ClinicalTrials.gg
CompletedNCT01735617Updated Oct 2, 2026Results posted

Pilot Study to Characterize and Examine the Pharmacokinetics and Efficacy of Chronocort® in Adults With CAH

A Phase 2 interventional study of Hydrocortisone Modified Release Capsules in Endocrine Disease, Adrenal Insufficiency and Congenital Adrenal Hyperplasia, sponsored by Neurocrine UK Limited. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.

Sponsored by Neurocrine UK Limited (formerly part of Neurocrine Biosciences) · Phase 2, Interventional, and Treatment

Updated Oct 2, 2026Posted results revisedGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to gather safety and effectiveness information about a new formulation of Hydrocortisone (Chronocort®) used to treat patients with a disease called congenital adrenal hyperplasia (CAH). Hydrocortisone is the man-made version of the hormone cortisol, which is released in the body following a regular daily pattern. The objective of the study is to measure the levels of hydrocortisone that are absorbed into the bloodstream once Chronocort® is taken and what affects it has on other hormones in the body. Since Chronocort® is anticipated to mimic the same release pattern of cortisol in the body, it is hoped that patients with CAH will be treated more effectively to manage their disease.

Read the detailed description

This study is a Phase 2 pilot study to characterize and examine the pharmacokinetics and efficacy profile of Chronocort® in adults with congenital adrenal hyperplasia (CAH). It is designed as a two-part, single cohort, open label, multiple dose Phase 2 pilot study to: (Part A) characterize and examine the pharmacokinetics (PK) and disease bio-marker behavior following short-term dosing with Chronocort®; and to (Part B) examine the disease control after six months dose titration with Chronocort® in adults with CAH.

02

Conditions studied

  • Endocrine Disease
  • Adrenal Insufficiency
  • Congenital Adrenal Hyperplasia

Keywords

  • congenital adrenal hyperplasia
  • glucocorticoids
  • cortisol
  • adrenal
03

In context

Endocrine System Diseases

322 studies on the registry are indexed under Endocrine System Diseases; 51 are open to participants now.

This study's enrollment of 16 is below the median of 69 across 221 interventional studies indexed under Endocrine System Diseases.

Browse Endocrine System Diseases studies →

Lead sponsor

Neurocrine UK Limited is the lead sponsor of 18 studies on the registry; none are open to participants now.

First submitted before Neurocrine UK Limited left Neurocrine Biosciences.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Known CAH due to 21-hydroxylase deficiency (classic CAH) based on hormonal and genetic testing currently treated with hydrocortisone, prednisone, prednisolone or dexamethasone on a stable dosage for a minimum of 3 months.
  2. Male or female patients aged 18 and above.
  3. Provision of signed written .
  4. Good general health.
  5. Females of must have a negative pregnancy test initially and at all visits. Females who are engaging in sexual intercourse must be using a medically acceptable method of (as defined in the protocol, section 10.5).
  6. Plasma renin activity must be within the clinically acceptable range at screening (less than 1.5 times upper normal range).

Exclusion criteria

Exclusion Criteria:

  1. Co-morbid condition requiring daily administration of a medication that induces hepatic enzymes or interferes with the metabolism of .
  2. Clinical or biochemical evidence of hepatic or renal disease. Creatinine above the normal range or elevated liver function tests ( or AST) > 2 times the .
  3. Females who are pregnant or lactating.
  4. Women taking an estrogen-containing oral pill and who have taken it within 6 weeks of recruitment.
  5. Patients taking spironolactone.
  6. Patients on inhaled or oral steroids apart from treatment for CAH.
  7. Patients with any other significant medical or psychiatric conditions that in the opinion of the Investigator would preclude participation in the trial.
  8. Participation in another clinical trial of an or licensed drug or device within the 3 months prior to inclusion in this study.
  9. Patients with history of bilateral adrenalectomy.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Hydrocortisone Modified Release Capsules

    Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response

    Drug: Hydrocortisone Modified Release Capsules

Interventions

  • Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment

    Also known as: Chronocort

06

What researchers measure

Primary outcomes

  1. Pharmacokinetic Profile (Cmax) Following Short-term Treatment With Chronocort® in Adult Patients With Congenital Adrenal Hyperplasia

