DDrare: Database of Drug Development for Rare Diseases

83. Addison disease
[ 17 clinical trials, 27 drugs（DrugBank: 13 drugs), 6 target genes / 17 target pathways ]

Searched query = "Addison disease", "Primary chronic adrenocortical insufficiency", "Autoimmune polyglandular syndrome", "Hypoparathyroidism Addison Monilia syndrome", "HAM syndrome", "Schmidt syndrome"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/20/2019, 11/21/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.

Drug = Acetate; Cortef; Cortef (hydrocortisone); Cortef 5 mg; Cosyntropin; Dehydroepiandrosterone; Dexamethasone; Efcortesol; Grapefruit; Grapefruit juice; Hydrocortisone; Hydrocortisone efcortesol & solu-cortef; Hydrocortisone roussel; Hydrocortisone sodium phosphate; Isocaloric diet; Liquorice; Mabthera; Mabthera infusion; Methylprednisolone; Phosphate; Rituximab; Solu-cortef; Solu-cortef (hydrocortisone); Solu-medrone; Synacthen depot; Tetracosactide; Tetracosactide acetate

No.	TrialID	Date_ enrollement	Last_Refreshed_ on	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT03210545	September 1, 2019	12 November 2018	A Study of Markers of Glucocorticoid Effects in Patients With Addisons Disease (DOSCORT)	A Dose-response Study of Markers of Glucocorticoid Effects (DOSCORT): A Single-blinded, Randomized, 2-dose, Cross-over Study	Addison Disease	Drug: Dexamethasone	Göteborg University		Not recruiting	20 Years	60 Years	All	30	Phase 4	Sweden
2	NCT03793114	September 26, 2018	27 May 2019	Screening and Stimulation Testing for Residual Secretion of Adrenal Steroid Hormones in Autoimmune Addison's Disease	Residual Secretion of Adrenal Steroid Hormones in Addison's Disease	Primary Adrenal Insufficiency	Diagnostic Test: Cosyntropin stimulation test;Diagnostic Test: Baseline blood tests;Device: 30-hour ambulatory sampling of intestinal fluid	University of Bergen	Karolinska Institutet;Charite University, Berlin, Germany	Recruiting	18 Years	70 Years	All	200	N/A	Germany;Norway;Sweden
3	EUCTR2015-001090-40-GB	22/06/2015	28 September 2015	Effects of hydrocortisone injection into deltoid and thigh muscles	An Open Label, Non-Randomised study to investigate the effects of 100mg Intramascular Hydrocortisone Injection in the Deltoid and Upper Thigh Muscle during the state of hypocortisolaemia - Effects of 100mg Hydrocortisone inj into Deltoid & Thigh	Addison's Disease;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]	Trade Name: Efcortesol Product Name: Hydrocortisone Efcortesol & Solu-Cortef Pharmaceutical Form: Injection	The London Clinic		Authorised			Female: yes Male: yes	8		United Kingdom
4	EUCTR2012-001104-37-GB	06/10/2014	23 March 2015	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 Level: LLT 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 Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: hydrocortisone sodium phosphate CAS Number: 6000 74 4 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Solution for injection/infusion Route of administration of the placebo: Subcutaneous use Trade Name: hydrocortisone Product Name: hydrocortisone Pharmaceutical Form: Capsule INN or Proposed INN: hydrocortisone CAS Number: 50-23-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use	University Hospitals Bristol NHS Foundation Trust		Authorised			Female: yes Male: yes			United Kingdom
5	NCT02096510	August 2014	9 January 2017	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		Recruiting	18 Years	65 Years	Both	10	Phase 1/Phase 2	Norway
No.	TrialID	Date_ enrollement	Last_Refreshed_ on	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	NCT02152553	May 2014	13 May 2019	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		Not recruiting	20 Years	60 Years	All	11	N/A	Sweden
7	EUCTR2013-004189-33-NO	28/11/2013	28 April 2014	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 Pharmaceutical Form: Powder and solvent for solution for infusion Trade Name: Cortef 5 mg Pharmaceutical Form: Tablet	Haukeland University Hospital		Authorised			Female: yes Male: yes	10		Norway
8	NCT01847690	June 2013	19 February 2015	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		Not recruiting	18 Years	70 Years	Female	20	Phase 2	Norway
9	EUCTR2012-001682-33-GB	06/09/2012	30 April 2019	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 System Organ Class: 10014698 - Endocrine disorders MedDRA version: 16.1 Level: LLT 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 Pharmaceutical Form: Concentrate for solution for infusion Trade Name: Solu-Medrone Product Name: Solu-Medrone Product Code: Methylprednisolone Pharmaceutical Form: Powder for injection Trade Name: Synacthen Depot Product Name: Synacthen Depot Product Code: Tetracosactide acetate Pharmaceutical Form: Suspension for injection	Newcastle upon Tyne Hospitals NHS Foundation Trust		Not Recruiting			Female: yes Male: yes	30	Phase 2	United Kingdom
10	EUCTR2009-018074-56-GB	05/05/2010	3 December 2012	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 Pharmaceutical Form: Suspension for injection	Newcastle upon Tyne Hospitals NHS Foundation Trust		Not Recruiting			Female: yes Male: yes	12		United Kingdom
No.	TrialID	Date_ enrollement	Last_Refreshed_ on	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
11	NCT01063569	February 2010	19 February 2015	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		Not recruiting	18 Years	70 Years	Both	33	Phase 2/Phase 3	Norway;Sweden
12	EUCTR2007-003062-18-GB	05/06/2008	19 March 2012	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 Pharmaceutical Form: Concentrate for solution for infusion Trade Name: Solu-medrone Product Name: Solu-medrone Pharmaceutical Form: Powder for injection*	Newcastle upon Tyne Hospitals NHS Trust		Authorised			Female: yes Male: yes	10		United Kingdom
13	NCT01271296	April 2008	19 February 2015	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		Not recruiting	18 Years	80 Years	Both	17	N/A	Norway
14	EUCTR2007-005170-30-FR	08/12/2007	19 March 2012	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 Pharmaceutical Form: Tablet	CHU CAEN		Authorised			Female: yes Male: yes			France
15	EUCTR2005-001768-30-SE	04/01/2006	19 March 2012	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 Pharmaceutical Form: Capsule* Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use	EM-kliniken		Authorised			Female: yes Male: yes	12		Sweden
No.	TrialID	Date_ enrollement	Last_Refreshed_ on	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
16	NCT00688987	August 2000	19 February 2015	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		Not recruiting	18 Years	N/A	Both	24	N/A	United States
17	NCT00004313	August 1995	19 February 2015	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	Not recruiting	18 Years	N/A	Both	40	Phase 3