Hydrocortisone (DrugBank: Hydrocortisone)
9 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 6 | パーキンソン病 | 1 |
| 46 | 悪性関節リウマチ | 1 |
| 53 | シェーグレン症候群 | 3 |
| 75 | クッシング病 | 2 |
| 78 | 下垂体前葉機能低下症 | 3 |
| 81 | 先天性副腎皮質酵素欠損症 | 28 |
| 83 | アジソン病 | 12 |
| 97 | 潰瘍性大腸炎 | 5 |
| 299 | 嚢胞性線維症 | 1 |
| 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 | NCT02230930 (ClinicalTrials.gov) | June 2015 | 29/8/2014 | Treatment of Apomorphine-induced Skin Reactions: a Pilot Study | Open-label Crossover Trial to Investigate the Efficacy of Treatments in Apomorphine-induced Skin Reactions | Parkinson's Disease;Apomorphine-induced Skin Reactions | Drug: Apomorphine 0.25% (2.5mg/ml);Device: Massage with a spiky ball;Drug: Hydrocortisone cream 1%;Drug: Subcutaneous hydrocortisone 10mg | University Medical Center Groningen | NULL | Recruiting | 30 Years | N/A | All | 20 | Phase 2 | Netherlands |
| 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 | EUCTR2016-001618-18-FR (EUCTR) | 08/07/2016 | 09/06/2016 | Comparison of two STrategies of glucocorticoid withdrawal in rheumatoid Arthritis patients | STARComparison of two STrategies of glucocorticoid withdrawal in rheumatoid Arthritis patients in low disease activity or Remission - STAR | glucocorticoid withdrawal in rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Prednisone Product Name: prednisone 5 mg Trade Name: Prednisone Product Name: prednisone 4 mg Trade Name: Prednisone Product Name: prednisone 3 mg Trade Name: Prednisone Product Name: prednisone 2 mg Trade Name: Prednisone Product Name: prednisone 1 mg Trade Name: Hydrocortisone 10mg | CHU Toulouse | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 122 | Phase 4 | France |
| 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 | NCT04597762 (ClinicalTrials.gov) | October 31, 2020 | 16/10/2020 | Effect of Ciclosporin Eyedrops on Sjögren Syndrome | Effect of Ciclosporin Eyedrops on Ocular Symptoms and Optical Quality in Patients With Sjögren Syndrome | Dry Eye Syndromes | Drug: Cyclosporin;Drug: Hydrocortisone | Hospital Hietzing | NULL | Recruiting | 18 Years | 90 Years | All | 12 | N/A | Austria |
| 2 | EUCTR2017-004929-33-AT (EUCTR) | 05/12/2018 | 27/11/2018 | Effect of Ciclosporin eyedrops on symptoms of the eye and visual quality in patients with dry eye syndrome and primary or secondary Sjögren syndrome | Effect of Ciclosporin eyedrops on ocular symptoms and optical image quality in patients with primary or secondary Sjögren syndrome | primary or secondary Sjögren Syndrome;Therapeutic area: Diseases [C] - Eye Diseases [C11] | Trade Name: Ikervis Product Name: Ikervis INN or Proposed INN: CICLOSPORIN Trade Name: Softacort Product Name: Softacort INN or Proposed INN: HYDROCORTISONE SODIUM PHOSPHATE | KH Hietzing, Department of Ophthalmology | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 4 | Austria | ||
| 3 | NCT02112019 (ClinicalTrials.gov) | June 2014 | 8/4/2014 | Endoscopic Treatment of Salivary Glands Affected by Sjögren's Syndrome | Endoscopic Treatment of Salivary Glands Affected by Sjögren's Syndrome; A Randomised Controlled Pilot Study | Sjögren's Syndrome | Procedure: Sialoendoscopy;Drug: saline;Drug: hydrocortisone | Derk Jan Jager | NULL | Active, not recruiting | 18 Years | 70 Years | All | 50 | N/A | Netherlands |
| 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 | JPRN-UMIN000041513 | 2014/07/01 | 01/09/2020 | A new perioperative glucocorticosteroid replacement therapy for cushing syndrome | A new perioperative glucocorticosteroid replacement therapy for cushing syndrome - A perioperative glucocorticosteroid replacement therapy | Perioperative | Hydrocortisone was given during adrenal resection by intravenous injectionon the surgical day. | Tianjin Medical University General Hospital | NULL | Recruiting | 22years-old | 61years-old | Male and Female | 80 | Not selected | Asia(except Japan) |
| 2 | NCT02889224 (ClinicalTrials.gov) | February 2012 | 30/8/2016 | In Vivo Study of Interactions Between the Endocannabinoid System and the Corticotropic Axis in Man | In Vivo Study of Interactions Between the Endocannabinoid System and the Corticotropic Axis in Man | Cushing's Syndrome | Other: Obese;Procedure: Hypercortisolism;Other: Hydrocortisone;Other: Control | University Hospital, Bordeaux | NULL | Completed | 18 Years | N/A | All | 40 | N/A | France |
| 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 | NCT02360046 (ClinicalTrials.gov) | January 2015 | 16/1/2015 | The Influence of Different Hydrocortisone Replacement Doses on the Partitioning and Flexibility of Ectopic Lipids in Patients With Corticotropic Hypopituitarism | The Influence of Different Hydrocortisone Replacement Doses on the Partitioning and Flexibility of Ectopic Lipids (Intrahepatocellular IHCL and Intramyocellular IMCL) in Patients With Corticotropic Hypopituitarism, a Randomised Placebo-controlled Double-blind Trial | Hypopituitarism;Hydrocortisone;Lipids;Fatty Acids, Nonesterified;Insulin Sensitivity | Drug: Hydrocortisone;Drug: Placebo | University Hospital Inselspital, Berne | NULL | Terminated | 18 Years | N/A | All | 30 | N/A | Switzerland |
| 2 | EUCTR2014-002039-32-DK (EUCTR) | 02/09/2014 | 07/07/2014 | Fatigue in patients with adrenal insufficiency - a comparison of the effect of a new modified-release hydrocortisone, and conventional hydrocortisone. | PlenadrEMA study - Effect of modified-release compared to conventional hydrocortisone on fatigue, measured by Ecological Momentary Assessments; a pilot study to assess feasibility, responsiveness of outcomes and to inform power calculations for future large-scale RCTs - PlenadrEMA study | Secondary adrenal insufficiency due to hypopituitarism MedDRA version: 20.0;Level: LLT;Classification code 10052382;Term: Secondary adrenal insufficiency;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Plenadren 5 mg modified-release tablets INN or Proposed INN: Hydrocortisone Other descriptive name: HYDROCORTISONE Trade Name: Hydrocortisone TAKEDA, tabletter INN or Proposed INN: Hydrocortisone Other descriptive name: HYDROCORTISONE Product Name: Hydrokortison Glostrup 5 mg INN or Proposed INN: Hydrocortisone Other descriptive name: HYDROCORTISONE Trade Name: Plenadren 20 mg modified-release tablets INN or Proposed INN: Hydrocortisone Other descriptive name: HYDROCORTISONE | Rigshospitalet, Copenhagen University Hospital | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 4 | Denmark | ||
| 3 | EUCTR2007-005018-37-IE (EUCTR) | 18/01/2008 | 07/09/2007 | Optimal glucocorticoid replacement therapy in adrenocorticotropin (ACTH) deficient hypopituitary patients - Optimal glucocorticoid replacement | Optimal glucocorticoid replacement therapy in adrenocorticotropin (ACTH) deficient hypopituitary patients - Optimal glucocorticoid replacement | 10 male patients with hypopituitarism resulting in ACTH (adrenocorticotropin) deficiency (ICD E23.0) will be studied on varying doses of hydrocortisone replacement therapy. THis is not a new medication for these patients.10 healthy male volunteers will be studied as control subjects. They will NOT receive hydrocortisone. MedDRA version: 9.1;Level: LLT;Classification code 10021067;Term: Hypopituitarism MedDRA version: 9.1;Classification code 10033662;Term: Panhypopituitarism MedDRA version: 9.1;Classification code 10057217;Term: Isolated ACTH deficiency | Trade Name: Hydrocortone INN or Proposed INN: Hydrocortisone INN or Proposed INN: Hydrocortisone | Amar Agha | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 20 | Ireland |
| 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 | NCT03548246 (ClinicalTrials.gov) | January 2022 | 24/4/2015 | Androgen Reduction in Congenital Adrenal Hyperplasia | A Phase 1-2 Multi-Center Study to Assess the Efficacy and Safety of Abiraterone Acetate as Adjunctive Therapy in Pre-Pubescent Children With Classic 21-Hydroxylase Deficiency | Congenital Adrenal Hyperplasia | Drug: Abiraterone acetate;Drug: Placebo;Drug: Hydrocortisone;Drug: Fludrocortisone | University of Texas Southwestern Medical Center | National Institutes of Health Clinical Center (CC);University of Michigan;Children's Hospital Los Angeles;Feinstein Institute for Medical Research | Not yet recruiting | 2 Years | 9 Years | All | 54 | Phase 2 | United States |
| 2 | NCT04536662 (ClinicalTrials.gov) | October 1, 2020 | 23/8/2020 | Comparisons of Different Forms of Glucocorticoid on the Recovery of Reproductive Function in Patients With 21a-hydroxylase Deficiency | Comparisons of Different Forms of Glucocorticoid on the Recovery of Reproductive Function in Patients With 21a-hydroxylase Deficiency | Congenital Adrenal Hyperplasia | Drug: Hydrocortisone;Drug: Prednisone;Drug: Dexamethasone | Shanghai Jiao Tong University School of Medicine | NULL | Not yet recruiting | 14 Years | 45 Years | All | 120 | Phase 4 | China |
| 3 | EUCTR2018-004802-24-NL (EUCTR) | 20/05/2019 | 13/05/2019 | Avoiding over and undertreatment by optimizing of the timing ofglucocorticoïd treatment in children with cnogenital adrenal hyperplasia | Optimizing timing of glucocorticoid treatment in children with congenitaladrenal hyperplasia - OPTIMED study | Congenital adrenal hyperplasia (CAH) is a disorder of adrenal steroidsynthesis leading to cortisol deficiency and an increase in androgenproduction.Treatment in children consists of hydrocortisone substitutionthereby also restoring the negative feedback on the pituitary gland andconsequently normalize androgen production. There is still no evidenceabout the best timing of hydrocortisone use: The highest dosage ofhydrocortisone in the morning or the highest dosage at night;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Hydrocortisone INN or Proposed INN: Hydrocortisone Other descriptive name: HYDROCORTISONE | Radboud University Nijmegen Medical Centre | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Netherlands | ||
