83. Addison disease Clinical trials / Disease details


Clinical trials : 20 Drugs : 43 - (DrugBank : 13) / Drug target genes : 6 - Drug target pathways : 18

  
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1NCT03210545
(ClinicalTrials.gov)
March 2, 202129/6/2017A 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 StudyAddison DiseaseDrug: BetamethasoneGöteborg UniversityNULLRecruiting20 Years65 YearsAll30Phase 4Sweden
2NCT03793114
(ClinicalTrials.gov)
September 26, 20186/11/2018Screening and Stimulation Testing for Residual Secretion of Adrenal Steroid Hormones in Autoimmune Addison's DiseaseResidual Secretion of Adrenal Steroid Hormones in Addison's DiseasePrimary Adrenal InsufficiencyDiagnostic Test: Cosyntropin stimulation test;Diagnostic Test: Baseline blood tests;Device: 30-hour ambulatory sampling of intestinal fluid;Other: Blood testUniversity of BergenKarolinska Institutet;Charite University, Berlin, GermanyActive, not recruiting18 Years70 YearsAll200N/AGermany;Norway;Sweden
3EUCTR2015-001090-40-GB
(EUCTR)
22/06/201508/04/2015The effects of two brands of hydrocortisone injected intramuscularly into deltoid and thigh musclesAn 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 ClinicNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
8Phase 4United Kingdom
4EUCTR2012-001104-37-GB
(EUCTR)
06/10/201424/07/2014pulses studyPulsed 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 TrustNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
United Kingdom
5NCT02096510
(ClinicalTrials.gov)
August 201428/11/2013Ultradian Subcutaneous Hydrocortisone Infusion in Addison Disease and Congenital Adrenal HyperplasiaUltradian Subcutaneous Hydrocortisone Infusion in Addison Disease and Congenital Adrenal HyperplasiaAddison Disease;Adrenal Hyperplasia CongenitalDrug: Solu-Cortef;Drug: CortefHaukeland University HospitalNULLRecruiting18 Years65 YearsBoth10Phase 1/Phase 2Norway
6NCT02152553
(ClinicalTrials.gov)
May 201412/5/2014Biomarker(s) for GlucocorticoidsProtein/Metabolite Biomarker(s) for Glucocorticoid Action; an Experimental Trial in Patients With Adrenal InsufficiencyAddison DiseaseDrug: Hydrocortisone;Drug: PlaceboVastra Gotaland RegionNULLCompleted20 Years60 YearsAll11N/ASweden
7EUCTR2013-004189-33-NO
(EUCTR)
28/11/201330/10/2013A trial comparing continuous subcutaneous hydrocortisone therapy with pulsatile subcutaneous hydrocortisone therapy in patients with Addison`s diseaseULTRADIAN 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 HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
10Norway
8NCT01847690
(ClinicalTrials.gov)
June 201323/4/2013Effect of Cortisol on Physical Exertion in Patients With Primary Adrenal FailureEffect of Cortisol on Physical Exertion in Patients With Primary AdrenalAddison DiseaseDrug: HydrocortisoneHaukeland University HospitalNULLActive, not recruiting18 Years70 YearsFemale20Phase 2Norway
9EUCTR2012-001682-33-GB
(EUCTR)
06/09/201215/06/2012Rescue of Addison’s disease 2Combined 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 TrustNULLNot 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): noUnited Kingdom
10EUCTR2011-002687-25-DE
(EUCTR)
16/11/201106/10/2011Evaluation 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 WuerzburgNULLNot RecruitingFemale: yes
Male: yes
12Germany
11NCT01371526
(ClinicalTrials.gov)
September 20109/3/2011Revival of Stem Cells in Addison's StudyRevival of Autochthonous Adrenocortical Stem Cells in Autoimmune Addison's DiseaseAdrenal FailureDrug: depot tetracosactideNewcastle UniversityNULLCompleted16 Years66 YearsBoth13Phase 4United Kingdom
12EUCTR2009-010917-61-SE
(EUCTR)
25/08/201005/07/2010Glucocorticoid Replacement in Addison's diseaseGlucocorticoid 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 hospitalNULLNot RecruitingFemale: yes
Male: yes
40Sweden
13EUCTR2009-018074-56-GB
(EUCTR)
05/05/201018/03/2010Revival 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 TrustNULLNot RecruitingFemale: yes
Male: yes
12United Kingdom
14NCT01063569
(ClinicalTrials.gov)
February 201026/1/2010Glucocorticoid Treatment in Addison's DiseaseGlucocorticoid Treatment in Addison's DiseaseAddison's DiseaseDrug: Solu-Cortef (hydrocortisone);Drug: Cortef (hydrocortisone)Haukeland University HospitalNULLCompleted18 Years70 YearsBoth33Phase 2/Phase 3Norway;Sweden
15EUCTR2007-003062-18-GB
(EUCTR)
05/06/200815/02/2008Immunotherapeutic 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 TrustNULLNot RecruitingFemale: yes
Male: yes
10Phase 4United Kingdom
16NCT01271296
(ClinicalTrials.gov)
April 200822/12/2010Effects and Interactions of Liquorice and Grapefruit on Glucocorticoid Replacement Therapy in Addison's DiseaseUse of Liquorice and Grapefruit in Patients With Addison's DiseaseAddison DiseaseDietary Supplement: Liquorice;Dietary Supplement: Grapefruit JuiceHaukeland University HospitalNULLCompleted18 Years80 YearsBoth17N/ANorway
17EUCTR2007-005170-30-FR
(EUCTR)
08/12/200725/10/2007Pharmacocinétique de l’Hydrocortisone chez le patient ADdisonien : évaluation de la valeur prédictive de l’ACTH plasmatique pour la titration du traitement substitutif - PHADPharmacocinétique 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 CAENNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
18EUCTR2005-001768-30-SE
(EUCTR)
04/01/200607/12/2005Comparison of 2 and 4 doses hydrocortison substitution with regard to plasma concentration and quality of life. - CHEQComparison 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: HydrocortisoneEM-klinikenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Sweden
19NCT00688987
(ClinicalTrials.gov)
August 200030/5/2008The Hypothalamic-Pituitary-Adrenal (HPA) Axis as an Effector System in Weight RegulationCortisol, Central Obesity, and Insulin Resistance: Long Term Studies in Addison's PatientsObesity;Addison's DiseaseDrug: Hydrocortisone;Dietary Supplement: Isocaloric DietOregon Health and Science UniversityNULLCompleted18 YearsN/ABoth24N/AUnited States
20NCT00004313
(ClinicalTrials.gov)
August 199518/10/1999Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone Replacement for Primary Adrenal InsufficiencyAddison's DiseaseDrug: dehydroepiandrosteroneNational Center for Research Resources (NCRR)University of California, Los AngelesCompleted18 YearsN/ABoth40Phase 3NULL