Chronocort ( DrugBank: - )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 81 | 先天性副腎皮質酵素欠損症 | 20 |
81. 先天性副腎皮質酵素欠損症
臨床試験数 : 87 / 薬物数 : 87 - (DrugBank : 23) / 標的遺伝子数 : 12 - 標的パスウェイ数 : 68
Showing 1 to 10 of 20 diseases
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05299554 (ClinicalTrials.gov) | April 1, 2022 | 5/1/2022 | Long-term Safety Study of Chronocort in the Treatment of Participants With Congenital Adrenal Hyperplasia Long-term Safety Study of Chronocortin the Treatment of Participants With Congenital Adrenal Hyperpl ... | A Phase 3 Open-Label Extension Study to Evaluate the Long-term Safety and Tolerability of Chronocort in the Treatment of Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia A Phase 3 Open-Label Extension Study to Evaluate the Long-term Safety and Tolerability of Chronocort ... | Congenital Adrenal Hyperplasia | Drug: Chronocort | Diurnal Limited | NULL | Enrolling by invitation | 16 Years | N/A | All | 181 | Phase 3 | United States;France |
| 2 | JPRN-jRCT2031210491 | 04/01/2022 | 17/12/2021 | Double-blind comparison of Chronocort versus standard hydrocortisonereplacement therapy in participants aged 16 years and over with congenital adrenalhyperplasia Double-blind comparison of Chronocortversus standard hydrocortisonereplacement therapy in participan ... | A randomized, Double-Blind, Active-Controlled, Phase 3 Study ofChronocort Compared with Immediate-Release Hydrocortisone Replacement Therapy inParticipants Aged 16 Years and Over with Congenital Adrenal Hyperplasia A randomized, Double-Blind, Active-Controlled, Phase 3 Study ofChronocort Compared with Immediate-Re ... | Congenital adrenal hyperplasia (CAH) | Participants randomized to Chronocort will receive 10 mg Chronocort in the morning on waking (typically between 06:00 and 08:00), placebo in the afternoon (between 15:00 and 17:00) and 20 mg Chronocort at night just prior to going to bed (typically between 22:00 and midnight). A maximum of 3 dose reductions will be allowed, resulting in a minimum final dose of 15 mg a day. Participants randomized to immediate-release hydrocortisone (IRHC) will receive 20 mg IRHC in the morning on waking (typically between 06:00 and 08:00), 10 mg IRHC in the afternoon (between 15:00 and 17:00) and placebo at night just prior to going to bed (typically between 22:00 and midnight). A maximum of 3 dose reductions will be allowed, resulting in a minimum final dose of 15 mg a day. The dose for both groups will be adjusted by an Independent blinded physician based on the androgen levels and adrenal function at Weeks 4, 10, and 16. At Week 16 the dose will be fixed and should remain unchanged. The blinded titrator can complete a dose increase at week 32 of 5 mg based on androgen results and adrenal function. Additionally, if a participant shows persistent signs of under replacement the Investigator can request 1 dose reversion of 5 mg, this will be discussed and agreed by the medical monitor. Participants randomized to Chronocortwill receive 10 mg Chronocortin the morning on waking (typicall ... | Fujii Katsuya | NULL | Recruiting | >= 16age old | Not applicable | Both | 15 | Phase 2 | US;France;Turkey;Japan |
| 3 | NCT05063994 (ClinicalTrials.gov) | December 13, 2021 | 28/5/2021 | Comparison of Chronocort Versus Standard Hydrocortisone Replacement Therapy in Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia Comparison of ChronocortVersus Standard Hydrocortisone Replacement Therapy in Participants Aged 16 Y ... | A Randomized, Double-Blind, Active-Controlled, Phase 3 Study of Chronocort Compared With Immediate-Release Hydrocortisone Replacement Therapy in Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia A Randomized, Double-Blind, Active-Controlled, Phase 3 Study of ChronocortCompared With Immediate-Re ... | Congenital Adrenal Hyperplasia | Drug: Chronocort;Drug: Cortef | Diurnal Limited | NULL | Recruiting | 16 Years | N/A | All | 150 | Phase 3 | United States;France;Japan |
| 4 | NCT03532022 (ClinicalTrials.gov) | October 4, 2018 | 18/4/2018 | Open-label Comparison of Chronocort® Versus Standard Glucocorticoid Replacement Therapy | An Open-label, Randomized, Titration-blinded, Phase III Study of Efficacy, Safety and Tolerability Of Chronocort® Compared With Standard Glucocorticoid REeplacement Therapy in the Treatment of Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia An Open-label, Randomized, Titration-blinded, Phase III Study of Efficacy, Safety and Tolerability O ... | Congenital Adrenal Hyperplasia | Drug: Chronocort®;Drug: Standard Care | Diurnal Limited | National Institutes of Health (NIH) | Withdrawn | 16 Years | N/A | All | 0 | Phase 3 | United States |
