WHO ICTRP trial
Chronocort®, a slow release medicinal preparation of hydrocortisone, will be…
EUCTR2015-000711-40-GB · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2015-000711-40-GB |
|---|---|
| Public title | Chronocort®, 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. |
| Scientific title | A Phase III study of efficacy, safety and tolerability of Chronocort® compared with standard glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia. |
| Primary sponsor | Diurnal Ltd |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | France;United States;Denmark;Netherlands;Germany;United Kingdom;Sweden |
| Conditions | 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… |
| Interventions | Product Name: Chronocort® Product Code: DIURF-006 Pharmaceutical Form: Capsule INN or Proposed INN: HYDROCORTISONE CAS Number: 50-23-7 Other descriptive name: Cortisol Concentration unit: mg milligram(s) Concentration type: range… |
| Registration date | Jul 28, 2015 |
| Target size | 120 |
| Secondary IDs | DIUR-005 |
| Registry page | clinicaltrialsregister.eu |
At a glance
- Yes Results available
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About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: