Trial Outcomes & Findings for Comparison of Chronocort Versus Standard Hydrocortisone Replacement Therapy in Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia (NCT NCT05063994)
NCT ID: NCT05063994
Last Updated: 2025-02-25
Results Overview
Biochemical response was defined as a participant who a) was in biochemical control at the 08:00 assessment and b) was receiving a total daily dose of hydrocortisone of not more than 25 mg if the participant was in biochemical control at baseline or not more than 30 mg if the participant was not in biochemical control at baseline. Biochemical control was defined as both a 17-OHP concentration equal to or below the upper limit for optimal control (1200 ng/dL \[36.4 nmol/L\]) and an A4 concentration equal to or below the upper limit of the reference range (150 ng/dL \[5.2 nmol/L\] for men and 200 ng/dL \[7.0 nmol/L\] for women). Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
55 participants
Primary outcome timeframe
Week 28
Results posted on
2025-02-25
Participant Flow
Participants received immediate-release hydrocortisone (IRHC; Cortef) during the run-in therapy for 4 weeks prior to randomization. Once eligibility for the study was confirmed at the Baseline visit, participants were randomized on a 1:1 basis (Chronocort:Cortef). 55 participants entered the run-in period and 53 were randomized to treatment.
Participant milestones
| Measure |
Cortef Run-In
Participants received Cortef 30 milligrams (mg) total daily dose during the run-in therapy for 4 weeks prior to randomization.
|
Chronocort
Participants received Chronocort at a starting dose of 30 mg, with dose adjustments down to 25, 20, or 15 mg based on adrenal insufficiency symptoms and androgen levels. Placebo was used for dose adjustment to maintain blinding.
|
Cortef
Participants received Cortef at a starting dose of 30 mg, with dose adjustments down to 25, 20, or 15 mg based on adrenal insufficiency symptoms and androgen levels. Placebo was used for dose adjustment to maintain blinding.
|
|---|---|---|---|
|
Cortef Run-In
STARTED
|
55
|
0
|
0
|
|
Cortef Run-In
COMPLETED
|
53
|
0
|
0
|
|
Cortef Run-In
NOT COMPLETED
|
2
|
0
|
0
|
|
Treatment
STARTED
|
0
|
25
|
28
|
|
Treatment
Full Analysis Set (FAS) Population
|
0
|
25
|
28
|
|
Treatment
COMPLETED
|
0
|
25
|
25
|
|
Treatment
NOT COMPLETED
|
0
|
0
|
3
|
Reasons for withdrawal
| Measure |
Cortef Run-In
Participants received Cortef 30 milligrams (mg) total daily dose during the run-in therapy for 4 weeks prior to randomization.
|
Chronocort
Participants received Chronocort at a starting dose of 30 mg, with dose adjustments down to 25, 20, or 15 mg based on adrenal insufficiency symptoms and androgen levels. Placebo was used for dose adjustment to maintain blinding.
|
Cortef
Participants received Cortef at a starting dose of 30 mg, with dose adjustments down to 25, 20, or 15 mg based on adrenal insufficiency symptoms and androgen levels. Placebo was used for dose adjustment to maintain blinding.
|
|---|---|---|---|
|
Cortef Run-In
Withdrawal of Consent
|
1
|
0
|
0
|
|
Cortef Run-In
Did not meet the inclusion/exclusion criteria at end of Run-In
|
1
|
0
|
0
|
|
Treatment
Physician Decision
|
0
|
0
|
1
|
|
Treatment
Withdrawal by Subject
|
0
|
0
|
1
|
|
Treatment
Withdrawal of Consent
|
0
|
0
|
1
|
Baseline Characteristics
Participants in the FAS population who had an A4 assessment at the baseline visit.
