CompletedPhase 3

A Study of the Efficacy, Safety and Tolerability of Chronocort in Treating CAH

United States91 participantsStarted 2016-08-18

Plain-language summary

Subjects completing study DIUR-005 and those who have already completed study DIUR-003 will be offered the opportunity either to continue Chronocort® therapy or to switch from their current glucocorticoid therapy to Chronocort® in this open-label study.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Subjects with CAH who have successfully completed a clinical trial with the current formulation of Chronocort®.
. Provision of signed written informed consent.

Exclusion criteria

. Co-morbid condition requiring daily administration of a medication (or use of any medications/supplements) that interferes with the metabolism of glucocorticoids.
. Clinical or biochemical evidence of hepatic or renal disease. Creatinine over twice the ULN or elevated liver function tests (ALT or AST \>2 times ULN\]).
. Females who are pregnant or lactating.
. Subjects on regular daily inhaled, topical, nasal or oral steroids for any indication other than CAH.
. History of malignancy (other than basal cell carcinoma successfully treated \>6 months prior to entry into the study).
. Subjects with a history of bilateral adrenalectomy.
. Participation in another clinical trial of an investigational or licensed drug or device within the 3 months prior to inclusion in this study, except for another clinical trial with the current formulation of Chronocort®.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety and Tolerability - Number of Participants With Adrenal Insufficiency

Timeframe: Up to approximately 5 years and 11 months

Safety and Tolerability - Number of Participants Who Used Sick Day Medication

Timeframe: Up to approximately 5 years and 11 months

Safety and Tolerability - Number of Participants Who Experienced at Least One Adrenal Crisis

Timeframe: Up to approximately 5 years and 11 months

Safety and Tolerability - Number of Participants With Adverse Events (AEs)

Timeframe: Up to approximately 5 years and 11 months

Safety Laboratory Assessments - Number of Participants With a Shift in Laboratory Parameters Baseline Values to the Maximum Values

Timeframe: Baseline up to approximately 5 years and 11 months

Safety Laboratory Assessments - Number of Participants With a Shift in Laboratory Parameters Baseline Values to the Minimum Values

Timeframe: Baseline up to approximately 5 years and 11 months

Trial details

NCT IDNCT03062280

SponsorNeurocrine UK Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-07-13

Results submitted2023-07-13

View on ClinicalTrials.gov More Congenital Adrenal Hyperplasia trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Subjects with CAH who have successfully completed a clinical trial with the current formulation of Chronocort®.
. Provision of signed written informed consent.

Exclusion criteria

. Co-morbid condition requiring daily administration of a medication (or use of any medications/supplements) that interferes with the metabolism of glucocorticoids.
. Clinical or biochemical evidence of hepatic or renal disease. Creatinine over twice the ULN or elevated liver function tests (ALT or AST \>2 times ULN\]).
. Females who are pregnant or lactating.
. Subjects on regular daily inhaled, topical, nasal or oral steroids for any indication other than CAH.
. History of malignancy (other than basal cell carcinoma successfully treated \>6 months prior to entry into the study).
. Subjects with a history of bilateral adrenalectomy.
. Participation in another clinical trial of an investigational or licensed drug or device within the 3 months prior to inclusion in this study, except for another clinical trial with the current formulation of Chronocort®.

What they're measuring

Safety and Tolerability - Number of Participants With Adrenal Insufficiency

Timeframe: Up to approximately 5 years and 11 months

Safety and Tolerability - Number of Participants Who Used Sick Day Medication

Timeframe: Up to approximately 5 years and 11 months

Safety and Tolerability - Number of Participants Who Experienced at Least One Adrenal Crisis

Timeframe: Up to approximately 5 years and 11 months

Safety and Tolerability - Number of Participants With Adverse Events (AEs)

Timeframe: Up to approximately 5 years and 11 months

Safety Laboratory Assessments - Number of Participants With a Shift in Laboratory Parameters Baseline Values to the Maximum Values

Timeframe: Baseline up to approximately 5 years and 11 months

Safety Laboratory Assessments - Number of Participants With a Shift in Laboratory Parameters Baseline Values to the Minimum Values

Timeframe: Baseline up to approximately 5 years and 11 months