    The maximum plasma concentration (Cmax) of chronocort

    Time frame: 24 hours

  2. Pharmacokinetic Profile (AUC0-24) Following Short-term Treatment With Chronocort® in Adult Patients With Congenital Adrenal Hyperplasia

    Area under the curve (AUC) from 0 to 24 hours (sampling occurs at the following timepoints: 2300, 0100, 0300, 0500, 0600, 0700, 0800, 0900, 1000, 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1900, 2100, 2300hrs)

    Time frame: 24 hours (at 2300, 0100, 0300, 0500, 0600, 0700, 0800, 0900, 1000, 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1900, 2100, 2300hrs)

  3. Pharmacokinetic Profile (Tmax) Following Short-term Treatment With Chronocort® in Adult Patients With Congenital Adrenal Hyperplasia

    Time to maximum plasma concentration (tmax)

    Time frame: 24 hours

Secondary outcomes

  1. The Percentage of Patients With 17-OHP and Androstenedione Levels at 0700h Within Proposed Optimal Ranges Whilst on Chronocort and Whilst on Standard Therapy (at Baseline)

    Proposed optimal ranges of 17-OHP: 300-1200ng/dl Proposed optimal ranges of androstenedione: 40-150ng.dl for males and 30-200ng/dl for females

    Time frame: Specific time point (0700hrs)

  2. 17-OHP Levels at 0700h, 1700h and 2300h

    17-OHP levels at 0700h, 1700h and 2300h

    Time frame: Specified time points (0700h, 1700h and 2300h)

  3. Androstenedione Levels at 0700h, 1700h and 2300h

    Androstenedione levels at 0700h, 1700h and 2300h

    Time frame: Specified time points (0700h, 1700h and 2300h)

  4. ACTH Levels at 0700h, 1700h and 2300h

    ACTH levels at 0700h, 1700h and 2300h

    Time frame: Specified time points (0700h, 1700h and 2300h)

  5. AUC Values (Nmol*h/L) for Androstenedione

    AUC values (nmol\*h/L) for Androstenedione for the following reporting periods: 24 hours (2300-2300h), 2300-0700h, 0700-1500h and 1500-2300h

    Time frame: Specific time points (2300-2300h, 2300-0700h, 0700-1500h and 1500-2300h)

  6. AUC Values (Nmol*h/L) for 17-OHP

    AUC values (nmol\*h/L) for 17-OHP for the following reporting periods: 24 hours (2300-2300h), 2300-0700h, 0700-1500h and 1500-2300h

    Time frame: Specific time points (2300-2300h, 2300-0700h, 0700-1500h and 1500-2300h)

  7. AUC Values (Pmol*h/L) for ACTH

    AUC values (pmol\*h/L) for ACTH for the following reporting periods: 24 hours (2300-2300h), 2300-0700h, 0700-1500h and 1500-2300h

    Time frame: Specific time points (2300-2300h, 2300-0700h, 0700-1500h and 1500-2300h)

07

Results

Posted May 17, 2017

Participant flow

Participant flow — Overall Study
MilestoneHydrocortisone Modified Release Capsules
Started16
Completed16
Not completed0

Outcome measures

PrimaryPharmacokinetic Profile (Cmax) Following Short-term Treatment With Chronocort® in Adult Patients With Congenital Adrenal Hyperplasia

The maximum plasma concentration (Cmax) of chronocort

Time frame:
24 hours
Reported as:
Mean · nmol/L
Pharmacokinetic Profile (Cmax) Following Short-term Treatment With Chronocort® in Adult Patients With Congenital Adrenal Hyperplasia
nmol/LChronocort
Pharmacokinetic Profile (Cmax) Following Short-term Treatment With Chronocort® in Adult Patients With Congenital Adrenal Hyperplasia601.213 ± 114.5987
Statistical analysis
  • Chronocort · Geometric means: 563.38
PrimaryPharmacokinetic Profile (AUC0-24) Following Short-term Treatment With Chronocort® in Adult Patients With Congenital Adrenal Hyperplasia

Area under the curve (AUC) from 0 to 24 hours (sampling occurs at the following timepoints: 2300, 0100, 0300, 0500, 0600, 0700, 0800, 0900, 1000, 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1900, 2100, 2300hrs)