Baseline characteristics by cohort
| Measure |
Chronocort
n=25 Participants
Participants received Chronocort at a starting dose of 30 mg, with dose adjustments down to 25, 20, or 15 mg based on adrenal insufficiency symptoms and androgen levels. Placebo was used for dose adjustment to maintain blinding.
|
Cortef
n=28 Participants
Participants received Cortef at a starting dose of 30 mg, with dose adjustments down to 25, 20, or 15 mg based on adrenal insufficiency symptoms and androgen levels. Placebo was used for dose adjustment to maintain blinding.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.7 years
STANDARD_DEVIATION 14.68 • n=25 Participants
|
31.6 years
STANDARD_DEVIATION 13.02 • n=28 Participants
|
34.0 years
STANDARD_DEVIATION 13.93 • n=53 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=25 Participants
|
16 Participants
n=28 Participants
|
32 Participants
n=53 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=25 Participants
|
12 Participants
n=28 Participants
|
21 Participants
n=53 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=25 Participants
|
3 Participants
n=28 Participants
|
5 Participants
n=53 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=25 Participants
|
16 Participants
n=28 Participants
|
31 Participants
n=53 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=25 Participants
|
9 Participants
n=28 Participants
|
17 Participants
n=53 Participants
|
|
Race/Ethnicity, Customized
White
|
13 Participants
n=25 Participants
|
12 Participants
n=28 Participants
|
25 Participants
n=53 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=25 Participants
|
2 Participants
n=28 Participants
|
3 Participants
n=53 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=25 Participants
|
5 Participants
n=28 Participants
|
9 Participants
n=53 Participants
|
|
Race/Ethnicity, Customized
Not Reportable
|
6 Participants
n=25 Participants
|
6 Participants
n=28 Participants
|
12 Participants
n=53 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=25 Participants
|
3 Participants
n=28 Participants
|
4 Participants
n=53 Participants
|
|
17-Hydroxyprogesterone (17-OHP) Level
|
3470.48 nanograms (ng)/deciliters (dL)
n=25 Participants
|
5595.36 nanograms (ng)/deciliters (dL)
n=28 Participants
|
4593.06 nanograms (ng)/deciliters (dL)
n=53 Participants
|
|
Androstenedione (A4) Level
|
173.30 ng/dL
n=25 Participants • Participants in the FAS population who had an A4 assessment at the baseline visit.
|
483.09 ng/dL
n=27 Participants • Participants in the FAS population who had an A4 assessment at the baseline visit.
|
334.15 ng/dL
n=52 Participants • Participants in the FAS population who had an A4 assessment at the baseline visit.
|
PRIMARY outcome
Timeframe: Week 28Population: FAS: All participants with CAH who were randomized into the study and who received at least 1 dose of study drug.
Biochemical response was defined as a participant who a) was in biochemical control at the 08:00 assessment and b) was receiving a total daily dose of hydrocortisone of not more than 25 mg if the participant was in biochemical control at baseline or not more than 30 mg if the participant was not in biochemical control at baseline. Biochemical control was defined as both a 17-OHP concentration equal to or below the upper limit for optimal control (1200 ng/dL \[36.4 nmol/L\]) and an A4 concentration equal to or below the upper limit of the reference range (150 ng/dL \[5.2 nmol/L\] for men and 200 ng/dL \[7.0 nmol/L\] for women). Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
Outcome measures
| Measure |
Chronocort
n=25 Participants
Participants received Chronocort at a starting dose of 30 mg, with dose adjustments down to 25, 20, or 15 mg based on adrenal insufficiency symptoms and androgen levels. Placebo was used for dose adjustment to maintain blinding.
|
Cortef
n=28 Participants
Participants received Cortef at a starting dose of 30 mg, with dose adjustments down to 25, 20, or 15 mg based on adrenal insufficiency symptoms and androgen levels. Placebo was used for dose adjustment to maintain blinding.
|
|---|---|---|
|
Percentage of Participants Who Were Biochemical Responders at Week 28
|
40.0 percentage of participants
|
14.3 percentage of participants
|
SECONDARY outcome
Timeframe: Week 28Population: FAS: All participants with CAH who were randomized into the study and who received at least 1 dose of study drug.
Dose response was defined as a participant who a) was receiving a total daily dose of hydrocortisone of not more than 25 mg and b) was in biochemical control at the 08:00 assessment. Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
Outcome measures
| Measure |
Chronocort
n=25 Participants
Participants received Chronocort at a starting dose of 30 mg, with dose adjustments down to 25, 20, or 15 mg based on adrenal insufficiency symptoms and androgen levels. Placebo was used for dose adjustment to maintain blinding.
|
Cortef
n=28 Participants
Participants received Cortef at a starting dose of 30 mg, with dose adjustments down to 25, 20, or 15 mg based on adrenal insufficiency symptoms and androgen levels. Placebo was used for dose adjustment to maintain blinding.
|
|---|---|---|
|
Percentage of Participants Who Were Dose Responders at Week 28
|
36.0 percentage of participants
|
10.7 percentage of participants
|
SECONDARY outcome
Timeframe: Week 28Population: FAS: All participants with CAH who were randomized into the study and who received at least 1 dose of study drug.
