The proposed study aims to build on the results of clinical studies DIUR-003 and DIUR-005 and evaluate the long-term safety of Chronocort® and also its long term efficacy.

A Phase III extension study of efficacy, safety and tolerability of Chronocort® in the treatment of congenital adrenal hyperplasia (CAH)

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005448-32-GB

Enrollment

136

Registered

2016-07-05

Start date

2016-07-20

Completion date

Unknown

Last updated

2018-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital adrenal hyperplasia (CAH)

Interventions

Product Name: Chronocort® Product Code: DIURF-006 Pharmaceutical Form: Capsule INN or Proposed INN: HYDROCORTISONE CAS Number: 50-23-7 Other descriptive name: Cortisol Concentration unit: mg milligram

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Subjects with congenital adrenal hyperplasia (CAH) who have successfully completed the DIUR-003 or DIUR-005 clinical trials with the current formulation of Chronocort® 2. Provision of signed written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 136 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Co-morbid condition requiring daily administration of a medication (or consumption of any material) that interferes with the metabolism of glucocorticoids 2. Clinical or biochemical evidence of hepatic or renal disease. Creatinine over twice the ULN or elevated liver function tests (ALT or AST >2 times the ULN) 3. Subjects on regular daily inhaled, topical, nasal or oral steroids for any indication other than CAH 4. History of malignancy (other than basal cell carcinoma successfully treated >6 months prior to entry into the study) 5. Participation in another clinical trial of an investigational or licensed drug or device within the 3 months prior to inclusion in this study 6. Subjects with a history of bilateral adrenalectomy 7. Subjects unable to comply with the requirements of the protocol.

Design outcomes

Primary

Measure	Time frame
Secondary Objective: The long-term efficacy of Chronocort® will be assessed over time by the measurement of: 1. Total daily dose in mg/day of hydrocortisone during the study and the incidence of dose titrations 2. 17-hydroxyprogesterone (17-OHP) and androstenedione (A4), measured at two time points (at 09:00 and 13:00 hours) for: a. Disease control at each visit as assessed by both 17-OHP and A4 levels in the optimal and normal range, respectively, at both time points. b. 17-OHP and A4 standard deviation scores c. Change in absolute values compared to pre-Chronocort® baseline values 3. Changes compared to pre-Chronocort® baseline in: a. Bone turnover markers - serum C-terminal cross-linked telopeptide, osteocalcin b. Testosterone c. Fasting insulin and blood glucose levels and glycated haemoglobin d. High sensitivity c-reactive protein and plasma renin activity e. Body composition (dual energy X-ray absorptiometry) f. Quality of life – SF-36®, Multidimensional Assessment of Fatigue, EQ-5D™;Primary end point(s): The primary endpoint is the safety of Chronocort® over time, assessed using but not limited to the following endpoints throughout the study: 1. Signs and symptoms of adrenal insufficiency or over-treatment 2. Use of sick day rules 3. Occurrence of adrenal crises 4. Occurrence of AEs 5. Change from pre-Chronocort® baseline in safety laboratory assessments at each visit 6. Change from pre-Chronocort® baseline in vital signs, weight, body mass index, and waist circumference at each visit.;Timepoint(s) of evaluation of this end point: Each visit throughout the study;Main Objective: To assess safety and tolerability of Chronocort® over time, as assessed by signs and symptoms of adrenal insufficiency or over-treatment, use of sick day rules, adrenal crisis, adverse events (AEs), laboratory measures and clinical observation.	—

