Trial · NCT02716818

Comparison of Chronocort® With Standard Glucocorticoid Therapy in Patients With Congenital Adrenal Hyperplasia

NCT02716818, Phase 3, Completed, Neurocrine UK Limited; results first posted 2019-09-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Comparison of Chronocort® With Standard Glucocorticoid Therapy in Patients With Congenital Adrenal Hyperplasia. Trials, record NCT02716818. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02716818

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Comparison of Chronocort® With Standard Glucocorticoid Therapy in Patients With Congenital Adrenal Hyperplasia
NCT number: NCT02716818
Status: Completed
Phases: Phase 3
Enrollment: 122 participants, actual
Lead sponsor: Neurocrine UK Limited
Conditions: Congenital Adrenal Hyperplasia
Interventions: Chronocort®, standard glucocorticoid therapy
First posted: 2016-03-23
Last updated: 2026-10-02
Results first posted: 2019-09-04
Limitations and caveats: A limitation of the pre-defined primary endpoint was that it included an unsigned SDS score over a 24-hour period.

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline to 24 Weeks of the Mean of the 24-hour Standard Deviation Score (SDS) Profile for 17-OHP	24 weeks	Change from baseline to 24 weeks of the mean of the 24-hour standard deviation score (SDS) - also referred to as a z-score - profile for 17-OHP (17-Hydroxyprogesterone). The primary efficacy variable was the natural logarithm of the mean of the 24-hour SDS for the natural logarithm of 17-OHP. The mean of the 24-hour SDS profile for each visit was the arithmetic mean of all the SDSs with the first and last (13th) weighted one half relative to the intermediate SDSs. For each of the 13 log-transformed 17-OHP values at each visit, an SDS was calculated by counting the number of SDs that were above or below the mean of the log-transformed range. A negative z-score indicated greater control of 17-OHP when compared to baseline (0).
Secondary	Change From Baseline to 24 Weeks of the Mean of the 24-hour Standard Deviation Score (SDS) Profile for A4	24 weeks	Change from baseline to 24 weeks of the mean of the 24-hour standard deviation score (SDS) - also referred to as a z-score - profile for A4 (androstenedione). This secondary efficacy variable was calculated as follows: the natural logarithm of the mean of the 24-hour SDS for the natural logarithm of A4. The mean of the 24-hour SDS profile for each visit was the arithmetic mean of all the SDSs with the first and last (13th) weighted one half relative to the intermediate SDSs. For each of the 13 log-transformed A4 values at each visit, an SDS was calculated by counting the number of SDs that were above or below the mean of the log-transformed range. A negative z-score indicated greater control of A4 when compared to baseline (0).
Secondary	17-OHP and A4 by Individual Baseline Treatment Strata.	24 weeks	17-OHP and A4 by individual baseline treatment strata presented in the same manner as the primary endpoint (using 24-hour SDS profile at 24 weeks). Change from baseline to 24 weeks of the mean of the 24-hour standard deviation score (SDS) - also referred to as a z-score - profile for 17-OHP and A4. This secondary efficacy variable was calculated as follows: the natural logarithm of the mean of the 24-hour SDS for the natural logarithm of 17-OHP and A4. The mean of the 24-hour SDS profile for each visit was the arithmetic mean of all the SDSs with the first and last (13th) weighted one half relative to the intermediate SDSs. For each of the 13 log-transformed 17-OHP and A4 values at each visit, an SDS was calculated by counting the number of SDs that were above or below the mean of the log-transformed range. A negative z-score indicated greater control of 17-OHP and A4 when compared to baseline (0).