Time frame:
24 hours (at 2300, 0100, 0300, 0500, 0600, 0700, 0800, 0900, 1000, 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1900, 2100, 2300hrs)
Reported as:
Mean · h*nmol/L
Pharmacokinetic Profile (AUC0-24) Following Short-term Treatment With Chronocort® in Adult Patients With Congenital Adrenal Hyperplasia
h*nmol/LChroncort
Pharmacokinetic Profile (AUC0-24) Following Short-term Treatment With Chronocort® in Adult Patients With Congenital Adrenal Hyperplasia5027.641 ± 1247.8425
PrimaryPharmacokinetic Profile (Tmax) Following Short-term Treatment With Chronocort® in Adult Patients With Congenital Adrenal Hyperplasia

Time to maximum plasma concentration (tmax)

Time frame:
24 hours
Reported as:
Mean · Hours
Pharmacokinetic Profile (Tmax) Following Short-term Treatment With Chronocort® in Adult Patients With Congenital Adrenal Hyperplasia
HoursChronocort
Pharmacokinetic Profile (Tmax) Following Short-term Treatment With Chronocort® in Adult Patients With Congenital Adrenal Hyperplasia7.9 ± 2.9
SecondaryThe Percentage of Patients With 17-OHP and Androstenedione Levels at 0700h Within Proposed Optimal Ranges Whilst on Chronocort and Whilst on Standard Therapy (at Baseline)

Proposed optimal ranges of 17-OHP: 300-1200ng/dl Proposed optimal ranges of androstenedione: 40-150ng.dl for males and 30-200ng/dl for females

Time frame:
Specific time point (0700hrs)
Reported as:
Number · percentage of participants
The Percentage of Patients With 17-OHP and Androstenedione Levels at 0700h Within Proposed Optimal Ranges Whilst on Chronocort and Whilst on Standard Therapy (at Baseline)
percentage of participantsHydrocortisone Modified Release Capsules
17-OHP (baseline)0
17-OHP (final visit)12.5
Androstenedione (baseline)56.3
Androstenedione (final visit)81.3
Secondary17-OHP Levels at 0700h, 1700h and 2300h

17-OHP levels at 0700h, 1700h and 2300h

Time frame:
Specified time points (0700h, 1700h and 2300h)
Reported as:
Mean · nmol/L
17-OHP Levels at 0700h, 1700h and 2300h
nmol/LHydrocortisone Modified Release Capsules
17-OHP: Part A, Days 1-2 (0700h)76.97 ± 91.986
17-OHP: Part A, Days 1-2 (1700h)70.99 ± 104.106
17-OHP: Part A, Days 1-2 (2300h)55.35 ± 93.632
17-OHP: Part A, Days 4-5 (0700h)7.72 ± 8.231
17-OHP: Part A, Days 4-5 (1700h)23.55 ± 66.046
17-OHP: Part A, Days 4-5 (2300h)27.27 ± 55.140
17-OHP: Part B, Visit 2 (0700h)24.86 ± 54.086
17-OHP: Part B, Visit 2 (1700h)15.17 ± 20.400
17-OHP: Part B, Visit 2 (2300h)26.65 ± 51.185
17-OHP: Part B, Visit 3 (0700h)34.87 ± 49.072
17-OHP: Part B, Visit 3 (1700h)13.81 ± 20.700
17-OHP: Part B, Visit 3 (2300h)18.95 ± 28.276
17-OHP: Part B, Visit 4 (0700h)13.67 ± 19.091
17-OHP: Part B, Visit 4 (1700h)34.70 ± 69.876
17-OHP: Part B, Visit 4 (2300h)22.19 ± 46.826
SecondaryAndrostenedione Levels at 0700h, 1700h and 2300h

