Calcium ( DrugBank: Calcium )


30 diseases
告示番号疾患名(ページ内リンク)臨床試験数
3脊髄性筋萎縮症1
6パーキンソン病1
13多発性硬化症/視神経脊髄炎10
15封入体筋炎1
19ライソゾーム病1
46悪性関節リウマチ8
49全身性エリテマトーデス6
51全身性強皮症1
53シェーグレン症候群1
56ベーチェット病1
68黄色靱帯骨化症1
75クッシング病1
79家族性高コレステロール血症(ホモ接合体)8
84サルコイドーシス2
93原発性胆汁性胆管炎2
94原発性硬化性胆管炎1
95自己免疫性肝炎1
96クローン病8
97潰瘍性大腸炎9
186ロスムンド・トムソン症候群1
214心室中隔欠損を伴う肺動脈閉鎖症1
215ファロー四徴症1
222一次性ネフローゼ症候群1
224紫斑病性腎炎1
235副甲状腺機能低下症13
256筋型糖原病1
265脂肪萎縮症1
274骨形成不全症2
298遺伝性膵炎2
299嚢胞性線維症2

3. 脊髄性筋萎縮症


臨床試験数 : 217 薬物数 : 149 - (DrugBank : 33) / 標的遺伝子数 : 54 - 標的パスウェイ数 : 80
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05272969
(ClinicalTrials.gov)
March 31, 202228/1/2022Pompe & Pain - Study to Assess Nociceptive Pain in Adult Patients With Pompe DiseasePompe & Pain - Observational Study to Assess Musculoskeletal Pain in Late-onset Pompe Disease (LOPD)Pompe Disease (Late-onset);Inclusion Body Myositis;Spinal Muscular Atrophy Type 3;FSHDDiagnostic Test: Beck depression inventory fast screen (Questionnaire);Diagnostic Test: Brief Pain Inventory (BPI) (Questionnaire);Diagnostic Test: German Pain Inventory (Questionnaire);Diagnostic Test: Fatigue Severity and Disability Scale (FSS) (Questionnaire);Diagnostic Test: Rotterdam Handicap Scale (RHS) (Questionnaire);Diagnostic Test: R-PAct (Questionnaire);Diagnostic Test: Quick Motor Function Test;Diagnostic Test: Handheld Dynamometry (HHD);Diagnostic Test: Six-minute walk test (6MWT);Diagnostic Test: Pressure pain threshold;Diagnostic Test: Muscle ultrasound;Diagnostic Test: Vital signs;Diagnostic Test: Borg Scale;Diagnostic Test: Laboratory assessment: Creatine kinase;Diagnostic Test: Laboratory assessment: Vitamin D Level;Diagnostic Test: Laboratory assessment: calcium;Diagnostic Test: Laboratory assessment: magnesium;Diagnostic Test: Laboratory assessment: phosphate;Genetic: Genetic test: ACE polymorphism;Genetic: Genetic test: ACTN3 polymorphism;Genetic: Blood draw for optional genetic exome sequencingLMU KlinikumNULLNot yet recruiting18 YearsN/AAll95Germany

6. パーキンソン病


臨床試験数 : 2,298 薬物数 : 2,202 - (DrugBank : 350) / 標的遺伝子数 : 188 - 標的パスウェイ数 : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01119131
(ClinicalTrials.gov)
May 201123/4/2010Effects of Vitamin D in Parkinson's Disease (PD)The Effects of Vitamin D on Balance in Persons With PDParkinson Disease;Accidental FallsDrug: Vitamin D3;Dietary Supplement: calcium;Other: PlaceboVA Office of Research and DevelopmentOregon Health and Science UniversityCompleted50 Years99 YearsAll101Phase 2United States