Secondary	Number of Participants With 17-OHP and A4 Levels in the Optimal Range at 9:00 at Week 24 Visit	24 weeks	17-OHP and A4 levels at 09:00 at the week 24 visit, as a responder analysis (i.e. the number of participants achieving results in the optimal range). Optimal range for 17-OHP (male) = 1.2\* - 6.7 nmol/L (female) = 1.2\* - 8.6 Optimal range for A4 (male) = 1.4 - 5.2 nmol/L (female) = 1.0 - 7.0 nmol/L \* = There is no lower reference range available for 17-OHP, hence the lower limit of the optimal range was used in the derivation of the average Standard Deviation Score. This enabled calculation of an 'unsigned' SDS score which was used to assess potential over-treatment as well as under-treatment.
Secondary	Changes Relative to Standard Glucocorticoid Therapy in Body Composition (DEXA - Fat Mass and Lean Mass)	Baseline and 24 weeks	Changes relative to Standard glucocorticoid therapy in body composition (DEXA) (fat mass and lean mass) - measured at all sites except Germany.
Secondary	Changes Relative to Standard Glucocorticoid Therapy in Body Composition (DEXA - Bone Mineral Density) - Measured at All Sites Except Germany.	Baseline and 24 weeks	Changes relative to Standard glucocorticoid therapy in body composition (DEXA - bone mineral density only) - measured at all sites except Germany.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline to 24 Weeks of the Mean of the 24-hour Standard Deviation Score (SDS) Profile for 17-OHP	24 weeks	The efficacy evaluable analysis set (EES) comprised all participants who were randomised into the study, who received at least one dose of Chronocort or standard GC therapy, and who had an evaluable Week 24 17-OHP 24-hour hormone profile, and who had no major protocol violations. Total sum of participants in the EES = 105.	Z-score	MEAN
SECONDARY	Change From Baseline to 24 Weeks of the Mean of the 24-hour Standard Deviation Score (SDS) Profile for A4	24 weeks	The efficacy evaluable analysis set (EES) comprised all participants who were randomised into the study, who received at least one dose of Chronocort or standard GC therapy, and who had an evaluable Week 24 17-OHP 24-hour hormone profile, and who had no major protocol violations. Total sum of participants in the EES = 105.	Z-score	MEAN
SECONDARY	17-OHP and A4 by Individual Baseline Treatment Strata.	24 weeks	The efficacy evaluable analysis set (EES) comprised all participants who were randomised into the study, who received at least one dose of Chronocort or standard GC therapy, and who had an evaluable Week 24 17-OHP 24-hour hormone profile, and who had no major protocol violations. Total sum of participants in the EES = 105.	Z-score	MEAN
SECONDARY	Number of Participants With 17-OHP and A4 Levels in the Optimal Range at 9:00 at Week 24 Visit	24 weeks	The efficacy evaluable analysis set (EES) comprised all participants who were randomised into the study, who received at least one dose of Chronocort or standard GC therapy, and who had an evaluable Week 24 17-OHP 24-hour hormone profile, and who had no major protocol violations. Total sum of participants in the EES = 105.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Changes Relative to Standard Glucocorticoid Therapy in Body Composition (DEXA - Fat Mass and Lean Mass)	Baseline and 24 weeks	The efficacy evaluable analysis set (EES) comprised all participants who were randomised into the study, who received at least one dose of Chronocort or standard GC therapy, and who had an evaluable Week 24 17-OHP 24-hour hormone profile, and who had no major protocol violations. German subjects were excluded from this analysis subset.	kilograms	MEAN
SECONDARY	Changes Relative to Standard Glucocorticoid Therapy in Body Composition (DEXA - Bone Mineral Density) - Measured at All Sites Except Germany.	Baseline and 24 weeks	The efficacy evaluable analysis set (EES) comprised all participants who were randomised into the study, who received at least one dose of Chronocort or standard GC therapy, and who had an evaluable Week 24 17-OHP 24-hour hormone profile, and who had no major protocol violations. German subjects were excluded from this analysis subset.	g/cm^2	MEAN