Androstenedione levels at 0700h, 1700h and 2300h

Time frame:
Specified time points (0700h, 1700h and 2300h)
Reported as:
Mean · nmol/L
Androstenedione Levels at 0700h, 1700h and 2300h
nmol/LHydrocortisone Modified Release Capsules
Androstenedione: Part A, Days 1-2 (0700h)7.92 ± 8.474
Androstenedione: Part A, Days 1-2 (1700h)7.54 ± 7.966
Androstenedione: Part A, Days 1-2 (2300h)7.43 ± 9.388
Androstenedione: Part A, Days 4-5 (0700h)3.11 ± 2.178
Androstenedione: Part A, Days 4-5 (1700h)4.62 ± 8.005
Androstenedione: Part A, Days 4-5 (2300h)5.37 ± 8.340
Androstenedione: Part B, Visit 2 (0700h)4.96 ± 6.731
Androstenedione: Part B, Visit 2 (1700h)3.47 ± 3.094
Androstenedione: Part B, Visit 2 (2300h)3.79 ± 3.748
Androstenedione: Part B, Visit 3 (0700h)4.57 ± 3.561
Androstenedione: Part B, Visit 3 (1700h)3.61 ± 2.713
Androstenedione: Part B, Visit 3 (2300h)3.91 ± 3.103
Androstenedione: Part B, Visit 4 (0700h)3.40 ± 1.973
Androstenedione: Part B, Visit 4 (1700h)4.19 ± 4.602
Androstenedione: Part B, Visit 4 (2300h)3.37 ± 2.655
SecondaryACTH Levels at 0700h, 1700h and 2300h

ACTH levels at 0700h, 1700h and 2300h

Time frame:
Specified time points (0700h, 1700h and 2300h)
Reported as:
Mean · pmol/L
ACTH Levels at 0700h, 1700h and 2300h
pmol/LHydrocortisone Modified Release Capsules
ACTH: Part A, Days 1-2 (0700h)21.06 ± 29.767
ACTH: Part A, Days 1-2 (1700h)20.93 ± 30.121
ACTH: Part A, Days 1-2 (2300h)7.75 ± 9.873
ACTH: Part A, Days 4-5 (0700h)4.16 ± 9.190
ACTH: Part A, Days 4-5 (1700h)4.71 ± 7.382
ACTH: Part A, Days 4-5 (2300h)7.37 ± 7.990
ACTH: Part B, Visit 2 (0700h)7.02 ± 12.159
ACTH: Part B, Visit 2 (1700h)5.57 ± 6.769
ACTH: Part B, Visit 2 (2300h)8.66 ± 14.637
ACTH: Part B, Visit 3 (0700h)9.66 ± 12.418
ACTH: Part B, Visit 3 (1700h)4.71 ± 6.331
ACTH: Part B, Visit 3 (2300h)6.04 ± 7.997
ACTH: Part B, Visit 4 (0700h)12.18 ± 29.911
ACTH: Part B, Visit 4 (1700h)13.66 ± 22.851
ACTH: Part B, Visit 4 (2300h)9.44 ± 17.474
SecondaryAUC Values (Nmol*h/L) for Androstenedione

AUC values (nmol\*h/L) for Androstenedione for the following reporting periods: 24 hours (2300-2300h), 2300-0700h, 0700-1500h and 1500-2300h

Time frame:
Specific time points (2300-2300h, 2300-0700h, 0700-1500h and 1500-2300h)
Reported as:
Mean · nmol*h/L
AUC Values (Nmol*h/L) for Androstenedione
nmol*h/LHydrocortisone Modified Release Capsules
Androstenedione: Part A, Days 1-2 AUC (2300-2300h)166.19 ± 171.969
Androstenedione: Part A, Days 1-2 AUC (2300-0700h)41.42 ± 34.133
Androstenedione: Part A, Days 1-2 AUC (0700-1500h)65.33 ± 76.337
Androstenedione: Part A, Days 1-2 AUC (1500-2300h)59.44 ± 65.995
Androstenedione: Part A, Days 4-5 AUC (2300-2300h)104.37 ± 128.725
Androstenedione: Part A, Days 4-5 AUC (2300-0700h)36.02 ± 40.225
Androstenedione: Part A, Days 4-5 AUC (0700-1500h)32.01 ± 31.503
Androstenedione: Part A, Days 4-5 AUC (1500-2300h)37.91 ± 58.394
Androstenedione: Part B, Visit 2 AUC (2300-2300h)88.58 ± 86.364
Androstenedione: Part B, Visit 2 AUC (2300-0700h)35.12 ± 43.580
Androstenedione: Part B, Visit 2 AUC (0700-1500h)26.07 ± 22.298
Androstenedione: Part B, Visit 2 AUC (1500-2300h)27.39 ± 23.989
Androstenedione: Part B, Visit 3 AUC (2300-2300h)91.46 ± 65.295
Androstenedione: Part B, Visit 3 AUC (2300-0700h)33.25 ± 26.255
Androstenedione: Part B, Visit 3 AUC (0700-1500h)27.92 ± 16.297
Androstenedione: Part B, Visit 3 AUC (1500-2300h)30.30 ± 26.188
Androstenedione: Part B, Visit 4 AUC (2300-2300h)86.27 ± 70.892
Androstenedione: Part B, Visit 4 AUC (2300-0700h)29.09 ± 23.314
Androstenedione: Part B, Visit 4 AUC (0700-1500h)27.03 ± 20.009
Androstenedione: Part B, Visit 4 AUC (1500-2300h)30.13 ± 28.797
SecondaryAUC Values (Nmol*h/L) for 17-OHP