Least squares (LS) mean was assessed using mixed model repeated measures (MMRM). Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
Outcome measures
| Measure |
Chronocort
n=25 Participants
Participants received Chronocort at a starting dose of 30 mg, with dose adjustments down to 25, 20, or 15 mg based on adrenal insufficiency symptoms and androgen levels. Placebo was used for dose adjustment to maintain blinding.
|
Cortef
n=28 Participants
Participants received Cortef at a starting dose of 30 mg, with dose adjustments down to 25, 20, or 15 mg based on adrenal insufficiency symptoms and androgen levels. Placebo was used for dose adjustment to maintain blinding.
|
|---|---|---|
|
Total Daily Dose of Hydrocortisone at Week 28
|
20.2 mg
Interval 17.8 to 22.6
|
26.0 mg
Interval 23.7 to 28.3
|
SECONDARY outcome
Timeframe: Baseline and Week 28Population: FAS: All participants with CAH who were randomized into the study and who received at least 1 dose of study drug. Participants with evaluable data for the endpoint were analyzed for this outcome measure.
Biochemical control was defined as both a 17-OHP concentration (assessed at 08:00) equal to or below the upper limit for optimal control (1200 ng/dL \[36.4 nmol/L\]) and an A4 concentration equal to or below the upper limit of the reference range (150 ng/dL \[5.2 nmol/L\] for men and 200 ng/dL \[7.0 nmol/L\] for women). Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
Outcome measures
| Measure |
Chronocort
n=25 Participants
Participants received Chronocort at a starting dose of 30 mg, with dose adjustments down to 25, 20, or 15 mg based on adrenal insufficiency symptoms and androgen levels. Placebo was used for dose adjustment to maintain blinding.
|
Cortef
n=27 Participants
Participants received Cortef at a starting dose of 30 mg, with dose adjustments down to 25, 20, or 15 mg based on adrenal insufficiency symptoms and androgen levels. Placebo was used for dose adjustment to maintain blinding.
|
|---|---|---|
|
Number of Participants in Biochemical Control
Baseline
|
13 Participants
|
8 Participants
|
|
Number of Participants in Biochemical Control
Week 28
|
10 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 28Population: FAS: All participants with CAH who were randomized into the study and who received at least 1 dose of study drug. Participants with evaluable data for the endpoint were analyzed for this outcome measure.
LS mean was assessed using analysis of covariance (ANCOVA). Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
Outcome measures
| Measure |
Chronocort
n=25 Participants
Participants received Chronocort at a starting dose of 30 mg, with dose adjustments down to 25, 20, or 15 mg based on adrenal insufficiency symptoms and androgen levels. Placebo was used for dose adjustment to maintain blinding.
|
Cortef
n=25 Participants
Participants received Cortef at a starting dose of 30 mg, with dose adjustments down to 25, 20, or 15 mg based on adrenal insufficiency symptoms and androgen levels. Placebo was used for dose adjustment to maintain blinding.
|
|---|---|---|
|
Change From Baseline in Mean of 08:00 and 13:00 17-OHP Levels at Week 28
|
-1223.91 ng/dL
Interval -2897.42 to 449.6
|
1612.17 ng/dL
Interval -61.34 to 3285.68
|
SECONDARY outcome
Timeframe: Baseline, Week 28Population: FAS: All participants with CAH who were randomized into the study and who received at least 1 dose of study drug. Participants with evaluable data for the endpoint were analyzed for this outcome measure.