| 4 | NCT03718234 (ClinicalTrials.gov) | January 1, 2019 | 11/10/2018 | Subcutaneous Hydrocortisone Children With Congenital Adrenal Hyperplasia | Interval Bolus Delivery of Subcutaneous Hydrocortisone Via Infusion Pump in Children With Congenital Adrenal Hyperplasia | Congenital Adrenal Hyperplasia;Hyperplasia;Adrenal Hyperplasia;Congenital Disorders;Adrenocortical Hyperfunction;Disorders of Sex Development;Urogenital Abnormalities;Genetic Diseases, Inborn;Steroid Metabolic Diseases, Inborn;Adrenal Gland Disease;Hydrocortisone | Drug: Subcutaneous hydrocortisone;Drug: Standard glucocorticoid therapy | University of Minnesota | NULL | Recruiting | 4 Years | 18 Years | All | 8 | Phase 1 | 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. | A Phase III extension study of efficacy, safety and tolerability of Chronocort® in the treatment of congenital adrenal hyperplasia (CAH) | 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] | Product Name: Chronocort® Product Code: DIURF-006 INN or Proposed INN: HYDROCORTISONE Other descriptive name: Cortisol | Diurnal Ltd | NULL | Not Recruiting | Female: yes Male: yes | 136 | Phase 3 | France;United States;Denmark;Netherlands;Germany;United Kingdom;Sweden | ||
| 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 |
| 6 | 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. | A Phase III study of efficacy, safety and tolerability of Chronocort® compared with standard glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia. | 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] | 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 | Diurnal Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 3 | France;United States;Denmark;Netherlands;Germany;United Kingdom;Sweden | ||
| 7 | 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 | Congenital Adrenal Hyperplasia | Drug: Hydrocortisone | Diurnal Limited | NULL | Active, not recruiting | 18 Years | N/A | All | 92 | Phase 3 | United States |
| 8 | NCT03760835 (ClinicalTrials.gov) | August 11, 2016 | 9/11/2018 | Congenital Adrenal Hyperplasia Once Daily Hydrocortisone Treatment | Congenital Adrenal Hyperplasia: Innovative Once Daily Dual Release Hydrocortisone Treatment | Congenital Adrenal Hyperplasia | Drug: Conventional Glucocorticoids (immediate release hydrocortisone, cortisone acetate, prednisone, prednisolone, dexamethasone);Drug: Dual release hydrocortisone (plenadren) | Federico II University | NULL | Recruiting | 18 Years | N/A | All | 150 | Phase 4 | Italy |
| 9 | 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. | A Phase III extension study of efficacy, safety and tolerability of Chronocort® in the treatment of congenital adrenal hyperplasia (CAH) | 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] | Product Name: Chronocort® Product Code: DIURF-006 INN or Proposed INN: HYDROCORTISONE Other descriptive name: Cortisol | 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 | ||
| 10 | EUCTR2015-000711-40-DE (EUCTR) | 23/05/2016 | 06/10/2015 | 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. | A Phase III study of efficacy, safety and tolerability of Chronocort® compared with standard glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia. | 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] | Diurnal Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 3 | France;United States;Denmark;Netherlands;Germany;United Kingdom;Sweden | |||
| 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 |
| 11 | EUCTR2015-000711-40-NL (EUCTR) | 28/04/2016 | 17/11/2015 | 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. | A Phase III study of efficacy, safety and tolerability of Chronocort® compared with standard glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia. | 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: 18.1;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Chronocort® Product Code: DIURF-006 INN or Proposed INN: HYDROCORTISONE Other descriptive name: Cortisol Trade Name: Hydrocortisone 20mg Tablets INN or Proposed INN: Hydrocortisone Other descriptive name: HYDROCORTISONE Trade Name: Dexamethasone 1,5 mg Tablets INN or Proposed INN: DEXAMETHASONE Trade Name: Prednisolone 5 mg Tablets INN or Proposed INN: Prednisolone Other descriptive name: PREDNISOLONE | Diurnal Ltd | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | United States;Denmark;Germany;Netherlands;United Kingdom;Sweden | ||
