Hydrocortisone    (DrugBank: Hydrocortisone)

9 diseases
告示番号疾患名(ページ内リンク)臨床試験数
6パーキンソン病1
46悪性関節リウマチ1
53シェーグレン症候群3
75クッシング病2
78下垂体前葉機能低下症3
81先天性副腎皮質酵素欠損症28
83アジソン病12
97潰瘍性大腸炎5
299嚢胞性線維症1

6. パーキンソン病 [臨床試験数:2,123,薬物数:2,046(DrugBank:324),標的遺伝子数:183,標的パスウェイ数:198
Searched query = "Parkinson disease"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
1 / 2,123 trial found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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PhaseCountries
1NCT02230930
(ClinicalTrials.gov)
June 201529/8/2014Treatment of Apomorphine-induced Skin Reactions: a Pilot StudyOpen-label Crossover Trial to Investigate the Efficacy of Treatments in Apomorphine-induced Skin ReactionsParkinson's Disease;Apomorphine-induced Skin ReactionsDrug: Apomorphine 0.25% (2.5mg/ml);Device: Massage with a spiky ball;Drug: Hydrocortisone cream 1%;Drug: Subcutaneous hydrocortisone 10mgUniversity Medical Center GroningenNULLRecruiting30 YearsN/AAll20Phase 2Netherlands

46. 悪性関節リウマチ [臨床試験数:4,183,薬物数:2,538(DrugBank:401),標的遺伝子数:183,標的パスウェイ数:219
Searched query = "Malignant rheumatoid arthritis", "Rheumatoid arthritis", "Rheumatoid arthritis with vasculitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
1 / 4,183 trial found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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PhaseCountries
1EUCTR2016-001618-18-FR
(EUCTR)
08/07/201609/06/2016Comparison of two STrategies of glucocorticoid withdrawal in rheumatoid Arthritis patientsSTARComparison of two STrategies of glucocorticoid withdrawal in rheumatoid Arthritis patients in low disease activity or Remission - STAR glucocorticoid withdrawal in rheumatoid arthritis
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Prednisone
Product Name: prednisone 5 mg
Trade Name: Prednisone
Product Name: prednisone 4 mg
Trade Name: Prednisone
Product Name: prednisone 3 mg
Trade Name: Prednisone
Product Name: prednisone 2 mg
Trade Name: Prednisone
Product Name: prednisone 1 mg
Trade Name: Hydrocortisone 10mg
CHU ToulouseNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
122Phase 4France

53. シェーグレン症候群 [臨床試験数:234,薬物数:270(DrugBank:85),標的遺伝子数:49,標的パスウェイ数:174
Searched query = "Sjogren syndrome", "Sjögren syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
3 / 234 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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agemax
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PhaseCountries
1NCT04597762
(ClinicalTrials.gov)
October 31, 202016/10/2020Effect of Ciclosporin Eyedrops on Sjögren SyndromeEffect of Ciclosporin Eyedrops on Ocular Symptoms and Optical Quality in Patients With Sjögren SyndromeDry Eye SyndromesDrug: Cyclosporin;Drug: HydrocortisoneHospital HietzingNULLRecruiting18 Years90 YearsAll12N/AAustria
2EUCTR2017-004929-33-AT
(EUCTR)
05/12/201827/11/2018Effect of Ciclosporin eyedrops on symptoms of the eye and visual quality in patients with dry eye syndrome and primary or secondary Sjögren syndromeEffect of Ciclosporin eyedrops on ocular symptoms and optical image quality in patients with primary or secondary Sjögren syndrome primary or secondary Sjögren Syndrome;Therapeutic area: Diseases [C] - Eye Diseases [C11]Trade Name: Ikervis
Product Name: Ikervis
INN or Proposed INN: CICLOSPORIN
Trade Name: Softacort
Product Name: Softacort
INN or Proposed INN: HYDROCORTISONE SODIUM PHOSPHATE
KH Hietzing, Department of OphthalmologyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 4Austria
3NCT02112019
(ClinicalTrials.gov)
June 20148/4/2014Endoscopic Treatment of Salivary Glands Affected by Sjögren's SyndromeEndoscopic Treatment of Salivary Glands Affected by Sjögren's Syndrome; A Randomised Controlled Pilot StudySjögren's SyndromeProcedure: Sialoendoscopy;Drug: saline;Drug: hydrocortisoneDerk Jan JagerNULLActive, not recruiting18 Years70 YearsAll50N/ANetherlands

75. クッシング病 [臨床試験数:191,薬物数:172(DrugBank:48),標的遺伝子数:61,標的パスウェイ数:121
Searched query = "Cushing disease", "Cushing"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
2 / 191 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
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Inclusion_
agemin
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agemax
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gender
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size