LS mean was assessed using ANCOVA. Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
Outcome measures
| Measure |
Chronocort
n=25 Participants
Participants received Chronocort at a starting dose of 30 mg, with dose adjustments down to 25, 20, or 15 mg based on adrenal insufficiency symptoms and androgen levels. Placebo was used for dose adjustment to maintain blinding.
|
Cortef
n=25 Participants
Participants received Cortef at a starting dose of 30 mg, with dose adjustments down to 25, 20, or 15 mg based on adrenal insufficiency symptoms and androgen levels. Placebo was used for dose adjustment to maintain blinding.
|
|---|---|---|
|
Change From Baseline in Mean of 08:00 and 13:00 A4 Levels at Week 28
|
-4.85 ng/dL
Interval -115.57 to 105.86
|
146.13 ng/dL
Interval 35.42 to 256.85
|
SECONDARY outcome
Timeframe: Week 28Population: FAS: All participants with CAH who were randomized into the study and who received at least 1 dose of study drug. Only female participants of childbearing potential with evaluable data for the endpoint were analyzed for this outcome measure.
Data are presented for the number of participants with more than monthly menstrual cycles, monthly menstrual cycles, and number of participants with oligomenorrhoea and amenorrhoea. Oligomenorrhoea was defined as fewer than 9 menstrual cycles per year or cycle length \>35 days and amenorrhoea as absent menses for ≥ 3 months. Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
Outcome measures
| Measure |
Chronocort
n=14 Participants
Participants received Chronocort at a starting dose of 30 mg, with dose adjustments down to 25, 20, or 15 mg based on adrenal insufficiency symptoms and androgen levels. Placebo was used for dose adjustment to maintain blinding.
|
Cortef
n=12 Participants
Participants received Cortef at a starting dose of 30 mg, with dose adjustments down to 25, 20, or 15 mg based on adrenal insufficiency symptoms and androgen levels. Placebo was used for dose adjustment to maintain blinding.
|
|---|---|---|
|
Number of Participants With Menstrual Regularity (Females of Childbearing Potential Only) at Week 28
More than Monthly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Menstrual Regularity (Females of Childbearing Potential Only) at Week 28
Monthly
|
9 Participants
|
2 Participants
|
|
Number of Participants With Menstrual Regularity (Females of Childbearing Potential Only) at Week 28
Oligomenorrhoea
|
2 Participants
|
4 Participants
|
|
Number of Participants With Menstrual Regularity (Females of Childbearing Potential Only) at Week 28
Amenorrhoea
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 28Population: FAS: All participants with CAH who were randomized into the study and who received at least 1 dose of study drug. Only male participants with evaluable data for the endpoint were analyzed for this outcome measure.
LS mean was assessed using ANCOVA. Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
Outcome measures
| Measure |
Chronocort
n=9 Participants
Participants received Chronocort at a starting dose of 30 mg, with dose adjustments down to 25, 20, or 15 mg based on adrenal insufficiency symptoms and androgen levels. Placebo was used for dose adjustment to maintain blinding.
|
Cortef
n=10 Participants
Participants received Cortef at a starting dose of 30 mg, with dose adjustments down to 25, 20, or 15 mg based on adrenal insufficiency symptoms and androgen levels. Placebo was used for dose adjustment to maintain blinding.
|
|---|---|---|
|
Change From Baseline in Luteinizing Hormone Levels (Males Only) at Week 28
|
0.15 mIU/mL
Interval -0.71 to 1.02
|
-1.19 mIU/mL
Interval -2.01 to -0.37
|
SECONDARY outcome
Timeframe: Week 28Population: FAS: All participants with CAH who were randomized into the study and who received at least 1 dose of study drug. Only male participants with evaluable data for the endpoint were analyzed for this outcome measure.
Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
Outcome measures
| Measure |
Chronocort
n=4 Participants
Participants received Chronocort at a starting dose of 30 mg, with dose adjustments down to 25, 20, or 15 mg based on adrenal insufficiency symptoms and androgen levels. Placebo was used for dose adjustment to maintain blinding.
|
Cortef
n=5 Participants
Participants received Cortef at a starting dose of 30 mg, with dose adjustments down to 25, 20, or 15 mg based on adrenal insufficiency symptoms and androgen levels. Placebo was used for dose adjustment to maintain blinding.
|
|---|---|---|
|
Percent Change From Baseline in Size of Testicular Adrenal Rest Tumors at Week 28 (Males Only)
|
-7.67 percent change
Standard Deviation 9.220
|
-0.90 percent change
Standard Deviation 1.810
|
SECONDARY outcome
Timeframe: Baseline, Week 28Population: FAS: All participants with CAH who were randomized into the study and who received at least 1 dose of study drug. Only female participants with evaluable data for the endpoint were analyzed for this outcome measure.