| 12 | EUCTR2015-000711-40-SE (EUCTR) | 11/01/2016 | 13/10/2015 | 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. | A Phase III study of efficacy, safety and tolerability of Chronocort® compared with standard glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia. | 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] | Product Name: Chronocort® Product Code: DIURF-006 INN or Proposed INN: HYDROCORTISONE Other descriptive name: Cortisol Trade Name: Hydrocortisone 20mg Tablets INN or Proposed INN: Hydrocortisone Other descriptive name: HYDROCORTISONE Trade Name: Dexamethasone 2mg Tablets INN or Proposed INN: DEXAMETHASONE Trade Name: Prednisolone 1mg Tablets INN or Proposed INN: Prednisolone Other descriptive name: PREDNISOLONE | Diurnal Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 3 | France;United States;Denmark;Netherlands;Germany;United Kingdom;Sweden | ||
| 13 | EUCTR2015-000711-40-GB (EUCTR) | 19/11/2015 | 28/07/2015 | 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. | A Phase III study of efficacy, safety and tolerability of Chronocort® compared with standard glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia. | 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] | Diurnal Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 3 | France;United States;Denmark;Netherlands;Germany;United Kingdom;Sweden | |||
| 14 | EUCTR2015-000458-40-DE (EUCTR) | 20/10/2015 | 21/08/2015 | Open-label, long-term follow-up of safety and biochemical disease control of Infacort® in neonates, infants and children with congenital adrenal hyperplasia and adrenal insufficiency previously enrolled in the Infacort 003 study | Open-label, long-term follow-up of safety and biochemical disease control of Infacort® in neonates, infants and children with congenital adrenal hyperplasia and adrenal insufficiency previously enrolled in the Infacort 003 study - Infacort004 | Adrenal Insufficiency (AI) in children is most commonly due to Congenital Adrenal Hyperplasia (CAH) and results in cortisol deficiency with or without aldosterone deficiency and androgen excess. Current standard treatment in neonates is unsatisfactory, as unlicensed and crushed adult dosage formulations (Hydrocortisone tablets,10 mg) are used. Infacort® is a new paediatric and neonatal formulation of hydrocortisone that is provided in appropriate unit dosage (0.5mg, 1.0mg, 2.0mg and 5mg);Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Diurnal Limited | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 3 | Germany | |||
| 15 | EUCTR2014-002265-30-DE (EUCTR) | 19/02/2015 | 23/12/2014 | A Phase 3 open-label study of Infacort® in neonates, infants and children less than 6 years of age with adrenal insufficiency. | A Phase 3 open-label study of Infacort® in neonates, infants and children less than 6 years of age with adrenal insufficiency. | Adrenal Insufficiency (AI) in children is most commonly due to Congenital Adrenal Hyperplasia (CAH) and results in cortisol deficiency with or without aldosterone deficiency and androgen excess. Current standard treatment in neonates is unsatisfactory, as unlicensed and crushed adult dosage formulations (Hydrocortisone tablets, 10 mg) are used. Infacort® is a new paediatric and neonatal formulation of hydrocortisone that is provided in appropriate unit dosage (0.5mg, 1.0mg, 2.0mg and 5mg).;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: infacort INN or Proposed INN: infacort Other descriptive name: HYDROCORTISONE Product Name: infacort INN or Proposed INN: infacort Other descriptive name: HYDROCORTISONE Product Name: infacort INN or Proposed INN: infacort Other descriptive name: HYDROCORTISONE Product Name: infacort INN or Proposed INN: infacort Other descriptive name: HYDROCORTISONE | Diurnal Limited | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | Germany | |||
| 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 |
| 16 | EUCTR2011-005822-23-SE (EUCTR) | 18/11/2014 | 20/09/2013 | A trial comparing continuous subcutaneous hydrocortisone infusion (CSHI) therapy with conventional oral glucocorticoid therapy in patients with Congenital Andrenal Hyperplasia (CAH) | CONTINUOUS SUBCUTANEOUS HYDROCORTISONE INFUSION IN CONGENITAL ADRENAL HYPERPLASIA | Congenital Adrenal Hyperplasia MedDRA version: 14.1;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Solu-Cortef INN or Proposed INN: HYDROCORTISONE SODIUM SUCCINATE Other descriptive name: HYDROCORTISONE SODIUM SUCCINATE INN or Proposed INN: Prednisolone INN or Proposed INN: Hydrocortisone | Haukeland University Hospital | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | Norway;Sweden | ||
