DIUR-005
Research type
Research Study
Full 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.
IRAS ID
188121
Contact name
Richard Ross
Contact email
Sponsor organisation
Diurnal Ltd
Eudract number
2015-000711-40
Duration of Study in the UK
1 years, 1 months, 1 days
Research summary
The glucocorticoid medications currently used to treat CAH are like cortisol, but they cannot simulate natural cortisol in terms of how it is produced in the body. This is because cortisol is normally released in different amounts throughout the day with a pulse, or burst, during the early morning hours and very low amounts in the body in the evening. Chronocort® has been designed so that the amounts of cortisol in the body more closely mimic the human body’s normal release pattern of cortisol. \n\nThe purpose of this research study is to compare the safety and effectiveness of Chronocort® with current glucocorticoid treatment regimens in the treatment of CAH over a 6 month period. \n\nPatients will be invited if they have Classic CAH, which results in a failure to produce enough cortisol, and are currently undergoing standard treatment for CAH.\n\nThe study will seek to understand if Chronocort® is better at managing CAH by comparing patients taking their normal treatment to those who are treated with Chronocort®. A computer system will randomly assign patients to either continue with their standard treatment or switch to Chronocort®. In order to gather comparable data, patients will undergo a number of tests through out the study including four 24 hour hormone profiles.\n
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
15/NW/0868
Date of REC Opinion
19 Nov 2015
REC opinion
Further Information Favourable Opinion