Ferriman-Gallwey score is a method used to assess and quantify hirsutism in women. A total score \< 8 is considered normal whereas a score of 8 to 15 indicates mild hirsutism. A score \>15 indicates moderate or severe hirsutism. The Ferriman-Gallwey score ranged from 0 to 36. Higher score indicated more hirsutism. Change from baseline is reported (negative change from baseline indicated improvement). LS mean was assessed using ANCOVA. Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
Outcome measures
| Measure |
Chronocort
n=16 Participants
Participants received Chronocort at a starting dose of 30 mg, with dose adjustments down to 25, 20, or 15 mg based on adrenal insufficiency symptoms and androgen levels. Placebo was used for dose adjustment to maintain blinding.
|
Cortef
n=13 Participants
Participants received Cortef at a starting dose of 30 mg, with dose adjustments down to 25, 20, or 15 mg based on adrenal insufficiency symptoms and androgen levels. Placebo was used for dose adjustment to maintain blinding.
|
|---|---|---|
|
Change From Baseline in Hirsutism at Week 28 Using the Ferriman-Gallwey Score (Females Only) at Week 28
|
-1.0 score on a scale
Interval -2.5 to 0.6
|
-1.2 score on a scale
Interval -3.0 to 0.5
|
SECONDARY outcome
Timeframe: Baseline, Week 28Population: FAS: All participants with CAH who were randomized into the study and who received at least 1 dose of study drug. Only female participants with evaluable data for the endpoint were analyzed for this outcome measure.
Acne severity was assessed according to GEA scale, which ranged from 0 (Clear. No lesions) to 5 (Very severe). Higher score indicated higher severity of acne. Change from baseline is reported (negative change from baseline indicated improvement). LS mean was assessed using ANCOVA. Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
Outcome measures
| Measure |
Chronocort
n=16 Participants
Participants received Chronocort at a starting dose of 30 mg, with dose adjustments down to 25, 20, or 15 mg based on adrenal insufficiency symptoms and androgen levels. Placebo was used for dose adjustment to maintain blinding.
|
Cortef
n=13 Participants
Participants received Cortef at a starting dose of 30 mg, with dose adjustments down to 25, 20, or 15 mg based on adrenal insufficiency symptoms and androgen levels. Placebo was used for dose adjustment to maintain blinding.
|
|---|---|---|
|
Change From Baseline in Acne Using the Global Evaluation Acne (GEA) Scale (Females Only) at Week 28
|
-0.3 score on a scale
Interval -0.5 to -0.1
|
-0.2 score on a scale
Interval -0.4 to 0.0
|
SECONDARY outcome
Timeframe: Baseline, Week 28Population: FAS: All participants with CAH who were randomized into the study and who received at least 1 dose of study drug. Participants with evaluable data for the endpoint were analyzed for this outcome measure.
LS mean was assessed by ANCOVA. Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
Outcome measures
| Measure |
Chronocort
n=22 Participants
Participants received Chronocort at a starting dose of 30 mg, with dose adjustments down to 25, 20, or 15 mg based on adrenal insufficiency symptoms and androgen levels. Placebo was used for dose adjustment to maintain blinding.
|
Cortef
n=24 Participants
Participants received Cortef at a starting dose of 30 mg, with dose adjustments down to 25, 20, or 15 mg based on adrenal insufficiency symptoms and androgen levels. Placebo was used for dose adjustment to maintain blinding.
|
|---|---|---|
|
Change From Baseline in Glycated Hemoglobin (HbA1c) Percent Levels at Week 28
|
-0.01 percent HbA1c
Interval -0.09 to 0.06
|
-0.06 percent HbA1c
Interval -0.13 to 0.01
|
SECONDARY outcome
Timeframe: Baseline, Week 28Population: FAS: All participants with CAH who were randomized into the study and who received at least 1 dose of study drug. Participants with evaluable data for the endpoint were analyzed for this outcome measure.