| 17 | EUCTR2012-001104-37-GB (EUCTR) | 06/10/2014 | 24/07/2014 | pulses study | Pulsed glucocorticoid replacement therapy for patients with adrenocortical insufficiency secondary to Addison’s disease and congenital adrenal hyperplasia - the pulses study | Addison's disease and Congenital Adrenal Hyperplasia MedDRA version: 17.0;Level: LLT;Classification code 10011195;Term: Cortisol;System Organ Class: 100000004848 MedDRA version: 17.0;Classification code 10020518;Term: Hydrocortisone;System Organ Class: 100000004848;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: hydrocortisone sodium phosphate Product Name: hydrocortisone sodium phosphate INN or Proposed INN: hydrocortisone sodium phosphate Trade Name: hydrocortisone Product Name: hydrocortisone INN or Proposed INN: hydrocortisone | University Hospitals Bristol NHS Foundation Trust | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | United Kingdom | ||||
| 18 | NCT02096510 (ClinicalTrials.gov) | August 2014 | 28/11/2013 | Ultradian Subcutaneous Hydrocortisone Infusion in Addison Disease and Congenital Adrenal Hyperplasia | Ultradian Subcutaneous Hydrocortisone Infusion in Addison Disease and Congenital Adrenal Hyperplasia | Addison Disease;Adrenal Hyperplasia Congenital | Drug: Solu-Cortef;Drug: Cortef | Haukeland University Hospital | NULL | Recruiting | 18 Years | 65 Years | Both | 10 | Phase 1;Phase 2 | Norway |
| 19 | NCT01859312 (ClinicalTrials.gov) | May 6, 2013 | 17/5/2013 | Comparison of Cortisol Pump With Standard Treatment for Congenital Adrenal Hyperplasia | A Pilot Study Assessing the Use of Continuous Subcutaneous Hydrocortisone Infusion in the Treatment of Congenital Adrenal Hyperplasia | Adrenal Insufficiency;Excess Androgen;Congenital Adrenal Hyperplasia (CAH) | Drug: Hydrocortisone (Solucortef);Device: Insulin pump (Medtronic) | National Institutes of Health Clinical Center (CC) | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Completed | 18 Years | 99 Years | All | 8 | Phase 2 | United States |
| 20 | NCT01771328 (ClinicalTrials.gov) | February 2013 | 10/1/2013 | Continuous Subcutaneous Hydrocortisone Infusion in Congenital Adrenal Hyperplasia | Continuous Subcutaneous Hydrocortisone Infusion in Congenital Adrenal Hyperplasia | Adrenal Hyperplasia, Congenital | Drug: Hydrocortisone;Drug: Cortisone acetate | Haukeland University Hospital | NULL | Recruiting | 18 Years | 60 Years | Both | 20 | Phase 2 | Norway |
| 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 |
| 21 | NCT01735617 (ClinicalTrials.gov) | December 2012 | 20/11/2012 | Pilot Study to Characterize and Examine the Pharmacokinetics and Efficacy of Chronocort® in Adults With CAH | A Phase 2 Pilot Study to Characterize and Examine the Pharmacokinetics and Disease Bio-marker Response of Chronocort® in Adults With Congenital Adrenal Hyperplasia | Endocrine Disease;Adrenal Insufficiency;Congenital Adrenal Hyperplasia | Drug: Hydrocortisone Modified Release Capsules | Diurnal Limited | National Institutes of Health (NIH) | Completed | 18 Years | N/A | All | 16 | Phase 2 | United States |
| 22 | EUCTR2011-005822-23-NO (EUCTR) | 16/10/2012 | 25/02/2013 | A trial comparing continuous subcutaneous hydrocortisone therapy with conventional oral glucocorticoid therapy in congenital adrenal hyperplasia | CONTINUOUS SUBCUTANEOUS HYDROCORTISONE INFUSION IN CONGENITAL ADRENAL HYPERPLASIA | Congenital adrenal hyperplasia (CAH) MedDRA version: 14.1;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Solu-Cortef Trade Name: Cortison Trade Name: Prednisolone | Haukeland University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Norway | ||||
| 23 | NCT03019614 (ClinicalTrials.gov) | March 2010 | 11/1/2017 | An Open Label Study in Healthy Volunteers to Compare Chronocort® to Hydrocortisone | An Open Label, Randomised, Single Dose, 3-period Crossover Study in Healthy Volunteers to: a) Compare the Pharmacokinetics of Chronocort® Formulations Versus Immediate Release Hydrocortisone, and (b) Determine the Dose Proportionality of Chronocort® Formulations | Congenital Adrenal Hyperplasia;Adrenal Insufficiency | Drug: Hydrocortisone;Drug: Chronocort | Diurnal Limited | Simbec Research | Completed | 18 Years | 60 Years | Male | 30 | Phase 1 | NULL |
| 24 | NCT00621985 (ClinicalTrials.gov) | April 2008 | 11/2/2008 | Dexamethasone Treatment of Congenital Adrenal Hyperplasia | Dexamethasone Treatment of Congenital Adrenal Hyperplasia | Adrenal Hyperplasia, Congenital | Drug: dexamethasone;Drug: Hydrocortisone | Boston Children’s Hospital | NULL | Completed | 2 Years | 9 Years | All | 5 | Phase 2 | United States |
| 25 | NCT00519818 (ClinicalTrials.gov) | August 2007 | 22/8/2007 | Comparison of Two Forms of Hydrocortisone in Patients With Congenital Adrenal Hyperplasia | A Phase 2, Open Label, Crossover Pharmacokinetic and Pharmacodynamic Study to Compare Chronocort Versus Cortef in Patients With CAH | Congenital Adrenal Hyperplasia;21-Hydroxylase Deficiency;Adrenogenital Syndrome | Drug: Chronocort;Drug: Cortef | Diurnal Limited | National Institutes of Health Clinical Center (CC) | Completed | 16 Years | 60 Years | All | 20 | Phase 1;Phase 2 | United States |
