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 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.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"
No.TrialIDDate_
enrollement
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Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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PhaseCountries
1NCT03210545September 1, 201912 November 2018A 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 StudyAddison DiseaseDrug: DexamethasoneGöteborg UniversityNot recruiting20 Years60 YearsAll30Phase 4Sweden
2NCT03793114September 26, 201827 May 2019Screening 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 fluidUniversity of BergenKarolinska Institutet;Charite University, Berlin, GermanyRecruiting18 Years70 YearsAll200N/AGermany;Norway;Sweden
3EUCTR2015-001090-40-GB22/06/201528 September 2015Effects of hydrocortisone injection into deltoid and thigh musclesAn 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 & ThighAddison's Disease;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]Trade Name: Efcortesol
Product Name: Hydrocortisone Efcortesol & Solu-Cortef
Pharmaceutical Form: Injection
The London ClinicAuthorisedFemale: yes
Male: yes
8United Kingdom
4EUCTR2012-001104-37-GB06/10/201423 March 2015pulses studyPulsed glucocorticoid replacement therapy for patients with adrenocortical insufficiency secondary to Addison’s disease and congenital adrenal hyperplasia - the pulses studyAddison'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 TrustAuthorisedFemale: yes
Male: yes
United Kingdom
5NCT02096510August 20149 January 2017Ultradian 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 HospitalRecruiting18 Years65 YearsBoth10Phase 1/Phase 2Norway
No.TrialIDDate_
enrollement
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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6NCT02152553May 201413 May 2019Biomarker(s) for GlucocorticoidsProtein/Metabolite Biomarker(s) for Glucocorticoid Action; an Experimental Trial in Patients With Adrenal InsufficiencyAddison DiseaseDrug: Hydrocortisone;Drug: PlaceboVastra Gotaland RegionNot recruiting20 Years60 YearsAll11N/ASweden
7EUCTR2013-004189-33-NO28/11/201328 April 2014A trial comparing continuous subcutaneous hydrocortisone therapy with pulsatile subcutaneous hydrocortisone therapy in patients with Addison`s diseaseULTRADIAN SUBCUTANEOUS HYDROCORTISONE (USHI) INFUSION IN ADDISON’S DISEASEAddison`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 HospitalAuthorisedFemale: yes
Male: yes
10Norway
8NCT01847690June 201319 February 2015Effect of Cortisol on Physical Exertion in Patients With Primary Adrenal FailureEffect of Cortisol on Physical Exertion in Patients With Primary AdrenalAddison DiseaseDrug: HydrocortisoneHaukeland University HospitalNot recruiting18 Years70 YearsFemale20Phase 2Norway
9EUCTR2012-001682-33-GB06/09/201230 April 2019Rescue 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 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 TrustNot Recruiting Female: yes
Male: yes
30Phase 2United Kingdom
10EUCTR2009-018074-56-GB05/05/20103 December 2012Revival 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 TrustNot RecruitingFemale: yes
Male: yes
12United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Inclusion_
agemin
Inclusion_
agemax
Inclusion_
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size
PhaseCountries
11NCT01063569February 201019 February 2015Glucocorticoid Treatment in Addison's DiseaseGlucocorticoid Treatment in Addison's DiseaseAddison's DiseaseDrug: Solu-Cortef (hydrocortisone);Drug: Cortef (hydrocortisone)Haukeland University HospitalNot recruiting18 Years70 YearsBoth33Phase 2/Phase 3Norway;Sweden
12EUCTR2007-003062-18-GB05/06/200819 March 2012Immunotherapeutic 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 TrustAuthorisedFemale: yes
Male: yes
10United Kingdom
13NCT01271296April 200819 February 2015Effects 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 HospitalNot recruiting18 Years80 YearsBoth17N/ANorway
14EUCTR2007-005170-30-FR08/12/200719 March 2012Pharmacocinétique 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 - PHADADDISON'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 CAENAuthorisedFemale: yes
Male: yes
France
15EUCTR2005-001768-30-SE04/01/200619 March 2012Comparison 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. - CHEQWe 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-klinikenAuthorisedFemale: yes
Male: yes
12Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT00688987August 200019 February 2015The 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 UniversityNot recruiting18 YearsN/ABoth24N/AUnited States
17NCT00004313August 199519 February 2015Phase 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 AngelesNot recruiting18 YearsN/ABoth40Phase 3

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