13. 多発性硬化症/視神経脊髄炎


臨床試験数 : 3,342 薬物数 : 2,355 - (DrugBank : 406) / 標的遺伝子数 : 269 - 標的パスウェイ数 : 241
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2021-000048-23-DE
(EUCTR)
03/03/202207/10/2021Study to test IMU-838 in patients with progressive multiple sclerosisMulticenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients with Progressive Multiple Sclerosis - CALLIPER Study Progressive forms of Multiple Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10053395;Term: Progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Immunic AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 2United States;Serbia;Czechia;Finland;Ukraine;North Macedonia;Russian Federation;Hungary;Canada;Poland;Romania;Bulgaria;Germany;Netherlands;Moldova, Republic of
2EUCTR2021-000048-23-NL
(EUCTR)
10/02/202212/10/2021Study to test IMU-838 in patients with progressive multiple sclerosisMulticenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients with Progressive Multiple Sclerosis - CALLIPER Study Progressive forms of Multiple Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10053395;Term: Progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Immunic AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 2Serbia;United States;Czechia;Finland;Ukraine;North Macedonia;Russian Federation;Hungary;Canada;Poland;Romania;Bulgaria;Netherlands;Germany;Moldova, Republic of
3EUCTR2021-000028-36-BG
(EUCTR)
18/01/202208/11/2021Not applicableA Multi-Center, Randomized, Double-Blinded Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 versus Placebo in Adults with Relapsing Multiple Sclerosis (ENSURE-1) - ENSURE-1 Relapsing Multiple Sclerosis
MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IMU-838
Product Name: Vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IMU-838
Immunic AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1050Phase 3United States;Belarus;Greece;Ukraine;Lithuania;North Macedonia;Russian Federation;Colombia;India;Mexico;Poland;Bulgaria;Albania;Georgia;Moldova, Republic of
4EUCTR2021-000048-23-BG
(EUCTR)
28/10/202128/09/2021Study to test IMU-838 in patients with progressive multiple sclerosisMulticenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients with Progressive Multiple Sclerosis - CALLIPER Study Progressive forms of Multiple Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10053395;Term: Progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Immunic AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 2Serbia;Czechia;Finland;Ukraine;North Macedonia;Russian Federation;Hungary;Poland;Romania;Bulgaria;Germany;Netherlands;Moldova, Republic of
5EUCTR2018-001896-19-BG
(EUCTR)
17/12/201811/10/2018Randomized, double-blind, placebo-controlled, multicenter Phase 2 trial assessing the effect of IMU-838 on disease activity, as measured by magnetic resonance imaging (MRI), as well as safety and tolerability in patients with relapsing-remitting multiple sclerosis (RRMS)Randomized, double-blind, placebo-controlled, multicenter Phase 2 trial assessing the effect of IMU-838 on disease activity, as measured by magnetic resonance imaging (MRI), as well as safety and tolerability in patients with relapsing-remitting multiple sclerosis (RRMS) - EMPhASIS relapsing-remitting multiple sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: VIDOFLUDIMUS CALCIUM
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Product Name: VIDOFLUDIMUS CALCIUM
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Immunic AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
195Phase 2Poland;Ukraine;Romania;Bulgaria
6NCT02636829
(ClinicalTrials.gov)
March 201617/11/2015Validation of Self-administered Questionnaire for Assessing Calcium Intake in Patients With Multiple Sclerosis or Chronic Inflammatory ArthritisValidation of Self-administered Questionnaire Specifically for Assessing Calcium Intake (QALCIMUM®) in Patients With Multiple Sclerosis (MS) or Chronic Inflammatory ArthritisMultiple Sclerosis;Rheumatoid ArthritisOther: QALCIMUM questionnaire;Other: Determination of calcium intake by a dietician interviewCentre Hospitalier Universitaire de NimesNULLCompleted18 Years69 YearsBoth100N/AFrance
7NCT01166178
(ClinicalTrials.gov)
October 201019/7/2010Zoledronic Acid in MS-patients With OsteoporosisA 1-year, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy of Zoledronic Acid 5 mg (Aclasta®) on Bone Mineral Density in Patients With Multiple Sclerosis Followed by a 1-year Open-label Treatment PhaseOsteoporosis;Multiple SclerosisDrug: Zoledronic Acid;Drug: Placebo;Dietary Supplement: Calcium and Vitamin D combinationNovartisNULLTerminated18 Years75 YearsAll29Phase 3Germany
8NCT00785473
(ClinicalTrials.gov)
January 20084/11/2008Can Vitamin D Supplementation Prevent Bone Loss in Persons With Multiple SclerosisCan Vitamin D Supplementation Prevent Bone Loss in Persons With MS? A Randomised, Placebo-controlled, Single-centre StudyMultiple Sclerosis, OsteoporosisDietary Supplement: cholecalciferol;Dietary Supplement: calcium carbonateUniversity Hospital of North NorwayNULLCompleted18 Years50 YearsBoth80Phase 4Norway
9NCT00644904
(ClinicalTrials.gov)
July 200624/3/2008Safety Trial of High Dose Oral Vitamin D3 With Calcium in Multiple SclerosisA Phase I/II Dose-Escalation Trial of Vitamin D3 With Calcium Supplementation in Patients With Multiple SclerosisMultiple SclerosisDietary Supplement: Vitamin D3University of TorontoDirect MS-Proactive Charity;Multiple Sclerosis Society of CanadaCompleted18 Years55 YearsBoth49Phase 1/Phase 2Canada
10EUCTR2005-006071-12-IT
(EUCTR)
31/08/200509/05/2006Evaluation of efficacy, safety and tolerability of an ADd-on therapy with Cianocabalamine Vitamin B12 plus Calcium levofolinate in relapsing-remitting multiple sclerosis patients Already in treatment with Nterferon beta over a period of 24 months for a better lonterm outComE - ADVANCEEvaluation of efficacy, safety and tolerability of an ADd-on therapy with Cianocabalamine Vitamin B12 plus Calcium levofolinate in relapsing-remitting multiple sclerosis patients Already in treatment with Nterferon beta over a period of 24 months for a better lonterm outComE - ADVANCE MULTIPLE SCLEROSIS
MedDRA version: 6.1;Level: PT;Classification code 10028245
Trade Name: EPARMEFOLIN 30 CPR 0,1/0,5MG
INN or Proposed INN: CALCIO FOLINATO DC.IT
INN or Proposed INN: CIANOCOBALAMINA FU DC.IT
Trade Name: LEVOFOLENE 4 MG 30 CPR
INN or Proposed INN: Calcium levofolinate
AZIENDA OSPEDALIERA SAN CAMILLO FORLANININULLNot RecruitingFemale: yes
Male: yes
276Italy