PhaseCountries
1JPRN-UMIN000041513
2014/07/0101/09/2020A new perioperative glucocorticosteroid replacement therapy for cushing syndromeA new perioperative glucocorticosteroid replacement therapy for cushing syndrome - A perioperative glucocorticosteroid replacement therapy PerioperativeHydrocortisone was given during adrenal resection by intravenous injectionon the surgical day.Tianjin Medical University General HospitalNULLRecruiting22years-old61years-oldMale and Female80Not selectedAsia(except Japan)
2NCT02889224
(ClinicalTrials.gov)
February 201230/8/2016In Vivo Study of Interactions Between the Endocannabinoid System and the Corticotropic Axis in ManIn Vivo Study of Interactions Between the Endocannabinoid System and the Corticotropic Axis in ManCushing's SyndromeOther: Obese;Procedure: Hypercortisolism;Other: Hydrocortisone;Other: ControlUniversity Hospital, BordeauxNULLCompleted18 YearsN/AAll40N/AFrance

78. 下垂体前葉機能低下症 [臨床試験数:462,薬物数:346(DrugBank:45),標的遺伝子数:41,標的パスウェイ数:80
Searched query = "Hypopituitarism", "Anterior pituitary hypothyroidism", "Syndrome of abnormal secretion of gonadotropin", "Hyposecretion of gonadotropins", "Adrenocorticotropic hormone deficiency", "ACTH deficiency", "Thyroid-stimulating hormone deficiency", "TSH deficiency", "Growth hormone deficiency", "GH deficiency", "GHD", "CGHD", "AGHD", "Prolactin deficiency", "PRL deficiency"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
3 / 462 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
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agemin
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agemax
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size
PhaseCountries
1NCT02360046
(ClinicalTrials.gov)
January 201516/1/2015The Influence of Different Hydrocortisone Replacement Doses on the Partitioning and Flexibility of Ectopic Lipids in Patients With Corticotropic HypopituitarismThe Influence of Different Hydrocortisone Replacement Doses on the Partitioning and Flexibility of Ectopic Lipids (Intrahepatocellular IHCL and Intramyocellular IMCL) in Patients With Corticotropic Hypopituitarism, a Randomised Placebo-controlled Double-blind TrialHypopituitarism;Hydrocortisone;Lipids;Fatty Acids, Nonesterified;Insulin SensitivityDrug: Hydrocortisone;Drug: PlaceboUniversity Hospital Inselspital, BerneNULLTerminated18 YearsN/AAll30N/ASwitzerland
2EUCTR2014-002039-32-DK
(EUCTR)
02/09/201407/07/2014Fatigue in patients with adrenal insufficiency - a comparison of the effect of a new modified-release hydrocortisone, and conventional hydrocortisone.PlenadrEMA study - Effect of modified-release compared to conventional hydrocortisone on fatigue, measured by Ecological Momentary Assessments; a pilot study to assess feasibility, responsiveness of outcomes and to inform power calculations for future large-scale RCTs - PlenadrEMA study Secondary adrenal insufficiency due to hypopituitarism
MedDRA version: 20.0;Level: LLT;Classification code 10052382;Term: Secondary adrenal insufficiency;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Plenadren 5 mg modified-release tablets
INN or Proposed INN: Hydrocortisone
Other descriptive name: HYDROCORTISONE
Trade Name: Hydrocortisone TAKEDA, tabletter
INN or Proposed INN: Hydrocortisone
Other descriptive name: HYDROCORTISONE
Product Name: Hydrokortison Glostrup 5 mg
INN or Proposed INN: Hydrocortisone
Other descriptive name: HYDROCORTISONE
Trade Name: Plenadren 20 mg modified-release tablets
INN or Proposed INN: Hydrocortisone
Other descriptive name: HYDROCORTISONE
Rigshospitalet, Copenhagen University HospitalNULLNot RecruitingFemale: yes
Male: yes
30Phase 4Denmark
3EUCTR2007-005018-37-IE
(EUCTR)
18/01/200807/09/2007Optimal glucocorticoid replacement therapy in adrenocorticotropin (ACTH) deficient hypopituitary patients - Optimal glucocorticoid replacementOptimal glucocorticoid replacement therapy in adrenocorticotropin (ACTH) deficient hypopituitary patients - Optimal glucocorticoid replacement 10 male patients with hypopituitarism resulting in ACTH (adrenocorticotropin) deficiency (ICD E23.0) will be studied on varying doses of hydrocortisone replacement therapy. THis is not a new medication for these patients.10 healthy male volunteers will be studied as control subjects. They will NOT receive hydrocortisone.