Measure

Time frame

Secondary Objective: The long-term efficacy of Chronocort® will be assessed over time by the measurement of: 1. Total daily dose in mg/day of hydrocortisone during the study and the incidence of dose titrations 2. 17-hydroxyprogesterone (17-OHP) and androstenedione (A4), measured at two time points (at 09:00 and 13:00 hours) for: a. Disease control at each visit as assessed by both 17-OHP and A4 levels in the optimal and normal range, respectively, at both time points. b. 17-OHP and A4 standard deviation scores c. Change in absolute values compared to pre-Chronocort® baseline values 3. Changes compared to pre-Chronocort® baseline in: a. Bone turnover markers - serum C-terminal cross-linked telopeptide, osteocalcin b. Testosterone c. Fasting insulin and blood glucose levels and glycated haemoglobin d. High sensitivity c-reactive protein and plasma renin activity e. Body composition (dual energy X-ray absorptiometry) f. Quality of life – SF-36®, Multidimensional Assessment of Fatigue, EQ-5D™;Primary end point(s): The primary endpoint is the safety of Chronocort® over time, assessed using but not limited to the following endpoints throughout the study: 1. Signs and symptoms of adrenal insufficiency or over-treatment 2. Use of sick day rules 3. Occurrence of adrenal crises 4. Occurrence of AEs 5. Change from pre-Chronocort® baseline in safety laboratory assessments at each visit 6. Change from pre-Chronocort® baseline in vital signs, weight, body mass index, and waist circumference at each visit.;Timepoint(s) of evaluation of this end point: Each visit throughout the study;Main Objective: To assess safety and tolerability of Chronocort® over time, as assessed by signs and symptoms of adrenal insufficiency or over-treatment, use of sick day rules, adrenal crisis, adverse events (AEs), laboratory measures and clinical observation.

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Secondary

Measure	Time frame
Secondary end point(s): The following secondary endpoints will be assessed (seeking to assess long term efficacy): 1. Total daily dose of Chronocort® in mg/day of hydrocortisone 2. Disease control throughout the study as assessed by both 17-OHP and A4 levels in the optimal and normal range, respectively 3. Change from pre-Chronocort® baseline at each visit in SDS of 17-OHP and A4 and the mean of the two timepoints 4. Change from pre-Chronocort® baseline at each visit in the absolute values of 17-OHP and A4 5. Change from pre-Chronocort® baseline at each visit in: a. Bone turnover markers - CTX, osteocalcin b. Testosterone (total) c. Fasting insulin and blood glucose levels, and HbA1c d. hsCRP and PRA g. Body composition (DEXA)(fat mass, lean mass and total bone density) e. Quality of life – SF-36®, MAF, EQ-5D™ 6. Incidence of dose titrations.;Timepoint(s) of evaluation of this end point: At all visits: 1. Measurement of 17-OHP and A4 at two time points (the first at 09:00 and the second at 13:00 hours). At baseline, at each 6-monthly visit and at the final visit: 1. Physical examination, vital signs, weight, BMI and waist circumference. 2. Safety blood tests, serum CTX, osteocalcin, PRA, hsCRP, HbA1c, testosterone, fasting insulin and blood glucose levels. 3. Quality of life – SF-36®, MAF, EQ-5D™ At yearly intervals: 1. Body composition (DEXA)(fat mass, lean mass and total bone density) (also taken at baseline for subjects entering from study DIUR-003).	—

Measure

Time frame

Secondary end point(s): The following secondary endpoints will be assessed (seeking to assess long term efficacy): 1. Total daily dose of Chronocort® in mg/day of hydrocortisone 2. Disease control throughout the study as assessed by both 17-OHP and A4 levels in the optimal and normal range, respectively 3. Change from pre-Chronocort® baseline at each visit in SDS of 17-OHP and A4 and the mean of the two timepoints 4. Change from pre-Chronocort® baseline at each visit in the absolute values of 17-OHP and A4 5. Change from pre-Chronocort® baseline at each visit in: a. Bone turnover markers - CTX, osteocalcin b. Testosterone (total) c. Fasting insulin and blood glucose levels, and HbA1c d. hsCRP and PRA g. Body composition (DEXA)(fat mass, lean mass and total bone density) e. Quality of life – SF-36®, MAF, EQ-5D™ 6. Incidence of dose titrations.;Timepoint(s) of evaluation of this end point: At all visits: 1. Measurement of 17-OHP and A4 at two time points (the first at 09:00 and the second at 13:00 hours). At baseline, at each 6-monthly visit and at the final visit: 1. Physical examination, vital signs, weight, BMI and waist circumference. 2. Safety blood tests, serum CTX, osteocalcin, PRA, hsCRP, HbA1c, testosterone, fasting insulin and blood glucose levels. 3. Quality of life – SF-36®, MAF, EQ-5D™ At yearly intervals: 1. Body composition (DEXA)(fat mass, lean mass and total bone density) (also taken at baseline for subjects entering from study DIUR-003).

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Countries

Denmark, France, Germany, Netherlands, Sweden, United Kingdom, United States

Contacts

Public ContactClinical Trials Information

Diurnal Ltd

info@diurnal.co.uk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026