15. 封入体筋炎


臨床試験数 : 42 薬物数 : 60 - (DrugBank : 16) / 標的遺伝子数 : 12 - 標的パスウェイ数 : 123
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05272969
(ClinicalTrials.gov)
March 31, 202228/1/2022Pompe & Pain - Study to Assess Nociceptive Pain in Adult Patients With Pompe DiseasePompe & Pain - Observational Study to Assess Musculoskeletal Pain in Late-onset Pompe Disease (LOPD)Pompe Disease (Late-onset);Inclusion Body Myositis;Spinal Muscular Atrophy Type 3;FSHDDiagnostic Test: Beck depression inventory fast screen (Questionnaire);Diagnostic Test: Brief Pain Inventory (BPI) (Questionnaire);Diagnostic Test: German Pain Inventory (Questionnaire);Diagnostic Test: Fatigue Severity and Disability Scale (FSS) (Questionnaire);Diagnostic Test: Rotterdam Handicap Scale (RHS) (Questionnaire);Diagnostic Test: R-PAct (Questionnaire);Diagnostic Test: Quick Motor Function Test;Diagnostic Test: Handheld Dynamometry (HHD);Diagnostic Test: Six-minute walk test (6MWT);Diagnostic Test: Pressure pain threshold;Diagnostic Test: Muscle ultrasound;Diagnostic Test: Vital signs;Diagnostic Test: Borg Scale;Diagnostic Test: Laboratory assessment: Creatine kinase;Diagnostic Test: Laboratory assessment: Vitamin D Level;Diagnostic Test: Laboratory assessment: calcium;Diagnostic Test: Laboratory assessment: magnesium;Diagnostic Test: Laboratory assessment: phosphate;Genetic: Genetic test: ACE polymorphism;Genetic: Genetic test: ACTN3 polymorphism;Genetic: Blood draw for optional genetic exome sequencingLMU KlinikumNULLNot yet recruiting18 YearsN/AAll95Germany