MedDRA version: 9.1;Level: LLT;Classification code 10021067;Term: Hypopituitarism
MedDRA version: 9.1;Classification code 10033662;Term: Panhypopituitarism
MedDRA version: 9.1;Classification code 10057217;Term: Isolated ACTH deficiency
Trade Name: Hydrocortone
INN or Proposed INN: Hydrocortisone
INN or Proposed INN: Hydrocortisone
Amar AghaNULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
20Ireland

81. 先天性副腎皮質酵素欠損症 [臨床試験数:65,薬物数:77(DrugBank:20),標的遺伝子数:11,標的パスウェイ数:65
Searched query = "Congenital adrenal hyperplasia", "Congenital adrenal enzyme deficiency", "Congenial adrenal cortex enzyme deficiency", "Congenital Lipoid Adrenal Hyperplasia", "3β-Hydroxysteroid Dehydrogenase Deficiency", "21-Hydroxylase deficiency", "11β-Hydroxylase deficiency", "17α-Hydroxylase deficiency", "P450 oxidoreductase deficiency", "Aldosterone synthase deficiency"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
28 / 65 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
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agemax
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gender
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size
PhaseCountries
1NCT03548246
(ClinicalTrials.gov)
January 202224/4/2015Androgen Reduction in Congenital Adrenal HyperplasiaA Phase 1-2 Multi-Center Study to Assess the Efficacy and Safety of Abiraterone Acetate as Adjunctive Therapy in Pre-Pubescent Children With Classic 21-Hydroxylase DeficiencyCongenital Adrenal HyperplasiaDrug: Abiraterone acetate;Drug: Placebo;Drug: Hydrocortisone;Drug: FludrocortisoneUniversity of Texas Southwestern Medical CenterNational Institutes of Health Clinical Center (CC);University of Michigan;Children's Hospital Los Angeles;Feinstein Institute for Medical ResearchNot yet recruiting2 Years9 YearsAll54Phase 2United States
2NCT04536662
(ClinicalTrials.gov)
October 1, 202023/8/2020Comparisons of Different Forms of Glucocorticoid on the Recovery of Reproductive Function in Patients With 21a-hydroxylase DeficiencyComparisons of Different Forms of Glucocorticoid on the Recovery of Reproductive Function in Patients With 21a-hydroxylase DeficiencyCongenital Adrenal HyperplasiaDrug: Hydrocortisone;Drug: Prednisone;Drug: DexamethasoneShanghai Jiao Tong University School of MedicineNULLNot yet recruiting14 Years45 YearsAll120Phase 4China
3EUCTR2018-004802-24-NL
(EUCTR)
20/05/201913/05/2019Avoiding over and undertreatment by optimizing of the timing ofglucocorticoïd treatment in children with cnogenital adrenal hyperplasiaOptimizing timing of glucocorticoid treatment in children with congenitaladrenal hyperplasia - OPTIMED study Congenital adrenal hyperplasia (CAH) is a disorder of adrenal steroidsynthesis leading to cortisol deficiency and an increase in androgenproduction.Treatment in children consists of hydrocortisone substitutionthereby also restoring the negative feedback on the pituitary gland andconsequently normalize androgen production. There is still no evidenceabout the best timing of hydrocortisone use: The highest dosage ofhydrocortisone in the morning or the highest dosage at night;Therapeutic area: Diseases [C] - Hormonal diseases [C19]Product Name: Hydrocortisone
INN or Proposed INN: Hydrocortisone
Other descriptive name: HYDROCORTISONE
Radboud University Nijmegen Medical CentreNULLNot RecruitingFemale: yes
Male: yes
50Phase 2Netherlands
4NCT03718234
(ClinicalTrials.gov)
January 1, 201911/10/2018Subcutaneous Hydrocortisone Children With Congenital Adrenal HyperplasiaInterval Bolus Delivery of Subcutaneous Hydrocortisone Via Infusion Pump in Children With Congenital Adrenal HyperplasiaCongenital Adrenal Hyperplasia;Hyperplasia;Adrenal Hyperplasia;Congenital Disorders;Adrenocortical Hyperfunction;Disorders of Sex Development;Urogenital Abnormalities;Genetic Diseases, Inborn;Steroid Metabolic Diseases, Inborn;Adrenal Gland Disease;HydrocortisoneDrug: Subcutaneous hydrocortisone;Drug: Standard glucocorticoid therapyUniversity of MinnesotaNULLRecruiting4 Years18 YearsAll8Phase 1United States
5EUCTR2015-005448-32-DK
(EUCTR)
01/09/201728/06/2017The proposed study aims to build on the results of clinical studies DIUR-003 and DIUR-005 and evaluate the long-term safety of Chronocort® and also its long term efficacy.A Phase III extension study of efficacy, safety and tolerability of Chronocort® in the treatment of congenital adrenal hyperplasia (CAH) Congenital adrenal hyperplasia (CAH); is generally due to 21-hydroxylase deficiency, is a disease of the adrenal cortex characterised by cortisol deficiency with or without aldosterone deficiency, and androgen excess. Subjects with CAH are at risk of developing a number of clinical manifestations, such as obesity in children, insulin resistance, and polycystic ovaries, which may contribute to infertility in women with CAH. Oligomenorrhoea or amenorrhoea may be present in adolescence.
MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Chronocort®
Product Code: DIURF-006
INN or Proposed INN: HYDROCORTISONE
Other descriptive name: Cortisol
Diurnal LtdNULLNot RecruitingFemale: yes
Male: yes
136Phase 3France;United States;Denmark;Netherlands;Germany;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2015-000711-40-DK
(EUCTR)
08/09/201611/07/2016Chronocort®, a slow release medicinal preparation of hydrocortisone, will be compared with currently used glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia seeking to assess its safety, tolerability and effectiveness.A Phase III study of efficacy, safety and tolerability of Chronocort® compared with standard glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia. Congenital adrenal hyperplasia (CAH); is generally due to 21-hydroxylase deficiency, is a disease of the adrenal cortex characterised by cortisol deficiency with or without aldosterone deficiency, and androgen excess. Subjects with CAH are at risk of developing a number of clinical manifestations, such as obesity in children, insulin resistance, and polycystic ovaries, which may contribute to infertility in women with CAH. Oligomenorrhoea or amenorrhoea may be present in adolescence.
MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000012082;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Chronocort®
Product Code: DIURF-006
INN or Proposed INN: HYDROCORTISONE
Other descriptive name: Cortisol
Trade Name: Hydrocortisone 10mg Tablets
INN or Proposed INN: Hydrocortisone
Other descriptive name: HYDROCORTISONE
Trade Name: Dexamethasone 0,1 mg Tablets
INN or Proposed INN: DEXAMETHASONE
Trade Name: Prednisolone 2,5 mg Tablets
INN or Proposed INN: Prednisolone
Other descriptive name: PREDNISOLONE
Product Name: Hydrocortisone tablet 2.5 mg
Diurnal LtdNULLNot RecruitingFemale: yes
Male: yes
120Phase 3France;United States;Denmark;Netherlands;Germany;United Kingdom;Sweden
7NCT03062280
(ClinicalTrials.gov)
August 18, 201622/8/2016A Study of the Efficacy, Safety and Tolerability of Chronocort in Treating CAHA Phase III Extension Study of Efficacy, Safety and Tolerability of Chronocort® in the Treatment of Congenital Adrenal HyperplasiaCongenital Adrenal HyperplasiaDrug: HydrocortisoneDiurnal LimitedNULLActive, not recruiting18 YearsN/AAll92Phase 3United States
8NCT03760835
(ClinicalTrials.gov)
August 11, 20169/11/2018Congenital Adrenal Hyperplasia Once Daily Hydrocortisone TreatmentCongenital Adrenal Hyperplasia: Innovative Once Daily Dual Release Hydrocortisone TreatmentCongenital Adrenal HyperplasiaDrug: Conventional Glucocorticoids (immediate release hydrocortisone, cortisone acetate, prednisone, prednisolone, dexamethasone);Drug: Dual release hydrocortisone (plenadren)Federico II UniversityNULLRecruiting18 YearsN/AAll150Phase 4Italy
9EUCTR2015-005448-32-GB
(EUCTR)
20/07/201605/07/2016The proposed study aims to build on the results of clinical studies DIUR-003 and DIUR-005 and evaluate the long-term safety of Chronocort® and also its long term efficacy.A Phase III extension study of efficacy, safety and tolerability of Chronocort® in the treatment of congenital adrenal hyperplasia (CAH) Congenital adrenal hyperplasia (CAH); is generally due to 21-hydroxylase deficiency, is a disease of the adrenal cortex characterised by cortisol deficiency with or without aldosterone deficiency, and androgen excess. Subjects with CAH are at risk of developing a number of clinical manifestations, such as obesity in children, insulin resistance, and polycystic ovaries, which may contribute to infertility in women with CAH. Oligomenorrhoea or amenorrhoea may be present in adolescence.
MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Chronocort®
Product Code: DIURF-006
INN or Proposed INN: HYDROCORTISONE
Other descriptive name: Cortisol
Diurnal LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
136Phase 3France;United States;Denmark;Netherlands;Germany;United Kingdom;Sweden
10EUCTR2015-000711-40-DE
(EUCTR)
23/05/201606/10/2015Chronocort®, a slow release medicinal preparation of hydrocortisone, will be compared with currently used glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia seeking to assess its safety, tolerability and effectiveness.A Phase III study of efficacy, safety and tolerability of Chronocort® compared with standard glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia. Congenital adrenal hyperplasia (CAH); is generally due to 21-hydroxylase deficiency, is a disease of the adrenal cortex characterised by cortisol deficiency with or without aldosterone deficiency, and androgen excess. Subjects with CAH are at risk of developing a number of clinical manifestations, such as obesity in children, insulin resistance, and polycystic ovaries, which may contribute to infertility in women with CAH. Oligomenorrhoea or amenorrhoea may be present in adolescence.
MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Diurnal LtdNULLNot Recruiting Female: yes
Male: yes
120 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Denmark;Netherlands;Germany;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2015-000711-40-NL
(EUCTR)
28/04/201617/11/2015Chronocort®, a slow release medicinal preparation of hydrocortisone, will be compared with currently used glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia seeking to assess its safety, tolerability and effectiveness.A Phase III study of efficacy, safety and tolerability of Chronocort® compared with standard glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia. Congenital adrenal hyperplasia (CAH); is generally due to 21-hydroxylase deficiency, is a disease of the adrenal cortex characterised by cortisol deficiency with or without aldosterone deficiency, and androgen excess. Subjects with CAH are at risk of developing a number of clinical manifestations, such as obesity in children, insulin resistance, and polycystic ovaries, which may contribute to infertility in women with CAH. Oligomenorrhoea or amenorrhoea may be present in adolescence.
MedDRA version: 18.1;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Chronocort®
Product Code: DIURF-006
INN or Proposed INN: HYDROCORTISONE
Other descriptive name: Cortisol
Trade Name: Hydrocortisone 20mg Tablets
INN or Proposed INN: Hydrocortisone
Other descriptive name: HYDROCORTISONE
Trade Name: Dexamethasone 1,5 mg Tablets
INN or Proposed INN: DEXAMETHASONE
Trade Name: Prednisolone 5 mg Tablets
INN or Proposed INN: Prednisolone
Other descriptive name: PREDNISOLONE
Diurnal LtdNULLNot RecruitingFemale: yes
Male: yes
110Phase 3United States;Denmark;Germany;Netherlands;United Kingdom;Sweden
12EUCTR2015-000711-40-SE
(EUCTR)
11/01/201613/10/2015Chronocort®, a slow release medicinal preparation of hydrocortisone, will be compared with currently used glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia seeking to assess its safety, tolerability and effectiveness.A Phase III study of efficacy, safety and tolerability of Chronocort® compared with standard glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia. Congenital adrenal hyperplasia (CAH); is generally due to 21-hydroxylase deficiency, is a disease of the adrenal cortex characterised by cortisol deficiency with or without aldosterone deficiency, and androgen excess. Subjects with CAH are at risk of developing a number of clinical manifestations, such as obesity in children, insulin resistance, and polycystic ovaries, which may contribute to infertility in women with CAH. Oligomenorrhoea or amenorrhoea may be present in adolescence.
MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000012082;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Chronocort®
Product Code: DIURF-006
INN or Proposed INN: HYDROCORTISONE
Other descriptive name: Cortisol
Trade Name: Hydrocortisone 20mg Tablets
INN or Proposed INN: Hydrocortisone
Other descriptive name: HYDROCORTISONE
Trade Name: Dexamethasone 2mg Tablets
INN or Proposed INN: DEXAMETHASONE
Trade Name: Prednisolone 1mg Tablets
INN or Proposed INN: Prednisolone
Other descriptive name: PREDNISOLONE
Diurnal LtdNULLNot RecruitingFemale: yes
Male: yes
120Phase 3France;United States;Denmark;Netherlands;Germany;United Kingdom;Sweden
13EUCTR2015-000711-40-GB
(EUCTR)
19/11/201528/07/2015Chronocort®, a slow release medicinal preparation of hydrocortisone, will be compared with currently used glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia seeking to assess its safety, tolerability and effectiveness.A Phase III study of efficacy, safety and tolerability of Chronocort® compared with standard glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia. Congenital adrenal hyperplasia (CAH); is generally due to 21-hydroxylase deficiency, is a disease of the adrenal cortex characterised by cortisol deficiency with or without aldosterone deficiency, and androgen excess. Subjects with CAH are at risk of developing a number of clinical manifestations, such as obesity in children, insulin resistance, and polycystic ovaries, which may contribute to infertility in women with CAH. Oligomenorrhoea or amenorrhoea may be present in adolescence.
MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Diurnal LtdNULLNot Recruiting Female: yes
Male: yes
120 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Denmark;Netherlands;Germany;United Kingdom;Sweden
14EUCTR2015-000458-40-DE
(EUCTR)
20/10/201521/08/2015Open-label, long-term follow-up of safety and biochemical disease control of Infacort® in neonates, infants and children with congenital adrenal hyperplasia and adrenal insufficiency previously enrolled in the Infacort 003 studyOpen-label, long-term follow-up of safety and biochemical disease control of Infacort® in neonates, infants and children with congenital adrenal hyperplasia and adrenal insufficiency previously enrolled in the Infacort 003 study - Infacort004 Adrenal Insufficiency (AI) in children is most commonly due to Congenital Adrenal Hyperplasia (CAH) and results in cortisol deficiency with or without aldosterone deficiency and androgen excess. Current standard treatment in neonates is unsatisfactory, as unlicensed and crushed adult dosage formulations (Hydrocortisone tablets,10 mg) are used. Infacort® is a new paediatric and neonatal formulation of hydrocortisone that is provided in appropriate unit dosage (0.5mg, 1.0mg, 2.0mg and 5mg);Therapeutic area: Diseases [C] - Hormonal diseases [C19]Diurnal LimitedNULLNot Recruiting Female: yes
Male: yes
24 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noGermany
15EUCTR2014-002265-30-DE
(EUCTR)
19/02/201523/12/2014A Phase 3 open-label study of Infacort® in neonates, infants and children less than 6 years of age with adrenal insufficiency.A Phase 3 open-label study of Infacort® in neonates, infants and children less than 6 years of age with adrenal insufficiency. Adrenal Insufficiency (AI) in children is most commonly due to Congenital Adrenal Hyperplasia (CAH) and results in cortisol deficiency with or without aldosterone deficiency and androgen excess. Current standard treatment in neonates is unsatisfactory, as unlicensed and crushed adult dosage formulations (Hydrocortisone tablets, 10 mg) are used. Infacort® is a new paediatric and neonatal formulation of hydrocortisone that is provided in appropriate unit dosage (0.5mg, 1.0mg, 2.0mg and 5mg).;Therapeutic area: Diseases [C] - Hormonal diseases [C19]Product Name: infacort
INN or Proposed INN: infacort
Other descriptive name: HYDROCORTISONE
Product Name: infacort
INN or Proposed INN: infacort
Other descriptive name: HYDROCORTISONE
Product Name: infacort
INN or Proposed INN: infacort
Other descriptive name: HYDROCORTISONE
Product Name: infacort
INN or Proposed INN: infacort
Other descriptive name: HYDROCORTISONE
Diurnal LimitedNULLNot RecruitingFemale: yes
Male: yes
Phase 3Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
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Inclusion_
agemin
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agemax
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size
PhaseCountries
16EUCTR2011-005822-23-SE
(EUCTR)
18/11/201420/09/2013A trial comparing continuous subcutaneous hydrocortisone infusion (CSHI) therapy with conventional oral glucocorticoid therapy in patients with Congenital Andrenal Hyperplasia (CAH)CONTINUOUS SUBCUTANEOUS HYDROCORTISONE INFUSION IN CONGENITAL ADRENAL HYPERPLASIA Congenital Adrenal Hyperplasia
MedDRA version: 14.1;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Solu-Cortef
INN or Proposed INN: HYDROCORTISONE SODIUM SUCCINATE
Other descriptive name: HYDROCORTISONE SODIUM SUCCINATE
INN or Proposed INN: Prednisolone
INN or Proposed INN: Hydrocortisone
Haukeland University HospitalNULLNot RecruitingFemale: yes
Male: yes
20Phase 2Norway;Sweden
17EUCTR2012-001104-37-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
18NCT02096510
(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
19NCT01859312
(ClinicalTrials.gov)
May 6, 201317/5/2013Comparison of Cortisol Pump With Standard Treatment for Congenital Adrenal HyperplasiaA Pilot Study Assessing the Use of Continuous Subcutaneous Hydrocortisone Infusion in the Treatment of Congenital Adrenal HyperplasiaAdrenal Insufficiency;Excess Androgen;Congenital Adrenal Hyperplasia (CAH)Drug: Hydrocortisone (Solucortef);Device: Insulin pump (Medtronic)National Institutes of Health Clinical Center (CC)Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Completed18 Years99 YearsAll8Phase 2United States
20NCT01771328
(ClinicalTrials.gov)
February 201310/1/2013Continuous Subcutaneous Hydrocortisone Infusion in Congenital Adrenal HyperplasiaContinuous Subcutaneous Hydrocortisone Infusion in Congenital Adrenal HyperplasiaAdrenal Hyperplasia, CongenitalDrug: Hydrocortisone;Drug: Cortisone acetateHaukeland University HospitalNULLRecruiting18 Years60 YearsBoth20Phase 2Norway
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
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gender
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size
PhaseCountries
21NCT01735617
(ClinicalTrials.gov)