Source ClinicalTrials.gov

Results by group26

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline to 24 Weeks of the Mean of the 24-hour Standard Deviation Score (SDS) Profile for 17-OHP	Chronocort®	-0.403	Standard Deviation 0.8499	Z-score
Change From Baseline to 24 Weeks of the Mean of the 24-hour Standard Deviation Score (SDS) Profile for 17-OHP	Standard Glucocorticoid Therapy	-0.172	Standard Deviation 0.7776	Z-score
Change From Baseline to 24 Weeks of the Mean of the 24-hour Standard Deviation Score (SDS) Profile for A4	Chronocort®	0.113	Standard Deviation 0.9221	Z-score
Change From Baseline to 24 Weeks of the Mean of the 24-hour Standard Deviation Score (SDS) Profile for A4	Standard Glucocorticoid Therapy	-0.041	Standard Deviation 0.7731	Z-score
17-OHP and A4 by Individual Baseline Treatment Strata.	Pre-Baseline - Hydrocortisone - 17-OHP	-0.248	Standard Deviation 0.7661	Z-score
17-OHP and A4 by Individual Baseline Treatment Strata.	Pre-Baseline - Prednisone/Prednisolone - 17-OHP	-0.061	Standard Deviation 0.8051	Z-score
17-OHP and A4 by Individual Baseline Treatment Strata.	Pre-Baseline - Dexamethasone - 17-OHP	-0.245	Standard Deviation 0.8522	Z-score
17-OHP and A4 by Individual Baseline Treatment Strata.	Pre-Baseline - Chronocort vs. Hydrocortisone - 17-OHP	-0.431	Standard Deviation 0.8727	Z-score
17-OHP and A4 by Individual Baseline Treatment Strata.	Pre-Baseline - Chronocort vs. Prednisone/Prednisolone - 17-OHP	-0.320	Standard Deviation 0.7627	Z-score
17-OHP and A4 by Individual Baseline Treatment Strata.	Pre-Baseline - Chronocort vs. Dexamethasone - 17-OHP	-0.565	Standard Deviation 1.2343	Z-score

1 to 10 of 26Source ClinicalTrials.gov

See all 26 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Chronocort®	61
Overall Study	STARTED	Standard Glucocorticoid Therapy	61
Overall Study	COMPLETED	Chronocort®	58
Overall Study	COMPLETED	Standard Glucocorticoid Therapy	59
Overall Study	NOT COMPLETED	Chronocort®	3
Overall Study	NOT COMPLETED	Standard Glucocorticoid Therapy	2

Source ClinicalTrials.gov

Adverse events374

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Acute Sinusitis	Infections and infestations	Chronocort®	1	61	1
other	Acute Sinusitis	Infections and infestations	Standard Glucocorticoid Therapy	0	61	0
other	Bronchitis	Infections and infestations	Chronocort®	1	61	1
other	Bronchitis	Infections and infestations	Standard Glucocorticoid Therapy	0	61	0
other	Conjunctivitis viral	Infections and infestations	Chronocort®	1	61	1
other	Conjunctivitis viral	Infections and infestations	Standard Glucocorticoid Therapy	0	61	0
other	Cystitis	Infections and infestations	Chronocort®	1	61	1
other	Cystitis	Infections and infestations	Standard Glucocorticoid Therapy	0	61	0
other	Ear infection fungal	Infections and infestations	Chronocort®	1	61	1
other	Ear infection fungal	Infections and infestations	Standard Glucocorticoid Therapy	0	61	0

1 to 10 of 374Source ClinicalTrials.gov

See all 374 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Chronocort®	0	61
Total, all-cause mortality	Standard Glucocorticoid Therapy	0	61
Total, other adverse events	Chronocort®	59	61
Total, other adverse events	Standard Glucocorticoid Therapy	48	61
Total, serious adverse events	Chronocort®	7	61
Total, serious adverse events	Standard Glucocorticoid Therapy	5	61

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33527139	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Chronocort® vs Standard Glucocorticoid Therapy: deaths from any cause	Trial comparisons
Chronocort® vs Standard Glucocorticoid Therapy: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02716818

GET https://conductscience.org/api/trials/v1/NCT02716818/results?page=2

API reference For AI assistants