19. ライソゾーム病


臨床試験数 : 854 薬物数 : 716 - (DrugBank : 105) / 標的遺伝子数 : 70 - 標的パスウェイ数 : 191
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00004488
(ClinicalTrials.gov)
October 199818/10/1999Phase II Randomized Study of Alendronate Sodium for Osteopenia in Patients With Gaucher's DiseaseGaucher's Disease;OsteopeniaDrug: alendronate sodium;Drug: calcium carbonate;Drug: cholecalciferolChildren's Hospital Medical Center, CincinnatiNULLCompleted18 Years50 YearsBoth82Phase 2United States;Israel

46. 悪性関節リウマチ


臨床試験数 : 4,325 薬物数 : 2,671 - (DrugBank : 417) / 標的遺伝子数 : 187 - 標的パスウェイ数 : 224
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02636829
(ClinicalTrials.gov)
March 201617/11/2015Validation of Self-administered Questionnaire for Assessing Calcium Intake in Patients With Multiple Sclerosis or Chronic Inflammatory ArthritisValidation of Self-administered Questionnaire Specifically for Assessing Calcium Intake (QALCIMUM®) in Patients With Multiple Sclerosis (MS) or Chronic Inflammatory ArthritisMultiple Sclerosis;Rheumatoid ArthritisOther: QALCIMUM questionnaire;Other: Determination of calcium intake by a dietician interviewCentre Hospitalier Universitaire de NimesNULLCompleted18 Years69 YearsBoth100N/AFrance
2NCT02944799
(ClinicalTrials.gov)
December 201527/6/2016Alendronate Treatment of Osteoporosis in Rheumatoid ArthritisAlendronate Treatment of Osteoporosis in Rheumatoid Arthritis - Indication and Duration: A Randomized, Double-blind, Placebocontrolled Study to Evaluate the Effects of Discontinuation of Alendronate in Patients With Both Rheumatoid Arthritis and Low Bone MassRheumatoid Arthritis;OsteoporosisDrug: Placebo;Drug: Alendronate;Drug: Calcium;Drug: Vitamin DUniversity of AarhusNULLActive, not recruiting18 YearsN/AAll69Phase 2Denmark
3NCT02894047
(ClinicalTrials.gov)
July 20135/9/2016Study of the Influence of the Expression of the Calcium-sensitive Receptor (CaSR) by Monocytes in the Synovial Liquid on Structural Alterations in Patients Diagnosed With Rheumatoid Arthritis in the Previous Two YearsStudy of the Influence of the Expression of the Calcium-sensitive Receptor (CaSR) by Monocytes in the Synovial Liquid on Structural Alterations in Patients Diagnosed With Rheumatoid Arthritis in the Previous Two YearsArthritis, RheumatoidBiological: bloodCentre Hospitalier Universitaire, AmiensNULLCompleted18 YearsN/ABoth42N/AFrance
4NCT01400516
(ClinicalTrials.gov)
August 201121/7/2011Teriparatide for Joint Erosions in Rheumatoid Arthritis: The TERA TrialTeriparatide for Joint Erosions in Rheumatoid Arthritis: The TERA TrialRheumatoid ArthritisDrug: Teriparatide;Drug: calcium citrate;Drug: Vitamin D;Drug: TNF antagonistBrigham and Women's HospitalEli Lilly and CompanyCompleted45 YearsN/AAll26Phase 4United States
5NCT00427804
(ClinicalTrials.gov)
January 200725/1/2007Tumor Necrosis Factor Decreases Vitamin D Dependant Calcium AbsorptionTumor Necrosis Factor-a Induces Vitamin D Resistance in Small Intestinal Calcium AbsorptionRheumatoid Arthritis;Crohn's DiseaseDrug: calcitriolAtlanta VA Medical CenterEmory UniversityCompleted18 Years50 YearsMale9N/AUnited States
6EUCTR2006-001359-36-NL
(EUCTR)
02/06/200629/03/2006Effects of low-dose aspirin taken at bedtime on pathophysiologic mechanisms underlying hypertension in subjects with grade 1 essential hypertension: the Aspirin In Reduction of Tension (ASPIRETENSION) study - ASPIRETENSIONEffects of low-dose aspirin taken at bedtime on pathophysiologic mechanisms underlying hypertension in subjects with grade 1 essential hypertension: the Aspirin In Reduction of Tension (ASPIRETENSION) study - ASPIRETENSION Patients should have grade 1 essential hypertension (140/90-159/99 mmHg), but free of history of any cardiovascular events, diabetes mellitus type 1 or 2 or rheumatoid arthritis.Trade Name: Ascal(r) / carbasalate calciumLeiden University Medical CenterNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
15Netherlands
7NCT00000429
(ClinicalTrials.gov)
June 199618/1/2000Calcium Supplements for Bone Health in Juvenile Rheumatoid ArthritisCalcium Supplementation for Bone Mineralization in Juvenile Rheumatoid Arthritis (JRA)Juvenile Rheumatoid ArthritisDrug: Calcium carbonateChildren's Hospital Medical Center, CincinnatiNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Completed6 Years18 YearsBoth192Phase 2United States
8NCT00570934
(ClinicalTrials.gov)
March 19957/12/2007Supplementation With Vitamin D, Calcium or Both on Calcium Absorption and Bone Mineral Content in Children With JRAEffect of Supplementation With 2000 International Units (IU) Vitamin D, 1gm Calcium or Both on Calcium Absorption and Bone Mineralization in Children With Juvenile Rheumatoid ArthritisJuvenile Rheumatoid ArthritisDietary Supplement: Cholecalciferol;Dietary Supplement: Calcium;Dietary Supplement: Calcium and cholecalciferol;Drug: PlaceboUniversity of Missouri-ColumbiaNULLCompleted3 Years15 YearsBoth24Phase 3United States

