83. Addison disease Clinical trials / Disease details
Clinical trials : 20 / Drugs : 39 - (DrugBank : 13) / Drug target genes : 6 - Drug target pathways : 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 | 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 | ||
| 3 | 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 | ||||
| 4 | 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 |
| 5 | 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 |
| 6 | 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 | |||
| 7 | 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 |
| 8 | 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 | |||
| 9 | 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 | |||
| 10 | 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 |
| 11 | 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 | ||
| 12 | 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 | |||
| 13 | 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 |