December 201220/11/2012Pilot Study to Characterize and Examine the Pharmacokinetics and Efficacy of Chronocort® in Adults With CAHA Phase 2 Pilot Study to Characterize and Examine the Pharmacokinetics and Disease Bio-marker Response of Chronocort® in Adults With Congenital Adrenal HyperplasiaEndocrine Disease;Adrenal Insufficiency;Congenital Adrenal HyperplasiaDrug: Hydrocortisone Modified Release CapsulesDiurnal LimitedNational Institutes of Health (NIH)Completed18 YearsN/AAll16Phase 2United States
22EUCTR2011-005822-23-NO
(EUCTR)
16/10/201225/02/2013A trial comparing continuous subcutaneous hydrocortisone therapy with conventional oral glucocorticoid therapy in congenital adrenal hyperplasiaCONTINUOUS SUBCUTANEOUS HYDROCORTISONE INFUSION IN CONGENITAL ADRENAL HYPERPLASIA Congenital adrenal hyperplasia (CAH)
MedDRA version: 14.1;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Solu-Cortef
Trade Name: Cortison
Trade Name: Prednisolone
Haukeland University HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Norway
23NCT03019614
(ClinicalTrials.gov)
March 201011/1/2017An Open Label Study in Healthy Volunteers to Compare Chronocort® to HydrocortisoneAn Open Label, Randomised, Single Dose, 3-period Crossover Study in Healthy Volunteers to: a) Compare the Pharmacokinetics of Chronocort® Formulations Versus Immediate Release Hydrocortisone, and (b) Determine the Dose Proportionality of Chronocort® FormulationsCongenital Adrenal Hyperplasia;Adrenal InsufficiencyDrug: Hydrocortisone;Drug: ChronocortDiurnal LimitedSimbec ResearchCompleted18 Years60 YearsMale30Phase 1NULL
24NCT00621985
(ClinicalTrials.gov)
April 200811/2/2008Dexamethasone Treatment of Congenital Adrenal HyperplasiaDexamethasone Treatment of Congenital Adrenal HyperplasiaAdrenal Hyperplasia, CongenitalDrug: dexamethasone;Drug: HydrocortisoneBoston Children’s HospitalNULLCompleted2 Years9 YearsAll5Phase 2United States
25NCT00519818
(ClinicalTrials.gov)
August 200722/8/2007Comparison of Two Forms of Hydrocortisone in Patients With Congenital Adrenal HyperplasiaA Phase 2, Open Label, Crossover Pharmacokinetic and Pharmacodynamic Study to Compare Chronocort Versus Cortef in Patients With CAHCongenital Adrenal Hyperplasia;21-Hydroxylase Deficiency;Adrenogenital SyndromeDrug: Chronocort;Drug: CortefDiurnal LimitedNational Institutes of Health Clinical Center (CC)Completed16 Years60 YearsAll20Phase 1/Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT00542841
(ClinicalTrials.gov)
August 200710/10/2007Examining Genetic Differences Among People With 21-Hydroxylase DeficiencyModifier Genes in 21-Hydroxylase Deficiency21-hydroxylase DeficiencyProcedure: Hydrocortisone withdrawalMaria I. NewOffice of Rare Diseases (ORD);National Center for Research Resources (NCRR)Completed18 Years50 YearsBoth99N/AUnited States;Brazil;France
27NCT00529841
(ClinicalTrials.gov)
January 200712/9/2007Research Study for Children With Salt Wasting Congenital Adrenal HyperplasiaA Novel Therapeutic Modality for Congenital Adrenal HyperplasiaAdrenal Hyperplasia, CongenitalDrug: Hydrocortisone sodium acetateBaylor College of MedicineNULLCompleted3 Years18 YearsBoth7N/AUnited States
28NCT00001521
(ClinicalTrials.gov)
June 8, 19953/11/1999Three Drug Combination Therapy Versus Conventional Treatment of Children With Congenital Adrenal HyperplasiaAn Open, Randomized, Long-Term Clinical Trial of Flutamide, Testolactone, and Reduced Hydrocortisone Dose vs. Conventional Treatment of Children With Congenital Adrenal HyperplasiaCongenital Adrenal Hyperplasia (CAH)Drug: Flutamide;Drug: Letrozole;Drug: Hydrocortisone;Drug: FludrocortisoneEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NULLActive, not recruiting2 Years18 YearsAll62Phase 2United States

83. アジソン病 [臨床試験数:20,薬物数:42(DrugBank:13),標的遺伝子数:6,標的パスウェイ数:17
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. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
12 / 20 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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PhaseCountries
1EUCTR2015-001090-40-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
2EUCTR2012-001104-37-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
3NCT02096510
(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
4NCT02152553
(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
5EUCTR2013-004189-33-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
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PhaseCountries
6NCT01847690
(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
7EUCTR2011-002687-25-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
8EUCTR2009-010917-61-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
9NCT01063569
(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
10EUCTR2007-005170-30-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
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Target_
size
PhaseCountries
11EUCTR2005-001768-30-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
12NCT00688987
(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

97. 潰瘍性大腸炎 [臨床試験数:2,269,薬物数:1,331(DrugBank:241),標的遺伝子数:114,標的パスウェイ数:181
Searched query = "Ulcerative colitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
5 / 2,269 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04469686
(ClinicalTrials.gov)