49. 全身性エリテマトーデス


臨床試験数 : 946 薬物数 : 722 - (DrugBank : 186) / 標的遺伝子数 : 117 - 標的パスウェイ数 : 199
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1ChiCTR-INR-17011495
2017-05-252017-05-26Canceled by the investigator The efficacy and safety of metformin hydrochloride combined with atorvastatin in the treatment of primary mild to moderate systemic syThe efficacy and safety of metformin hydrochloride combined with atorvastatin in the treatment of primary mild to moderate systemic systemic lupus erythematosus Primary mild to moderate systemic systemic lupus erythematosusImmunomodulatory treatment group:The level of SELSNA-SLEDAI was evaluated at week 4, week 12 and week 24, the BILAG table, the SLE lesion index, and the SLE damage index were measured at 4 weeks, 12 weeks and 24 weeks. The levels of Th17, Treg and Th17 / Treg were measured.;Leflunomide treatment group:Leflunomide tablets 10m, 1 times / day, orally. The SELSNA-SLEDAI score table, BILAG worksheet, SLE damage index score were assessed at week 4, week 12 and week 24, and serum Th17, Treg and Th17 / Treg ratios were measured.;Immunomodulatory treatment group and Leflunomide treatment group :0 weeks to give prednisone acetate tablets 0.5-1mg / kg.d (or patients can choose to take the same dose of methylprednisolone tablets), 4 weeks after the beginning of the dose by 2 weeks to reduce the regular dose of 10% Reduction to prednisone acetate tablets 10mg / day to maintain.;Immunomodulatory treatment group and Leflunomide treatment group:All patients without contraindications plus hydroxychloroquine tablets 0.2,2 / day, orally; and according to the condition plus calcium (800-1200mg / day), vitamin D (200-800IU / day) and other treatment.;The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and TechnologyNULLRecruitingBothImmunomodulatory treatment group:15;Leflunomide treatment group:15;Immunomodulatory treatment group and Leflunomide treatment group :30;Immunomodulatory treatment group and Leflunomide treatment group:30;China
2JPRN-jRCTs071180052
26/12/201415/03/2019Control of steroid-associated osteonecrosis of the femoral head in SLE patientsClinical trial for the control of osteonecrosis of the femoral head secondary to the initial corticosteroid treatment in patients with systemic lupus erythematosus - None systemic lupus erythematosus;D008180Objectives take three below candidate drugs for the prevention for at least 3 months after the initial corticosteroid treatment.
1. Clopidogrel Bisulfate (Plavix)
Taking a dose of 300mg once daily on the first day, and a dose of 75mg once daily on subsequent days.
2. Pitavastatin Calcium (LIVALO)
Taking a dose of 2mg once daily.
3. Tocopherol Acetate (Juvela)
Taking a dose of 100mg three times daily (total of 300mg daily).
Nakashima YasuharuNULLRecruiting>= 20age oldNot applicableBoth150Phase 2Japan
3JPRN-UMIN000008230
2014/08/0122/06/2012Clinical trial for the control of osteonecrosis of the femoral head secondary to the initial corticosteroid treatment in patients with systemic lupus erythematosus Systemic lupus erythematosusObjectives take three below candidate drugs for the prevention for at least 3 months after the initial corticosteroid treatment.
1. Clopidgrel Bisulfate (Plavix)
Taking a dose of 300mg once daily on the first day, and a dose of 75mg once daily on subsequent days.
