17 completed, 1 withdrawn. 10 Phase 1, 6 Phase 3, 3 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 10 | Completed 10 |
| Phase 3 | 6 | Completed 5, Withdrawn 1 |
| Phase 2 | 3 | Completed 3 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Comparison of Chronocort Versus Standard Hydrocortisone Replacement Therapy in Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia Chronocort, Cortef, Placebo - Congenital Adrenal Hyperplasia | Phase 3 | Completed | Neurocrine UK Limited | 55 | 2022-05-24 | 2026-10-02 |
| Chronocort Versus Plenadren Replacement Therapy in Adults With Adrenal Insufficiency Chronocort, Plenadren - Primary Adrenal Insufficiency | Phase 2 | Completed | Neurocrine UK Limited | 58 | 2021-11-23 | 2026-09-14 |
| Open-label Comparison of Chronocort® Versus Standard Glucocorticoid Replacement Therapy Chronocort®, Standard Care - Congenital Adrenal Hyperplasia | Phase 3 | Withdrawn | Neurocrine UK Limited | 2018-10-04 | 2026-09-14 | |
| A Study of Infacort® Versus Cortef® in Healthy Adult Male and Female Subjects Infacort®, Cortef® - Adrenal Insufficiency | Phase 1 | Completed | Neurocrine UK Limited | 51 | 2018-04-16 | 2026-09-14 |
| A Study of Chronocort® Versus Cortef ® in Healthy Adult Male Subjects Chronocort®, Cortef® - Adrenal Insufficiency | Phase 1 | Completed | Neurocrine UK Limited | 25 | 2018-02-19 | 2026-09-14 |
| Bioavailability of Infacort When Administered Onto Food Compared to Direct Oral Administration Infacort - Adrenal Insufficiency | Phase 1 | Completed | Neurocrine UK Limited | 19 | 2017-05-22 | 2026-09-14 |
| Study to Compare DITEST to Testosterone Undecanoate in Adult Men With Hypogonadism DITEST, Testosterone undecanoate - Male Hypogonadism | Phase 1 | Completed | Neurocrine UK Limited | 25 | 2016-11-03 | 2026-09-14 |
| A Study of the Efficacy, Safety and Tolerability of Chronocort in Treating CAH Hydrocortisone - Congenital Adrenal Hyperplasia | Phase 3 | Completed | Neurocrine UK Limited | 91 | 2016-08-18 | 2026-10-02 |
| Extension Study for Patients Entered Into Study Infacort 003 Infacort® - Adrenal Insufficiency | Phase 3 | Completed | Neurocrine UK Limited | 18 | 2016-03-04 | 2026-10-02 |
| Comparison of Chronocort® With Standard Glucocorticoid Therapy in Patients With Congenital Adrenal Hyperplasia Chronocort®, standard glucocorticoid therapy - Congenital Adrenal Hyperplasia | Phase 3 | Completed | Neurocrine UK Limited | 122 | 2016-02-22 | 2026-10-02 |
| Treatment of Adrenal Insufficiency in Children Infacort® - Adrenal Insufficiency | Phase 3 | Completed | Neurocrine UK Limited | 24 | 2015-03-01 | 2026-10-02 |
| Effect of Slow Release Hydrocortisone on Fed & Fasting Volunteers; Immediate Release on Fasting Only Dexamethasone, Chronocort: fasted, Immediate release hydrocortisone: fasted - Healthy | Phase 1 | Completed | Neurocrine UK Limited | 18 | 2015-01-01 | 2022-05-04 |
| An Investigational Study of Hydrocortisone Hydrocortisone granules, Hydrocortisone Tablet, i.v. Hydrocortisone Injection - Adrenal Insufficiency | Phase 1 | Completed | Neurocrine UK Limited | 14 | 2013-10-01 | 2026-10-02 |
| Comparison of Pharmacokinetics of Infacort® Versus Immediate-release Hydrocortisone Infacort, Hydrocortisone - Healthy Subjects | Phase 1 | Completed | Neurocrine UK Limited | 16 | 2013-07-01 | 2026-10-02 |
| Pilot Study to Characterize and Examine the Pharmacokinetics and Efficacy of Chronocort® in Adults With CAH Hydrocortisone Modified Release Capsules - Endocrine Disease, Adrenal Insufficiency | Phase 2 | Completed | Neurocrine UK Limited | 16 | 2012-12-01 | 2026-10-02 |
| A Two-part, Study to Compare the Pharmacokinetics and Dose Proportionality of up to 6 Chronocort Formulations Chronocort - Adrenal Insufficiency, Congenital Adrenal Hyperplasia | Phase 1 | Completed | Neurocrine UK Limited | 28 | 2011-02-01 | 2026-09-14 |
| An Open Label Study in Healthy Volunteers to Compare Chronocort® to Hydrocortisone Hydrocortisone, Chronocort - Congenital Adrenal Hyperplasia, Adrenal Insufficiency | Phase 1 | Completed | Neurocrine UK Limited | 30 | 2010-03-01 | 2026-09-14 |
| Comparison of Two Forms of Hydrocortisone in Patients With Congenital Adrenal Hyperplasia Chronocort, Cortef - Congenital Adrenal Hyperplasia, 21-Hydroxylase Deficiency | Phase 1 / Phase 2 | Completed | Neurocrine UK Limited | 20 | 2007-08-01 | 2022-04-26 |
Adrenal Insufficiency (9) · Adrenal Hyperplasia, Congenital (8) · Addison Disease (1) · Adrenogenital Syndrome (1) · Congenital adrenal hyperplasia due to 21 hydroxylase deficiency (1) · Endocrine System Diseases (1) · Eunuchism (1) · Hypogonadism (1) · Neoplasm Metastasis (1)
Hydrocortisone (11) · Dexamethasone (4) · Prednisolone (2) · Prednisone (2) · Standard of Care (1) · testosterone undecanoate (1)
United Kingdom (6) · United States (6) · Germany (3) · France (1) · Japan (1)
A Koch (2) · Girish Sharma (2) · Debbie Merke, MD (1) · Deborah P Merke, BS, MS, MD (1) · Girish Sharma, MD (1) · J Newell-Price, MA, PhD (1) · Salvatore Febbraro (1) · Susanna Wiegand, MD (1)