Comparison of Chronocort Versus Standard Hydrocortisone Replacement Therapy in Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia

PHASE3CompletedINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

May 24, 2022

Primary Completion Date

February 2, 2024

Study Completion Date

February 2, 2024

Conditions
Congenital Adrenal Hyperplasia
Interventions
DRUG

Chronocort

Over-encapsulated hydrocortisone modified-release capsule for oral administration.

DRUG

Cortef

Over-encapsulated hydrocortisone immediate-release tablet for oral administration.

OTHER

Placebo

Matching placebo

Trial Locations (21)

14033

Diurnal Investigational Site in Caen, Caen

31059

Diurnal Investigational Site in Toulouse (Children's Hospital), Toulouse

Diurnal Investigational Site in Toulouse, Toulouse

32207

Diurnal Investigational Site in Jacksonville, Jacksonville

33604

Diurnal Investigational Site in Pessac, Bordeaux

48109

Diurnal Investigational Site in Michigan, Ann Arbor

52224

Diurnal Investigational Site in Iowa, Iowa City

53226

Diurnal Investigational Site in Milwaukee, Milwaukee

55901

Diurnal Investigational Site in Rochester, Rochester

69677

Diurnal Investigational Site in Bron, Lyon

75235

Diurnal Investigational Site in Dallas, Dallas

75651

Diurnal Investigational Site in Paris, Paris

89148

Diurnal Investigational Site in Nevada, Las Vegas

90027

Diurnal Investigational Site in Los Angeles, Los Angeles

92868

Diurnal Investigational Site in Orange, Orange

98105

Diurnal Investigational Site in Seattle, Seattle

20892-1932

Diurnal Investigational Site in Maryland, Bethesda

241-0811

Diurnal Investigational Site in Asahi-ku, Yokohama

113-8519

Diurnal Investigational Site in Yushima, Bunkyō-Ku

157-8535

Diurnal Investigational Site in Okura, Setagaya-Ku

162-8655

Diurnal Investigational Site in Toyama, Shinjuku-Ku

All Listed Sponsors
lead

Neurocrine UK Limited

INDUSTRY