LS mean was assessed using ANCOVA. Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
Outcome measures
| Measure |
Chronocort
n=24 Participants
Participants received Chronocort at a starting dose of 30 mg, with dose adjustments down to 25, 20, or 15 mg based on adrenal insufficiency symptoms and androgen levels. Placebo was used for dose adjustment to maintain blinding.
|
Cortef
n=24 Participants
Participants received Cortef at a starting dose of 30 mg, with dose adjustments down to 25, 20, or 15 mg based on adrenal insufficiency symptoms and androgen levels. Placebo was used for dose adjustment to maintain blinding.
|
|---|---|---|
|
Change From Baseline in Waist Circumference at Week 28
|
0.867 centimeters
Interval -1.387 to 3.121
|
-1.242 centimeters
Interval -3.496 to 1.012
|
SECONDARY outcome
Timeframe: Baseline, Week 28Population: FAS: All participants with CAH who were randomized into the study and who received at least 1 dose of study drug. Participants with evaluable data for the endpoint were analyzed for this outcome measure.
LS mean was assessed by ANCOVA. Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
Outcome measures
| Measure |
Chronocort
n=25 Participants
Participants received Chronocort at a starting dose of 30 mg, with dose adjustments down to 25, 20, or 15 mg based on adrenal insufficiency symptoms and androgen levels. Placebo was used for dose adjustment to maintain blinding.
|
Cortef
n=25 Participants
Participants received Cortef at a starting dose of 30 mg, with dose adjustments down to 25, 20, or 15 mg based on adrenal insufficiency symptoms and androgen levels. Placebo was used for dose adjustment to maintain blinding.
|
|---|---|---|
|
Change From Baseline in Body Weight at Week 28
|
1.29 kilograms
Interval 0.0 to 2.58
|
-1.67 kilograms
Interval -2.96 to -0.38
|
SECONDARY outcome
Timeframe: Baseline, Week 28Population: FAS: All participants with CAH who were randomized into the study and who received at least 1 dose of study drug. Participants with evaluable data for the endpoint were analyzed for this outcome measure.
SF-36 evaluates aspects of functional health and well-being. The physical component has 4 sub-scales: physical function, role limitations due to physical problems, pain, and general health perception; and the mental component has 4 sub-scales: vitality, social function, role limitations due to emotional problems, and mental health. Total scores for the physical and mental component are presented as well as the sub-scale score for vitality. Scores were summarized and transformed into a range from 0 to 100; 0=worst, and 100=best outcome. Higher scores indicated better outcome. Change from baseline is reported (positive change from baseline indicated improvement). LS mean was assessed by ANCOVA. Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
Outcome measures
| Measure |
Chronocort
n=21 Participants
Participants received Chronocort at a starting dose of 30 mg, with dose adjustments down to 25, 20, or 15 mg based on adrenal insufficiency symptoms and androgen levels. Placebo was used for dose adjustment to maintain blinding.
|
Cortef
n=15 Participants
Participants received Cortef at a starting dose of 30 mg, with dose adjustments down to 25, 20, or 15 mg based on adrenal insufficiency symptoms and androgen levels. Placebo was used for dose adjustment to maintain blinding.
|
|---|---|---|
|
Change From Baseline Quality of Life Using the Self-completed Medical Outcome Study 36-Item Short Form Health Survey (SF-36) Total Score for the Physical and Mental Components and the Sub-domain of Vitality at Week 28
Physical Component
|
-3.313 score on a scale
Interval -5.801 to -0.824
|
-1.031 score on a scale
Interval -3.976 to 1.913
|
|
Change From Baseline Quality of Life Using the Self-completed Medical Outcome Study 36-Item Short Form Health Survey (SF-36) Total Score for the Physical and Mental Components and the Sub-domain of Vitality at Week 28
Mental Component
|
0.772 score on a scale
Interval -3.209 to 4.752
|
0.685 score on a scale
Interval -4.034 to 5.403
|
|
Change From Baseline Quality of Life Using the Self-completed Medical Outcome Study 36-Item Short Form Health Survey (SF-36) Total Score for the Physical and Mental Components and the Sub-domain of Vitality at Week 28
Vitality Sub-domain
|
-0.847 score on a scale
Interval -4.354 to 2.66
|
-0.002 score on a scale
Interval -4.157 to 4.153
|
Adverse Events
Cortef Run-In
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Chronocort
Serious events: 2 serious events
Other events: 22 other events
Deaths: 0 deaths
Cortef
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cortef Run-In
n=55 participants at risk
Participants received Cortef 30 mg total daily dose during the run-in therapy for 4 weeks prior to randomization.