AUC values (nmol\*h/L) for 17-OHP for the following reporting periods: 24 hours (2300-2300h), 2300-0700h, 0700-1500h and 1500-2300h

Time frame:
Specific time points (2300-2300h, 2300-0700h, 0700-1500h and 1500-2300h)
Reported as:
Mean · nmol*h/L
AUC Values (Nmol*h/L) for 17-OHP
nmol*h/LHydrocortisone Modified Release Capsules
17-OHP: Part A, Days 1-2 AUC 2300-2300h1407.83 ± 1829.291
17-OHP: Part A, Days 1-2 AUC 2300-0700h243.99 ± 339.580
17-OHP: Part A, Days 1-2 AUC 0700-1500h607.74 ± 805.822
17-OHP: Part A, Days 1-2 AUC 1500-2300h556.11 ± 769.492
17-OHP: Part A, Days 4-5 AUC 2300-2300h446.90 ± 817.074
17-OHP: Part A, Days 4-5 AUC 2300-0700h169.83 ± 268.178
17-OHP: Part A, Days 4-5 AUC 0700-1500h91.53 ± 147.801
17-OHP: Part A, Days 4-5 AUC 1500-2300h190.73 ± 425.505
17-OHP: Part B, Visit 2 AUC 2300-2300h395.65 ± 587.533
17-OHP: Part B, Visit 2 AUC 2300-0700h168.01 ± 337.666
17-OHP: Part B, Visit 2 AUC 0700-1500h82.41 ± 91.708
17-OHP: Part B, Visit 2 AUC 1500-2300h145.24 ± 215.115
17-OHP: Part B, Visit 3 AUC 2300-2300h432.02 ± 393.897
17-OHP: Part B, Visit 3 AUC 2300-0700h152.63 ± 144.576
17-OHP: Part B, Visit 3 AUC 0700-1500h139.21 ± 147.353
17-OHP: Part B, Visit 3 AUC 1500-2300h140.18 ± 182.786
17-OHP: Part B, Visit 4 AUC 2300-2300h436.54 ± 678.052
17-OHP: Part B, Visit 4 AUC 2300-0700h101.33 ± 148.003
17-OHP: Part B, Visit 4 AUC 0700-1500h120.32 ± 172.134
17-OHP: Part B, Visit 4 AUC 1500-2300h214.89 ± 364.641
SecondaryAUC Values (Pmol*h/L) for ACTH

AUC values (pmol\*h/L) for ACTH for the following reporting periods: 24 hours (2300-2300h), 2300-0700h, 0700-1500h and 1500-2300h