| 5 | EUCTR2015-005448-32-DK (EUCTR) | 01/09/2017 | 28/06/2017 | 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. The proposed study aims to build on the results of clinical studies DIUR-003 and DIUR-005 and evalua ... | A Phase III extension study of efficacy, safety and tolerability of Chronocort® in the treatment of congenital adrenal hyperplasia (CAH) A Phase III extension study of efficacy, safety and tolerability of Chronocort® in the treatment of ... | Congenital adrenal hyperplasia (CAH); is generally due to 21-hydroxylase deficiency, is a disease of the adrenal cortex characterised by cortisol deficiency with or without aldosterone deficiency, and androgen excess. Subjects with CAH are at risk of developing a number of clinical manifestations, such as obesity in children, insulin resistance, and polycystic ovaries, which may contribute to infertility in women with CAH. Oligomenorrhoea or amenorrhoea may be present in adolescence. MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Hormonal diseases [C19] Congenital adrenal hyperplasia (CAH); is generally due to 21-hydroxylase deficiency, is a disease of ... | Product Name: Chronocort® Product Code: DIURF-006 INN or Proposed INN: HYDROCORTISONE Other descriptive name: Cortisol Product Name: Chronocort® Product Code: DIURF-006 INN or Proposed INN: HYDROCORTISONE Other descriptive ... | Diurnal Ltd | NULL | Not Recruiting | Female: yes Male: yes | 136 | Phase 3 | France;United States;Denmark;Netherlands;Germany;United Kingdom;Sweden | ||
| 6 | EUCTR2015-005448-32-SE (EUCTR) | 09/02/2017 | 06/09/2016 | 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. The proposed study aims to build on the results of clinical studies DIUR-003 and DIUR-005 and evalua ... | A Phase III extension study of efficacy, safety and tolerability of Chronocort® in the treatment of congenital adrenal hyperplasia (CAH) A Phase III extension study of efficacy, safety and tolerability of Chronocort® in the treatment of ... | Congenital adrenal hyperplasia (CAH); is generally due to 21-hydroxylase deficiency, is a disease of the adrenal cortex characterised by cortisol deficiency with or without aldosterone deficiency, and androgen excess. Subjects with CAH are at risk of developing a number of clinical manifestations, such as obesity in children, insulin resistance, and polycystic ovaries, which may contribute to infertility in women with CAH. Oligomenorrhoea or amenorrhoea may be present in adolescence. MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] Congenital adrenal hyperplasia (CAH); is generally due to 21-hydroxylase deficiency, is a disease of ... | Product Name: Chronocort® Product Code: DIURF-006 INN or Proposed INN: HYDROCORTISONE Other descriptive name: Cortisol Product Name: Chronocort® Product Code: DIURF-006 INN or Proposed INN: HYDROCORTISONE Other descriptive ... | Diurnal Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 138 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (P ... | France;United States;Denmark;Germany;United Kingdom;Sweden | ||
| 7 | EUCTR2015-005448-32-DE (EUCTR) | 31/01/2017 | 02/11/2016 | 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. The proposed study aims to build on the results of clinical studies DIUR-003 and DIUR-005 and evalua ... | A Phase III extension study of efficacy, safety and tolerability of Chronocort® in the treatment of congenital adrenal hyperplasia A Phase III extension study of efficacy, safety and tolerability of Chronocort® in the treatment of ... | Congenital adrenal hyperplasia (CAH); is generally due to 21-hydroxylase deficiency, is a disease of the adrenal cortex characterised by cortisol deficiency with or without aldosterone deficiency, and androgen excess. Subjects with CAH are at risk of developing a number of clinical manifestations, such as obesity in children, insulin resistance, and polycystic ovaries, which may contribute to infertility in women with CAH. Oligomenorrhoea or amenorrhoea may be present in adolescence. MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Hormonal diseases [C19] Congenital adrenal hyperplasia (CAH); is generally due to 21-hydroxylase deficiency, is a disease of ... | Product Name: Chronocort® 5 mg Product Code: DIURF-006 INN or Proposed INN: HYDROCORTISONE Other descriptive name: Cortisol Product Name: Chronocort® 10 mg Product Code: DIURF-006 INN or Proposed INN: HYDROCORTISONE Other descriptive name: Cortisol Product Name: Chronocort® 20 mg Product Code: DIURF-006 INN or Proposed INN: HYDROCORTISONE Other descriptive name: Cortisol Product Name: Chronocort® 5 mg Product Code: DIURF-006 INN or Proposed INN: HYDROCORTISONE Other descri ... | Diurnal Ltd | NULL | Not Recruiting | Female: yes Male: yes | 136 | Phase 3 | United States;France;Denmark;Germany;United Kingdom;Sweden | ||