|
Chronocort
n=25 participants at risk
Participants received Chronocort at a starting dose of 30 mg, with dose adjustments down to 25, 20, or 15 mg based on adrenal insufficiency symptoms and androgen levels. Placebo was used for dose adjustment to maintain blinding.
|
Cortef
n=28 participants at risk
Participants received Cortef at a starting dose of 30 mg, with dose adjustments down to 25, 20, or 15 mg based on adrenal insufficiency symptoms and androgen levels. Placebo was used for dose adjustment to maintain blinding.
|
|---|---|---|---|
|
Infections and infestations
COVID-19
|
0.00%
0/55 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
4.0%
1/25 • Number of events 1 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
0.00%
0/28 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/55 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
4.0%
1/25 • Number of events 1 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
0.00%
0/28 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/55 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
0.00%
0/25 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
3.6%
1/28 • Number of events 1 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
Other adverse events
| Measure |
Cortef Run-In
n=55 participants at risk
Participants received Cortef 30 mg total daily dose during the run-in therapy for 4 weeks prior to randomization.
|
Chronocort
n=25 participants at risk
Participants received Chronocort at a starting dose of 30 mg, with dose adjustments down to 25, 20, or 15 mg based on adrenal insufficiency symptoms and androgen levels. Placebo was used for dose adjustment to maintain blinding.
|
Cortef
n=28 participants at risk
Participants received Cortef at a starting dose of 30 mg, with dose adjustments down to 25, 20, or 15 mg based on adrenal insufficiency symptoms and androgen levels. Placebo was used for dose adjustment to maintain blinding.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/55 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
0.00%
0/25 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
7.1%
2/28 • Number of events 2 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/55 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
8.0%
2/25 • Number of events 2 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
7.1%
2/28 • Number of events 2 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
|
General disorders
Fatigue
|
0.00%
0/55 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
16.0%
4/25 • Number of events 6 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
17.9%
5/28 • Number of events 5 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
|
General disorders
Oedema peripheral
|
1.8%
1/55 • Number of events 1 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
4.0%
1/25 • Number of events 1 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
7.1%
2/28 • Number of events 2 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
|
General disorders
Pyrexia
|
0.00%
0/55 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
0.00%
0/25 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
21.4%
6/28 • Number of events 6 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
|
Infections and infestations
Ear infection
|
0.00%
0/55 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
8.0%
2/25 • Number of events 2 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
0.00%
0/28 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/55 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
8.0%
2/25 • Number of events 2 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
3.6%
1/28 • Number of events 1 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/55 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
8.0%
2/25 • Number of events 2 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
0.00%
0/28 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/55 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
8.0%
2/25 • Number of events 2 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
3.6%
1/28 • Number of events 1 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/55 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
4.0%
1/25 • Number of events 1 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
10.7%
3/28 • Number of events 4 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
|
Investigations
Weight increased
|
0.00%
0/55 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
12.0%
3/25 • Number of events 3 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
0.00%
0/28 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/55 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
12.0%
3/25 • Number of events 3 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
7.1%
2/28 • Number of events 2 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.8%
1/55 • Number of events 1 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
0.00%
0/25 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
7.1%
2/28 • Number of events 3 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/55 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
8.0%
2/25 • Number of events 2 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
3.6%
1/28 • Number of events 1 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
|
Nervous system disorders
Headache
|
0.00%
0/55 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
16.0%
4/25 • Number of events 4 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
10.7%
3/28 • Number of events 4 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
|
Psychiatric disorders
Stress
|
0.00%
0/55 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
8.0%
2/25 • Number of events 2 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
0.00%
0/28 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/55 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
8.0%
2/25 • Number of events 2 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
7.1%
2/28 • Number of events 2 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/55 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
4.0%
1/25 • Number of events 1 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
7.1%
2/28 • Number of events 2 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.8%
1/55 • Number of events 1 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
8.0%
2/25 • Number of events 2 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
7.1%
2/28 • Number of events 3 • Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef)
The Cortef Run-in reporting group was assessed using the screening population. The Cortef and Chronocort reporting groups were assessed using the safety analysis set that included all participants who were randomized and received at least 1 dose of study drug in the treatment period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place