Trial · NCT03062280
A Study of the Efficacy, Safety and Tolerability of Chronocort in Treating CAH
NCT03062280, Phase 3, Completed, Neurocrine UK Limited; results first posted 2024-10-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of the Efficacy, Safety and Tolerability of Chronocort in Treating CAH. Trials, record NCT03062280. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03062280
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of the Efficacy, Safety and Tolerability of Chronocort in Treating CAH
- NCT number
- NCT03062280
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 91 participants, actual
- Lead sponsor
- Neurocrine UK Limited
- Conditions
- Congenital Adrenal Hyperplasia
- Interventions
- Hydrocortisone
- First posted
- 2017-02-23
- Last updated
- 2026-10-02
- Results first posted
- 2024-10-24
Source ClinicalTrials.gov
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety and Tolerability - Number of Participants With Adrenal Insufficiency | Up to approximately 5 years and 11 months | Safety and tolerability of Chronocort® over time, as assessed by signs and symptoms of adrenal insufficiency or over-treatment throughout the study. Signs and symptoms of adrenal insufficiency included sudden weight loss, sudden weight gain, lack of appetite, increased appetite, nausea, vomiting, headache, blurred vision, fatigue, weakness, dizziness, light-headedness, syncope, sleeping difficulties and increased acne. Number of participants who experienced adrenal insufficiency due to glucocorticoid (GC) over replacement and under replacement are reported. |
| Primary | Safety and Tolerability - Number of Participants Who Used Sick Day Medication | Up to approximately 5 years and 11 months | Safety and tolerability of Chronocort, as assessed by number of participants who used sick day medication throughout the study. Data are presented for number of participants taking medication from sick day packs and number of participants taking medication that was not from sick day packs. |
| Primary | Safety and Tolerability - Number of Participants Who Experienced at Least One Adrenal Crisis | Up to approximately 5 years and 11 months | Safety and tolerability of Chronocort, as assessed by the number of participants who experienced adrenal crises throughout the study. Adrenal crisis was defined as follows: a) Major impairment of general health with at least two of the following signs/symptoms: Hypotension (systolic blood pressure \<100 mmHg); Nausea or vomiting; Severe fatigue; Fever; Somnolence; Hyponatraemia (\<132 mmol/L) or hyperkalaemia (as judged by characteristic electrocardiogram \[ECG\] changes); Hypoglycaemia and b) Parenteral glucocorticoid (hydrocortisone) administration followed by clinical improvement: Grade 1: outpatient care only; Grade 2: hospital care (general ward); Grade 3: admission to intensive care unit; Grade 4: death from adrenal crisis (with or without parenteral glucocorticoid administration). |
| Primary | Safety and Tolerability - Number of Participants With Adverse Events (AEs) | Up to approximately 5 years and 11 months | Safety and tolerability of Chronocort, as assessed by the number of participants with at least 1 AE per specified AE category throughout the study. An AE was any untoward medical occurrence in a participant administered the study drug that did not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, was a congenital anomaly or birth defect, was infection that required treatment parenteral antibiotics, other important medical events which based on medical or scientific judgement might jeopardize the participants, or might require medical or surgical intervention to prevent any of the above. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section. |
| Primary | Safety Laboratory Assessments - Number of Participants With a Shift in Laboratory Parameters Baseline Values to the Maximum Values | Baseline up to approximately 5 years and 11 months | Safety and tolerability of Chronocort, as assessed by change from pre-Chronocort baseline in safety laboratory assessments throughout the study. Participants with a parameter value that shifted from baseline (within reference range) to a value above the reference range for a maximum value on-treatment. |
| Primary | Safety Laboratory Assessments - Number of Participants With a Shift in Laboratory Parameters Baseline Values to the Minimum Values | Baseline up to approximately 5 years and 11 months | Safety and tolerability of Chronocort, as assessed by change from pre-Chronocort baseline in safety laboratory assessments throughout the study. Participants with a parameter value that shifted from baseline (within reference range) to a value below the reference range for a minimum value on-treatment. |
| Primary | Safety and Tolerability - Change From Pre-Chronocort Baseline to Month 30 in Vital Signs - Diastolic Blood Pressure | Baseline, Month 30 | Long-term safety and tolerability of Chronocort, as assessed by change from pre-Chronocort baseline to Month 30 in vital signs - Diastolic blood pressure. |
| Primary | Safety and Tolerability - Change From Pre-Chronocort Baseline to Month 30 in Vital Signs - Systolic Blood Pressure | Baseline, Month 30 | Long-term safety and tolerability of Chronocort, as assessed by change from pre-Chronocort baseline to Month 30 in vital signs - Systolic blood pressure. |
| Primary | Safety and Tolerability - Change From Pre-Chronocort Baseline to Month 30 in Vital Signs - Pulse Rate | Baseline, Month 30 | Long-term safety and tolerability of Chronocort, as assessed by change from pre-Chronocort baseline to Month 30 in vital signs - Pulse rate. |
| Primary | Safety and Tolerability - Change From Pre-Chronocort Baseline to Month 30 in Vital Signs - Respiratory Rate | Baseline, Month 30 | Long-term safety and tolerability of Chronocort, as assessed by change from pre-Chronocort baseline to Month 30 in vital signs - Respiratory rate. |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 registered outcomesOutcomes33