| 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 |
| 26 | NCT00542841 (ClinicalTrials.gov) | August 2007 | 10/10/2007 | Examining Genetic Differences Among People With 21-Hydroxylase Deficiency | Modifier Genes in 21-Hydroxylase Deficiency | 21-hydroxylase Deficiency | Procedure: Hydrocortisone withdrawal | Maria I. New | Office of Rare Diseases (ORD);National Center for Research Resources (NCRR) | Completed | 18 Years | 50 Years | Both | 99 | N/A | United States;Brazil;France |
| 27 | NCT00529841 (ClinicalTrials.gov) | January 2007 | 12/9/2007 | Research Study for Children With Salt Wasting Congenital Adrenal Hyperplasia | A Novel Therapeutic Modality for Congenital Adrenal Hyperplasia | Adrenal Hyperplasia, Congenital | Drug: Hydrocortisone sodium acetate | Baylor College of Medicine | NULL | Completed | 3 Years | 18 Years | Both | 7 | N/A | United States |
| 28 | NCT00001521 (ClinicalTrials.gov) | June 8, 1995 | 3/11/1999 | Three Drug Combination Therapy Versus Conventional Treatment of Children With Congenital Adrenal Hyperplasia | An Open, Randomized, Long-Term Clinical Trial of Flutamide, Testolactone, and Reduced Hydrocortisone Dose vs. Conventional Treatment of Children With Congenital Adrenal Hyperplasia | Congenital Adrenal Hyperplasia (CAH) | Drug: Flutamide;Drug: Letrozole;Drug: Hydrocortisone;Drug: Fludrocortisone | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NULL | Active, not recruiting | 2 Years | 18 Years | All | 62 | Phase 2 | United States |
| 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 | EUCTR2015-001090-40-GB (EUCTR) | 22/06/2015 | 08/04/2015 | The effects of two brands of hydrocortisone injected intramuscularly into deltoid and thigh muscles | An open label pilot study to investigate the effects of two preparations of hydrocortisone (Hydrocortisone 100mg/ml and Solu-Cortef) injected intramuscularly into the deltoid and upper thigh muscle during the state of hypocortisolaemia - Effects of 100mg Hydrocortisone injection into Deltoid & Thigh | Addison's Disease MedDRA version: 20.1;Level: PT;Classification code 10001130;Term: Addison's disease;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Trade Name: Solu-Cortef Product Name: Solu-Cortef INN or Proposed INN: Hydrocortisone Trade Name: Hydrocortisone 100mg/ml Product Name: Hydrocortisone 100mg/ml INN or Proposed INN: Hydrocortisone | The London Clinic | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 8 | Phase 4 | United Kingdom | ||
| 2 | EUCTR2012-001104-37-GB (EUCTR) | 06/10/2014 | 24/07/2014 | pulses study | Pulsed glucocorticoid replacement therapy for patients with adrenocortical insufficiency secondary to Addison’s disease and congenital adrenal hyperplasia - the pulses study | Addison's disease and Congenital Adrenal Hyperplasia MedDRA version: 17.0;Level: LLT;Classification code 10011195;Term: Cortisol;System Organ Class: 100000004848 MedDRA version: 17.0;Classification code 10020518;Term: Hydrocortisone;System Organ Class: 100000004848;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: hydrocortisone sodium phosphate Product Name: hydrocortisone sodium phosphate INN or Proposed INN: hydrocortisone sodium phosphate Trade Name: hydrocortisone Product Name: hydrocortisone INN or Proposed INN: hydrocortisone | University Hospitals Bristol NHS Foundation Trust | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | United Kingdom | ||||
| 3 | NCT02096510 (ClinicalTrials.gov) | August 2014 | 28/11/2013 | Ultradian Subcutaneous Hydrocortisone Infusion in Addison Disease and Congenital Adrenal Hyperplasia | Ultradian Subcutaneous Hydrocortisone Infusion in Addison Disease and Congenital Adrenal Hyperplasia | Addison Disease;Adrenal Hyperplasia Congenital | Drug: Solu-Cortef;Drug: Cortef | Haukeland University Hospital | NULL | Recruiting | 18 Years | 65 Years | Both | 10 | Phase 1;Phase 2 | Norway |
| 4 | NCT02152553 (ClinicalTrials.gov) | May 2014 | 12/5/2014 | Biomarker(s) for Glucocorticoids | Protein/Metabolite Biomarker(s) for Glucocorticoid Action; an Experimental Trial in Patients With Adrenal Insufficiency | Addison Disease | Drug: Hydrocortisone;Drug: Placebo | Vastra Gotaland Region | NULL | Completed | 20 Years | 60 Years | All | 11 | N/A | Sweden |
| 5 | EUCTR2013-004189-33-NO (EUCTR) | 28/11/2013 | 30/10/2013 | A trial comparing continuous subcutaneous hydrocortisone therapy with pulsatile subcutaneous hydrocortisone therapy in patients with Addison`s disease | ULTRADIAN SUBCUTANEOUS HYDROCORTISONE (USHI) INFUSION IN ADDISON’S DISEASE | Addison`s disease;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Solu-Cortef Trade Name: Cortef 5 mg | Haukeland University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 10 | Norway | |||
| 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 |