Time frame:
Specific time points (2300-2300h, 2300-0700h, 0700-1500h and 1500-2300h)
Reported as:
Mean · pmol*h/L
AUC Values (Pmol*h/L) for ACTH
pmol*h/LHydrocortisone Modified Release Capsules
ACTH: Part A, Days 1-2 AUC (2300-2300h)356.25 ± 415.949
ACTH: Part A, Days 1-2 AUC (2300-0700h)54.72 ± 70.267
ACTH: Part A, Days 1-2 AUC (0700-1500h)166.18 ± 206.294
ACTH: Part A, Days 1-2 AUC (1500-2300h)135.35 ± 169.002
ACTH: Part A, Days 4-5 AUC (2300-2300h)120.00 ± 121.454
ACTH: Part A, Days 4-5 AUC (2300-0700h)52.22 ± 62.067
ACTH: Part A, Days 4-5 AUC (0700-1500h)21.29 ± 19.824
ACTH: Part A, Days 4-5 AUC (1500-2300h)47.13 ± 57.145
ACTH: Part B, Visit 2 AUC (2300-2300h)125.45 ± 118.081
ACTH: Part B, Visit 2 AUC (2300-0700h)43.09 ± 46.711
ACTH: Part B, Visit 2 AUC (0700-1500h)34.14 ± 48.423
ACTH: Part B, Visit 2 AUC (1500-2300h)48.22 ± 49.078
ACTH: Part B, Visit 3 AUC (2300-2300h)154.10 ± 172.474
ACTH: Part B, Visit 3 AUC (2300-0700h)50.02 ± 57.268
ACTH: Part B, Visit 3 AUC (0700-1500h)52.46 ± 64.571
ACTH: Part B, Visit 3 AUC (1500-2300h)51.63 ± 70.735
ACTH: Part B, Visit 4 AUC (2300-2300h)252.30 ± 420.220
ACTH: Part B, Visit 4 AUC (2300-0700h)58.80 ± 107.955
ACTH: Part B, Visit 4 AUC (0700-1500h)110.58 ± 329.386
ACTH: Part B, Visit 4 AUC (1500-2300h)82.92 ± 120.287

Adverse events

Collected over Approximately 7 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Hydrocortisone Modified Release Capsules—0/16 (0%)16/16 (100%)
Most frequent other events
Showing 10 of 11
Most frequent other events
EventHydrocortisone Modified Release Capsules
HeadacheNervous system disorders13/16
FatigueGeneral disorders13/16
DizzinessNervous system disorders8/16
AnaemiaBlood and lymphatic system disorders7/16
Weight increaseInvestigations7/16
Appetite decreaseMetabolism and nutrition disorders7/16
Appetite increaseMetabolism and nutrition disorders6/16
ArthralgiaMusculoskeletal and connective tissue disorders5/16
InsomniaPsychiatric disorders5/16
AcneSkin and subcutaneous tissue disorders5/16

Baseline characteristics

All treated subjects

Age, Continuous
Age, Continuous(years)Hydrocortisone Modified Release Capsules
Mean28.7 ± 12.97
Sex: Female, Male
Sex: Female, Male(Participants)Hydrocortisone Modified Release Capsules
Female8
Male8
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Hydrocortisone Modified Release Capsules
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American1
White13
More than one race1
Unknown or Not Reported1
Region of Enrollment
Region of Enrollment(participants)Hydrocortisone Modified Release Capsules
United States16
08

Study locations

1 site
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892-1932, United States
09

References and documents

Publications

  • Mallappa A, Sinaii N, Kumar P, Whitaker MJ, Daley LA, Digweed D, Eckland DJ, Van Ryzin C, Nieman LK, Arlt W, Ross RJ, Merke DP. A phase 2 study of Chronocort, a modified-release formulation of hydrocortisone, in the treatment of adults with classic congenital adrenal hyperplasia. J Clin Endocrinol Metab. 2015 Mar;100(3):1137-45. doi: 10.1210/jc.2014-3809. Epub 2014 Dec 11. PubMed 25494662 ↗

Individual participant data

Plan to share: No

10

Timeline

1 registry update since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2012, a primary completion of Dec 2013 and a completion of Dec 2013. It does not say whether these dates are actual or estimated.

Results were first posted in May 2017, 3 years 5 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 20, 2012
First posted
Nov 28, 2012
Start
Dec 2012
Primary completionActual
Dec 2013
CompletionActual
Dec 2013
Results first posted
May 17, 2017
Last update
Oct 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Results
Posted results revised
revised Oct 2, 2026
Show all 1 update
  1. Oct 2, 2026
    Posted results revised
    + 2 other changes: verification date and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT01735617
Responsible party
Sponsor
First posted
Nov 28, 2012
Start date
Dec 2012
Primary completion
Dec 2013
Completion
Dec 2013
Results posted
May 17, 2017
Last update
Oct 2, 2026

Study contacts

Deborah P Merke, BS, MS, MD
principal investigator · National Institutes of Health Clinical Center (CC)

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Hydrocortisone

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