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Safety and Tolerability - Number of Participants With Adrenal Insufficiency | Up to approximately 5 years and 11 months | The Full Analysis Set included all participants who entered the extension study and who subsequently received at least 1 dose of Chronocort. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Safety and Tolerability - Number of Participants Who Used Sick Day Medication | Up to approximately 5 years and 11 months | The Full Analysis Set included all participants who entered the extension study and who subsequently received at least 1 dose of Chronocort. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Safety and Tolerability - Number of Participants Who Experienced at Least One Adrenal Crisis | Up to approximately 5 years and 11 months | The Full Analysis Set included all participants who entered the extension study and who subsequently received at least 1 dose of Chronocort. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Safety and Tolerability - Number of Participants With Adverse Events (AEs) | Up to approximately 5 years and 11 months | The Full Analysis Set included all participants who entered the extension study and who subsequently received at least 1 dose of Chronocort. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Safety Laboratory Assessments - Number of Participants With a Shift in Laboratory Parameters Baseline Values to the Maximum Values | Baseline up to approximately 5 years and 11 months | The Full Analysis Set included all participants who entered the extension study and who subsequently received at least 1 dose of Chronocort. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. Number analyzed for each parameter = participants with a normal parameter value (within reference range) at baseline and also with at least one on-treatment value. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Safety Laboratory Assessments - Number of Participants With a Shift in Laboratory Parameters Baseline Values to the Minimum Values | Baseline up to approximately 5 years and 11 months | The Full Analysis Set included all participants who entered the extension study and who subsequently received at least 1 dose of Chronocort. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. Number analyzed for each parameter = participants with a normal parameter value (within reference range) at baseline and also with at least one on-treatment value. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Safety and Tolerability - Change From Pre-Chronocort Baseline to Month 30 in Vital Signs - Diastolic Blood Pressure | Baseline, Month 30 | The Full Analysis Set included all participants who entered the extension study and who subsequently received at least 1 dose of Chronocort. 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. | mmHg | MEAN |
| PRIMARY | Safety and Tolerability - Change From Pre-Chronocort Baseline to Month 30 in Vital Signs - Systolic Blood Pressure | Baseline, Month 30 | The Full Analysis Set included all participants who entered the extension study and who subsequently received at least 1 dose of Chronocort. 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. | mmHg | MEAN |
| PRIMARY | Safety and Tolerability - Change From Pre-Chronocort Baseline to Month 30 in Vital Signs - Pulse Rate | Baseline, Month 30 | The Full Analysis Set included all participants who entered the extension study and who subsequently received at least 1 dose of Chronocort. 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. | beats/minute | MEAN |
| PRIMARY | Safety and Tolerability - Change From Pre-Chronocort Baseline to Month 30 in Vital Signs - Respiratory Rate | Baseline, Month 30 | The Full Analysis Set included all participants who entered the extension study and who subsequently received at least 1 dose of Chronocort. 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. | breaths/minute | MEAN |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 outcomesResults by group270
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety and Tolerability - Number of Participants With Adrenal Insufficiency | Chronocort® | Due to GC over-replacement | 25 | Participants | |
| Safety and Tolerability - Number of Participants With Adrenal Insufficiency | Chronocort® | Due to GC under-replacement | 41 | Participants | |
| Safety and Tolerability - Number of Participants Who Used Sick Day Medication | Chronocort® | Participants Taking Medication From Sick Day Packs | 79 | Participants | |
| Safety and Tolerability - Number of Participants Who Used Sick Day Medication | Chronocort® | Participants Taking Medication That Was Not From Sick Day Packs | 47 | Participants | |
| Safety and Tolerability - Number of Participants Who Experienced at Least One Adrenal Crisis | Chronocort® | 7 | Participants | ||
| Safety and Tolerability - Number of Participants With Adverse Events (AEs) | Chronocort® | Any AE | 90 | Participants | |
| Safety and Tolerability - Number of Participants With Adverse Events (AEs) | Chronocort® | Any AE causally related to Chronocort | 37 | Participants | |
| Safety and Tolerability - Number of Participants With Adverse Events (AEs) | Chronocort® | Any AE leading to sick day rules | 80 | Participants | |
| Safety and Tolerability - Number of Participants With Adverse Events (AEs) | Chronocort® | Any AE leading to sick day rules causally related to Chronocort | 1 | Participants | |
| Safety and Tolerability - Number of Participants With Adverse Events (AEs) | Chronocort® | Any AE leading to adrenal crisis | 7 | Participants |
1 to 10 of 270Source ClinicalTrials.gov
See all 270 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Chronocort® | 91 | |
| Overall Study | COMPLETED | Chronocort® | 69 | |
| Overall Study | NOT COMPLETED | Chronocort® | 22 |
Source ClinicalTrials.gov
Adverse events364
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 | 91 | 1 |
| other | Appendicitis | Infections and infestations | Chronocort® | 1 | 91 | 1 |
| other | Bacterial vaginosis | Infections and infestations | Chronocort® | 2 | 62 | 4 |
| other | Balanitis candida | Infections and infestations | Chronocort® | 1 | 91 | 1 |
| other | Bronchitis | Infections and infestations | Chronocort® | 10 | 91 | 23 |
| other | COVID-19 | Infections and infestations | Chronocort® | 17 | 91 | 18 |
| other | Candida infection | Infections and infestations | Chronocort® | 1 | 91 | 1 |
| other | Cystitis | Infections and infestations | Chronocort® | 4 | 91 | 8 |
| other | Device related infection | Infections and infestations | Chronocort® | 1 | 91 | 1 |
| other | Ear infection | Infections and infestations | Chronocort® | 4 | 91 | 4 |
1 to 10 of 364Source ClinicalTrials.gov
See all 364 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Chronocort® | 1 | 91 |
| Total, other adverse events | Chronocort® | 90 | 91 |
| Total, serious adverse events | Chronocort® | 28 | 91 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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/NCT03062280
GET https://conductscience.org/api/trials/v1/NCT03062280/registered?page=2