Trial Outcomes & Findings for Comparison of Two Forms of Hydrocortisone in Patients With Congenital Adrenal Hyperplasia (NCT NCT00519818)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

20 participants

Primary outcome timeframe

Cortef after one week, Chronocort after one month

Results posted on

2022-04-26

Participant Flow

Participant milestones

Participant milestones
Measure	Cortef Then Chronocort Hydrocortisone immediate release tablet treatment then Modified release hydrocortisone
Overall Study STARTED	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Two Forms of Hydrocortisone in Patients With Congenital Adrenal Hyperplasia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cortef Then Chronocort n=14 Participants Hydrocortisone immediate release 3 times daily total dose 30mg for 7 days, then hydrocortisone modified release tablet 30mg once nightly for 28days
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	26.8 years STANDARD_DEVIATION 3.8 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants

PRIMARY outcome

Timeframe: Cortef after one week, Chronocort after one month

Population: Per protocol

Outcome measures

Outcome measures
Measure	Cortef n=14 Participants Hydrocortisone immediate release tablet	Chronocort n=14 Participants Hydrocortisone modified release tablet treatment
Chronocort vs. Cortef Cortisol Concentrations (AUC Over 24 Hours - Time Points 0,.5,1,1.5,2,3,4,5,6,7,8,10,10.5,11, 11.5,12,13,15,17,17.5,18,18.5,19,20,22,24 Post Dose).	5380 h*nmol/l Standard Error 414	3973 h*nmol/l Standard Error 166

SECONDARY outcome

Timeframe: Cortef after one week compared with Chronocort after one month

Outcome measures

Outcome measures
Measure	Cortef n=14 Participants Hydrocortisone immediate release tablet	Chronocort n=14 Participants Hydrocortisone modified release tablet treatment
17 Hydroxyprogesterone at 08.00 Hours	16.4 nmol/l Standard Deviation 27.9	86.9 nmol/l Standard Deviation 181.7

Adverse Events

Chronocort

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Cortef

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Chronocort n=14 participants at risk Hydrocortisone modified release tablet	Cortef n=14 participants at risk Hydrocortisone immediate release tablet
Nervous system disorders Headache	28.6% 4/14 • Number of events 4 • Adverse events for each subject were followed for 1 week in Cortef, 4 weeks on Chronocort and 4 weeks follow-up.	21.4% 3/14 • Number of events 4 • Adverse events for each subject were followed for 1 week in Cortef, 4 weeks on Chronocort and 4 weeks follow-up.

Additional Information

Richard JM Ross

Diurnal Ltd

Phone: 0044 114 2712386

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place