83. アジソン病 Addison disease Clinical trials / Disease details
臨床試験数 : 20 / 薬物数 : 39 - (DrugBank : 13) / 標的遺伝子数 : 6 - 標的パスウェイ数 : 18
| 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 | NCT05350020 (ClinicalTrials.gov) | March 14, 2022 | 29/3/2022 | 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 | Addison's Disease | Drug: Solu-Cortef 100 MG Injection;Drug: Hydrocortisone 100mg/ml | The London Clinic | NULL | Recruiting | 18 Years | 70 Years | All | 8 | Phase 4 | United Kingdom |
| 2 | NCT03210545 (ClinicalTrials.gov) | March 2, 2021 | 29/6/2017 | A Study of Markers of Glucocorticoid Effects in Patients With Addisons Disease (DOSCORT) | A Dose-response Study of Markers of Glucocorticoid Effects (DOSCORT): A Double-blinded, Randomized, 2-dose, Cross-over Study | Addison Disease | Drug: Betamethasone | Göteborg University | NULL | Recruiting | 20 Years | 65 Years | All | 30 | Phase 4 | Sweden |
| 3 | 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 | ||
| 4 | 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 | ||||
| 5 | 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 |
| 6 | 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 |
| 7 | 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 | |||
| 8 | 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 |
| 9 | EUCTR2012-001682-33-GB (EUCTR) | 06/09/2012 | 15/06/2012 | Rescue of Addison’s disease 2 | Combined Immunotherapy and Trophic Adrenocortical Stimulation in New Onset Autoimmune Addison’s Disease - Rescue of Addison’s disease 2 (RADS2) | Autoimmune Addison's disease: autoimmune primary adrenal insufficiency MedDRA version: 16.1;Level: PT;Classification code 10052381;Term: Primary adrenal insufficiency;System Organ Class: 10014698 - Endocrine disorders MedDRA version: 16.1;Level: LLT;Classification code 10001335;Term: Adrenal cortex insufficiency;Classification code 10001342;Term: Adrenal cortical hypofunction;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Mabthera infusion Product Name: Mabthera Infusion Product Code: Rituximab Trade Name: Solu-Medrone Product Name: Solu-Medrone Product Code: Methylprednisolone Trade Name: Synacthen Depot Product Name: Synacthen Depot Product Code: Tetracosactide acetate | Newcastle upon Tyne Hospitals NHS Foundation Trust | NULL | Not Recruiting | Female: yes Male: yes | 30 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 10 | 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 | |||
| 11 | NCT01371526 (ClinicalTrials.gov) | September 2010 | 9/3/2011 | Revival of Stem Cells in Addison's Study | Revival of Autochthonous Adrenocortical Stem Cells in Autoimmune Addison's Disease | Adrenal Failure | Drug: depot tetracosactide | Newcastle University | NULL | Completed | 16 Years | 66 Years | Both | 13 | Phase 4 | United Kingdom |
| 12 | 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 | |||
| 13 | EUCTR2009-018074-56-GB (EUCTR) | 05/05/2010 | 18/03/2010 | Revival of autochthonous adrenocortical stem cells in autoimmune Addison’s disease (RoSA) - Revival of Stem cells in Addison's disease (RoSA) | Revival of autochthonous adrenocortical stem cells in autoimmune Addison’s disease (RoSA) - Revival of Stem cells in Addison's disease (RoSA) | Autoimmune Addison's disease MedDRA version: 9.1;Level: HLT;Classification code 10001343;Term: Adrenal cortical hypofunction | Trade Name: Synacthen Depot Product Name: Synacthen Depot | Newcastle upon Tyne Hospitals NHS Foundation Trust | NULL | Not Recruiting | Female: yes Male: yes | 12 | United Kingdom | |||
| 14 | 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 |
| 15 | EUCTR2007-003062-18-GB (EUCTR) | 05/06/2008 | 15/02/2008 | Immunotherapeutic Rescue of steroidogenic function in autoimmune Addison’s Disease (RAD): Pilot study - Rescue of Addison's Disease (RAD) | Immunotherapeutic Rescue of steroidogenic function in autoimmune Addison’s Disease (RAD): Pilot study - Rescue of Addison's Disease (RAD) | Autoimmune Addison's disease (adrenocortical failure) MedDRA version: 9.1;Level: HLT;Classification code 10001343;Term: Adrenal cortical hypofunctions | Trade Name: MabThera Product Name: MabThera Trade Name: Solu-medrone Product Name: Solu-medrone | Newcastle upon Tyne Hospitals NHS Trust | NULL | Not Recruiting | Female: yes Male: yes | 10 | Phase 4 | United Kingdom | ||
| 16 | NCT01271296 (ClinicalTrials.gov) | April 2008 | 22/12/2010 | Effects and Interactions of Liquorice and Grapefruit on Glucocorticoid Replacement Therapy in Addison's Disease | Use of Liquorice and Grapefruit in Patients With Addison's Disease | Addison Disease | Dietary Supplement: Liquorice;Dietary Supplement: Grapefruit Juice | Haukeland University Hospital | NULL | Completed | 18 Years | 80 Years | Both | 17 | N/A | Norway |
| 17 | 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 | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | France | ||
| 18 | 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 | |||
| 19 | 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 |
| 20 | NCT00004313 (ClinicalTrials.gov) | August 1995 | 18/10/1999 | Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone Replacement for Primary Adrenal Insufficiency | Addison's Disease | Drug: dehydroepiandrosterone | National Center for Research Resources (NCRR) | University of California, Los Angeles | Completed | 18 Years | N/A | Both | 40 | Phase 3 | NULL |