONE
Product Name: Chronocort® 10 mg
Product Code: DIURF-006
INN or Proposed INN: HYDROCORTISONE
Other descriptive name: Cortisol
Product Name: Chronocort® 20 mg		Diurnal LtdNULLNot Recruiting Female: yes
Male: yes		120 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Denmark;Netherlands;Germany;United Kingdom;Sweden