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 range18 Years

SexALL

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®.
✕. Subjects unable to comply with the requirements of the protocol.

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

Safety and Tolerability - Change From Pre-Chronocort Baseline to Month 30 in Vital Signs - Diastolic Blood Pressure

Timeframe: Baseline, Month 30

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 range18 Years

SexALL

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®.
✕. Subjects unable to comply with the requirements of the protocol.

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

Safety and Tolerability - Change From Pre-Chronocort Baseline to Month 30 in Vital Signs - Diastolic Blood Pressure

Timeframe: Baseline, Month 30