| 6 | NCT01847690 (ClinicalTrials.gov) | June 2013 | 23/4/2013 | Effect of Cortisol on Physical Exertion in Patients With Primary Adrenal Failure | Effect of Cortisol on Physical Exertion in Patients With Primary Adrenal | Addison Disease | Drug: Hydrocortisone | Haukeland University Hospital | NULL | Active, not recruiting | 18 Years | 70 Years | Female | 20 | Phase 2 | Norway |
| 7 | EUCTR2011-002687-25-DE (EUCTR) | 16/11/2011 | 06/10/2011 | Evaluation of the time to cortisol levels required in critical illness (>1000 nmol/l) and safety of hydrocortisone, after subcutaneous injection in patients with chronic primary adrenal insufficiency(Comparison s.c. vs. i.m.) | Pharmacokinetics of Hydrocortisone after Subcutaneous Administration Compared with Intramuscular Injection in Chronic Adrenal Insufficiency(PHYSCA-Trial) - PHYSCA- Trial | Adrenal insufficiency under chronic glucocorticoid replacement MedDRA version: 14.0;Level: PT;Classification code 10001130;Term: Addison's disease;System Organ Class: 10014698 - Endocrine disorders MedDRA version: 14.0;Classification code 10052381;Term: Primary adrenal insufficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Hydrocortison 100 mg (Pfizer®) in 2 ml solvent INN or Proposed INN: Hydrocortisone Other descriptive name: HYDROCORTISONE HYDROGEN SUCCINATE | University Hospital of Wuerzburg | NULL | Not Recruiting | Female: yes Male: yes | 12 | Germany | |||
| 8 | EUCTR2009-010917-61-SE (EUCTR) | 25/08/2010 | 05/07/2010 | Glucocorticoid Replacement in Addison's disease | Glucocorticoid Replacement in Addison's disease | Autoimmune Addison's disease is a rare and chronic disease wich leads to primary adrenal failure. The conventional glucocorticoid replacement therapy in primary adrenal insufficiency (Addison’s disease) renders the cortisol levels unphysiological, which may cause symptoms and long-term complications. In this study we will include patients with Addison's disease to explore if more physiological glucocorticoid treatment could improve health for the patients. MedDRA version: 9.1;Level: LLT;Classification code 10001130;Term: Addison's disease | Trade Name: Solu-Cortef INN or Proposed INN: HYDROCORTISONE SODIUM SUCCINATE Product Name: Hydrokortison APL kapsel 2,5 mg INN or Proposed INN: Hydrocortisonum | Haukeland University hospital | NULL | Not Recruiting | Female: yes Male: yes | 40 | Sweden | |||
| 9 | NCT01063569 (ClinicalTrials.gov) | February 2010 | 26/1/2010 | Glucocorticoid Treatment in Addison's Disease | Glucocorticoid Treatment in Addison's Disease | Addison's Disease | Drug: Solu-Cortef (hydrocortisone);Drug: Cortef (hydrocortisone) | Haukeland University Hospital | NULL | Completed | 18 Years | 70 Years | Both | 33 | Phase 2;Phase 3 | Norway;Sweden |
| 10 | EUCTR2007-005170-30-FR (EUCTR) | 08/12/2007 | 25/10/2007 | Pharmacocinétique de l’Hydrocortisone chez le patient ADdisonien : évaluation de la valeur prédictive de l’ACTH plasmatique pour la titration du traitement substitutif - PHAD | Pharmacocinétique de l’Hydrocortisone chez le patient ADdisonien : évaluation de la valeur prédictive de l’ACTH plasmatique pour la titration du traitement substitutif - PHAD | ADDISON'S DISEASE MedDRA version: 9.1;Level: LLT;Classification code 10001130;Term: Addison's disease | Trade Name: hydrocortisone Roussel Product Name: HYDROCORTISONE ROUSSEL | CHU CAEN | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 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 |
| 11 | EUCTR2005-001768-30-SE (EUCTR) | 04/01/2006 | 07/12/2005 | Comparison of 2 and 4 doses hydrocortison substitution with regard to plasma concentration and quality of life. - CHEQ | Comparison of 2 and 4 doses hydrocortison substitution with regard to plasma concentration and quality of life. - CHEQ | We aim to study patients with cortisol deficiency caused by primary adrenal insufficiency (Addison’s disease of autoimmune origin). | Product Name: Hydrocortisone | EM-kliniken | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Sweden | |||
| 12 | NCT00688987 (ClinicalTrials.gov) | August 2000 | 30/5/2008 | The Hypothalamic-Pituitary-Adrenal (HPA) Axis as an Effector System in Weight Regulation | Cortisol, Central Obesity, and Insulin Resistance: Long Term Studies in Addison's Patients | Obesity;Addison's Disease | Drug: Hydrocortisone;Dietary Supplement: Isocaloric Diet | Oregon Health and Science University | NULL | Completed | 18 Years | N/A | Both | 24 | N/A | United States |