July 30, 20202/7/2020Phase 3 Study to Evaluate the Safety and Efficacy of Hydrocortisone Acetate Suppositories3-Arm Randomized Placebo Controlled Double Blind Phase 3 Study to Evaluate Safety and Efficacy of Once-Daily and Twice-Daily Hydrocortisone Acetate 90 mg Suppository Administered With a Sephure Applicator in Subjects With Ulcerative ColitisUlcerative ProctitisCombination Product: Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator;Combination Product: Once daily 90 mg hydrocortisone acetate or placebo suppository administered with Sephure applicator;Combination Product: Twice daily placebo suppository administered with Sephure applicatorCristcot LLCCristcot HCA LLCRecruiting18 YearsN/AAll618Phase 3United States
2EUCTR2019-003596-19-DE
(EUCTR)
29/07/202029/07/2020A Three-Arm, Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Safety and Efficacy of Once-Daily and Twice-Daily Dosing of a Novel Hydrocortisone Acetate 90 mg Suppository Formulation Administered with the Sephure® Suppository Applicator in Subjects with Ulcerative Colitis of the Rectum.A Three-Arm, Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Safety and Efficacy of Once-Daily and Twice-Daily Dosing of a Novel Hydrocortisone Acetate 90 mg Suppository Formulation Administered with the Sephure® Suppository Applicator in Subjects with Ulcerative Colitis of the Rectum. - cessa Ulcerative Colitis of the Rectum
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;Level: HLT;Classification code 10027682;Term: Immune and associated conditions NEC;System Organ Class: 10021428 - Immune system disorders
MedDRA version: 20.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;Level: HLGT;Classification code 10027665;Term: Immune disorders NEC;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: 90 mg hydrocortisone acetate suppository with Sephure suppository applicator
INN or Proposed INN: HYDROCORTISONE ACETATE
Cristcot HCA LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
618Phase 3United States;Philippines;Hong Kong;Spain;Poland;Ukraine;Romania;Russian Federation;Germany;Italy;India
3NCT03110198
(ClinicalTrials.gov)
May 201719/2/2017Mesalazine With Hydrocortisone Sodium Succinate Enema for 4-Week Treatment in Patients With Ulcerative ColitisA Randomized, Double-blind Study Investigating the Efficacy and Safety of Mesalazine With Hydrocortisone Sodium Succinate (100mg QD) Enema for 4-Week Treatment in Patients With Ulcerative Colitis (UC)Ulcerative Colitis, UnspecifiedDrug: Mesalazine;Drug: hydrocortisone sodium succinate;Drug: Mesalazine with hydrocortisone sodium succinateXijing Hospital of Digestive DiseasesShanghai Tongji Hospital, Tongji University School of Medicine;First Affiliated Hospital of Zhongshan Medical UniversityRecruiting18 Years70 YearsAll528Phase 4China
4NCT02425852
(ClinicalTrials.gov)
December 201621/4/2015A Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus IFX to Steroids Plus Azathioprine for Acute Severe ColitisA Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus Infliximab to Corticosteroids Plus Azathioprine for Acute Severe ColitisUlcerative ColitisDrug: Azathioprine;Drug: Infliximab;Drug: Prednisolone;Drug: HydrocortisoneGroupe d'Etude Therapeutique des Affections Inflammatoires DigestivesNULLRecruiting18 YearsN/AAll146Phase 4France
5NCT00805285
(ClinicalTrials.gov)
October 20088/12/2008The Use of Oral Budesonide and Rectal Hydrocortisone for the Treatment of Active Ulcerative ColitisOral Budesonide and Rectal Hydrocortisone for the Treatment of Extensive Ulcerative Colitis: A Pilot StudyInflammatory Bowel Disease;Ulcerative ColitisDrug: Combination Oral Budesonide and Rectal HydrocortisoneUniversity of Maryland, BaltimoreNULLTerminated18 YearsN/AAll1Phase 2United States

299. 嚢胞性線維症 [臨床試験数:1,592,薬物数:1,539(DrugBank:255),標的遺伝子数:81,標的パスウェイ数:162
Searched query = "Cystic fibrosis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
1 / 1,592 trial found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
Inclusion_
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Inclusion_
gender
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size
PhaseCountries
1EUCTR2011-005790-23-GB
(EUCTR)
17/07/201206/06/2012Comparison of recovery of adrenal gland function following short and long term steroid treatmentComparison of adrenal recovery following short and long-term glucocorticoid therapy. - Adrenal recovery following short and long-term glucocorticoid therapy Adrenal recovery following long and short term steroid treatment.
MedDRA version: 14.1;Level: LLT;Classification code 10066550;Term: Chronic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.1;Classification code 10000842;Term: Acute lymphatic leukaemia;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 14.1;Classification code 10008953;Term: Chronic liver disease;System Organ Class: 10019805 - Hepatobiliary disorders
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Physiological processes [G07]
Product Name: Prednisolone
INN or Proposed INN: Prednisolone
Product Name: Hydrocortisone
INN or Proposed INN: Hydrocortisone
Birmingham Children's Hospital NHS Foundation TrustNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60United Kingdom