| 8 | EUCTR2015-000711-40-DK (EUCTR) | 08/09/2016 | 11/07/2016 | Chronocort®, a slow release medicinal preparation of hydrocortisone, will be compared with currently used glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia seeking to assess its safety, tolerability and effectiveness. Chronocort®, a slow release medicinal preparation of hydrocortisone, will be compared with currently ... | A Phase III study of efficacy, safety and tolerability of Chronocort® compared with standard glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia. A Phase III study of efficacy, safety and tolerability of Chronocort® compared with standard glucoco ... | Congenital adrenal hyperplasia (CAH); is generally due to 21-hydroxylase deficiency, is a disease of the adrenal cortex characterised by cortisol deficiency with or without aldosterone deficiency, and androgen excess. Subjects with CAH are at risk of developing a number of clinical manifestations, such as obesity in children, insulin resistance, and polycystic ovaries, which may contribute to infertility in women with CAH. Oligomenorrhoea or amenorrhoea may be present in adolescence. MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000012082;Therapeutic area: Diseases [C] - Hormonal diseases [C19] Congenital adrenal hyperplasia (CAH); is generally due to 21-hydroxylase deficiency, is a disease of ... | Product Name: Chronocort® Product Code: DIURF-006 INN or Proposed INN: HYDROCORTISONE Other descriptive name: Cortisol Trade Name: Hydrocortisone 10mg Tablets INN or Proposed INN: Hydrocortisone Other descriptive name: HYDROCORTISONE Trade Name: Dexamethasone 0,1 mg Tablets INN or Proposed INN: DEXAMETHASONE Trade Name: Prednisolone 2,5 mg Tablets INN or Proposed INN: Prednisolone Other descriptive name: PREDNISOLONE Product Name: Hydrocortisone tablet 2.5 mg Product Name: Chronocort® Product Code: DIURF-006 INN or Proposed INN: HYDROCORTISONE Other descriptive ... | Diurnal Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 3 | France;United States;Denmark;Netherlands;Germany;United Kingdom;Sweden | ||
| 9 | NCT03062280 (ClinicalTrials.gov) | August 18, 2016 | 22/8/2016 | A Study of the Efficacy, Safety and Tolerability of Chronocort in Treating CAH | A Phase III Extension Study of Efficacy, Safety and Tolerability of Chronocort® in the Treatment of Congenital Adrenal Hyperplasia A Phase III Extension Study of Efficacy, Safety and Tolerability of Chronocort® in the Treatment of ... | Congenital Adrenal Hyperplasia | Drug: Hydrocortisone | Diurnal Limited | NULL | Completed | 18 Years | N/A | All | 92 | Phase 3 | United States |
| 10 | EUCTR2015-005448-32-GB (EUCTR) | 20/07/2016 | 05/07/2016 | 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. The proposed study aims to build on the results of clinical studies DIUR-003 and DIUR-005 and evalua ... | A Phase III extension study of efficacy, safety and tolerability of Chronocort® in the treatment of congenital adrenal hyperplasia (CAH) A Phase III extension study of efficacy, safety and tolerability of Chronocort® in the treatment of ... | Congenital adrenal hyperplasia (CAH); is generally due to 21-hydroxylase deficiency, is a disease of the adrenal cortex characterised by cortisol deficiency with or without aldosterone deficiency, and androgen excess. Subjects with CAH are at risk of developing a number of clinical manifestations, such as obesity in children, insulin resistance, and polycystic ovaries, which may contribute to infertility in women with CAH. Oligomenorrhoea or amenorrhoea may be present in adolescence. MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Hormonal diseases [C19] Congenital adrenal hyperplasia (CAH); is generally due to 21-hydroxylase deficiency, is a disease of ... | Product Name: Chronocort® Product Code: DIURF-006 INN or Proposed INN: HYDROCORTISONE Other descriptive name: Cortisol Product Name: Chronocort® Product Code: DIURF-006 INN or Proposed INN: HYDROCORTISONE Other descriptive ... | Diurnal Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 136 | Phase 3 | France;United States;Denmark;Netherlands;Germany;United Kingdom;Sweden |