| 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 | NCT04469686 (ClinicalTrials.gov) | July 30, 2020 | 2/7/2020 | Phase 3 Study to Evaluate the Safety and Efficacy of Hydrocortisone Acetate Suppositories | 3-Arm Randomized Placebo Controlled Double Blind Phase 3 Study to Evaluate Safety and Efficacy of Once-Daily and Twice-Daily Hydrocortisone Acetate 90 mg Suppository Administered With a Sephure Applicator in Subjects With Ulcerative Colitis | Ulcerative Proctitis | Combination Product: Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator;Combination Product: Once daily 90 mg hydrocortisone acetate or placebo suppository administered with Sephure applicator;Combination Product: Twice daily placebo suppository administered with Sephure applicator | Cristcot LLC | Cristcot HCA LLC | Recruiting | 18 Years | N/A | All | 618 | Phase 3 | United States |
| 2 | EUCTR2019-003596-19-DE (EUCTR) | 29/07/2020 | 29/07/2020 | A Three-Arm, Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Safety and Efficacy of Once-Daily and Twice-Daily Dosing of a Novel Hydrocortisone Acetate 90 mg Suppository Formulation Administered with the Sephure® Suppository Applicator in Subjects with Ulcerative Colitis of the Rectum. | A Three-Arm, Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Safety and Efficacy of Once-Daily and Twice-Daily Dosing of a Novel Hydrocortisone Acetate 90 mg Suppository Formulation Administered with the Sephure® Suppository Applicator in Subjects with Ulcerative Colitis of the Rectum. - cessa | Ulcerative Colitis of the Rectum MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;Level: HLT;Classification code 10027682;Term: Immune and associated conditions NEC;System Organ Class: 10021428 - Immune system disorders MedDRA version: 20.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;Level: HLGT;Classification code 10027665;Term: Immune disorders NEC;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 90 mg hydrocortisone acetate suppository with Sephure suppository applicator INN or Proposed INN: HYDROCORTISONE ACETATE | Cristcot HCA LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 618 | Phase 3 | United States;Philippines;Hong Kong;Spain;Poland;Ukraine;Romania;Russian Federation;Germany;Italy;India | ||
| 3 | NCT03110198 (ClinicalTrials.gov) | May 2017 | 19/2/2017 | Mesalazine With Hydrocortisone Sodium Succinate Enema for 4-Week Treatment in Patients With Ulcerative Colitis | A Randomized, Double-blind Study Investigating the Efficacy and Safety of Mesalazine With Hydrocortisone Sodium Succinate (100mg QD) Enema for 4-Week Treatment in Patients With Ulcerative Colitis (UC) | Ulcerative Colitis, Unspecified | Drug: Mesalazine;Drug: hydrocortisone sodium succinate;Drug: Mesalazine with hydrocortisone sodium succinate | Xijing Hospital of Digestive Diseases | Shanghai Tongji Hospital, Tongji University School of Medicine;First Affiliated Hospital of Zhongshan Medical University | Recruiting | 18 Years | 70 Years | All | 528 | Phase 4 | China |
| 4 | NCT02425852 (ClinicalTrials.gov) | December 2016 | 21/4/2015 | A Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus IFX to Steroids Plus Azathioprine for Acute Severe Colitis | A Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus Infliximab to Corticosteroids Plus Azathioprine for Acute Severe Colitis | Ulcerative Colitis | Drug: Azathioprine;Drug: Infliximab;Drug: Prednisolone;Drug: Hydrocortisone | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | NULL | Recruiting | 18 Years | N/A | All | 146 | Phase 4 | France |
| 5 | NCT00805285 (ClinicalTrials.gov) | October 2008 | 8/12/2008 | The Use of Oral Budesonide and Rectal Hydrocortisone for the Treatment of Active Ulcerative Colitis | Oral Budesonide and Rectal Hydrocortisone for the Treatment of Extensive Ulcerative Colitis: A Pilot Study | Inflammatory Bowel Disease;Ulcerative Colitis | Drug: Combination Oral Budesonide and Rectal Hydrocortisone | University of Maryland, Baltimore | NULL | Terminated | 18 Years | N/A | All | 1 | Phase 2 | United States |
| 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 | EUCTR2011-005790-23-GB (EUCTR) | 17/07/2012 | 06/06/2012 | Comparison of recovery of adrenal gland function following short and long term steroid treatment | Comparison of adrenal recovery following short and long-term glucocorticoid therapy. - Adrenal recovery following short and long-term glucocorticoid therapy | Adrenal recovery following long and short term steroid treatment. MedDRA version: 14.1;Level: LLT;Classification code 10066550;Term: Chronic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.1;Classification code 10000842;Term: Acute lymphatic leukaemia;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1;Classification code 10008953;Term: Chronic liver disease;System Organ Class: 10019805 - Hepatobiliary disorders MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Physiological processes [G07] | Product Name: Prednisolone INN or Proposed INN: Prednisolone Product Name: Hydrocortisone INN or Proposed INN: Hydrocortisone | Birmingham Children's Hospital NHS Foundation Trust | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | United Kingdom |