2. Pitavastatin Calcium (LIVALO)
Taking a dose of 2mg once daily.
3. Tocopherol Acetate (Juvela)
Taking a dose of 100mg three times daily (total of 300mg daily).
Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kyushu UniversityNULLRecruiting20years-oldNot applicableMale and Female150Phase 2Japan
4EUCTR2010-023645-29-DE
(EUCTR)
15/03/201111/01/2011Efficacy and safety of fumaric acid esters in the treatment of patients with cutaneous lupus erythematosus: A monocentre, open-label, prospective pilot study - FumaCLEEfficacy and safety of fumaric acid esters in the treatment of patients with cutaneous lupus erythematosus: A monocentre, open-label, prospective pilot study - FumaCLE Adult subjects of any ethnicity and either gender with Cutaneous Lupus Erythematosus lesions of Subacute Cutaneous Lupus Erythematosus (SCLE), Discoid Lupus Erythematosus (DLE), Lupus erythematosus tumidus (LET) or Systemic Lupus Erythematosus (SLE) with DLE or SCLE lesions and without major organ involvement to investigate the efficacy of fumaric acid esters in the treatment of Cutaneous Lupus Erythematosus lesions.
MedDRA version: 12.1;Level: LLT;Classification code 10056509;Term: Cutaneous lupus erythematosus
MedDRA version: 12.1;Level: PT;Term: Cutaneous lupus erythematosus
Trade Name: Fumaderm® initial
Product Name: -
Product Code: -
INN or Proposed INN: Dimethylfumarat
INN or Proposed INN: Ethylhydrogenfumarat, Calciumsalz
INN or Proposed INN: Ethylhydrogenfumarat, Magnesiumsalz
INN or Proposed INN: Ethylhydrogenfumarat, Zinksalz
Trade Name: Fumaderm®
Product Name: -
Product Code: -
INN or Proposed INN: Dimethylfumarat
INN or Proposed INN: Ethylhydrogenfumarat, Calciumsalz
INN or Proposed INN: Ethylhydrogenfumarat, Magnesiumsalz
INN or Proposed INN: Ethylhydrogenfumarat, Zinksalz
Universitätsklinikum MünsterNULLNot RecruitingFemale: yes
Male: yes
11Germany
5EUCTR2006-006214-16-GB
(EUCTR)
23/02/201029/02/2008A randomised placebo controlled trial of rosuvastatin in systemic lupus erythematosus. - RCT of statin in SLEA randomised placebo controlled trial of rosuvastatin in systemic lupus erythematosus. - RCT of statin in SLE Systemic lupus erythematosus.
MedDRA version: 13.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: Crestor
Product Name: Crestor
INN or Proposed INN: ROSUVASTATIN CALCIUM
Other descriptive name: rosuvastatin
Trade Name: Crestor
Product Name: Crestor
INN or Proposed INN: ROSUVASTATIN CALCIUM
Other descriptive name: rosuvastatin
Imperial CollegeNULLNot Recruiting Female: yes
Male: yes
64 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom
6NCT00668330
(ClinicalTrials.gov)
April 200725/4/2008Steroid Induced Osteoporosis in Patients With Systemic Lupus ErythematosusSteroid Induced Osteoporosis in Patients With Systemic Lupus Erythematosus-Prevalence,Risk Factors and TreatmentSystemic Lupus ErythematosusDrug: Ibandronate+alfacalcidol+calcium;Drug: placebo ibandronate+alfacalcidol+calciumChinese University of Hong KongNULLCompleted18 Years80 YearsFemale40Phase 4China

51. 全身性強皮症


臨床試験数 : 523 薬物数 : 608 - (DrugBank : 156) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 215
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02642146
(ClinicalTrials.gov)
January 201524/12/2015Treatment of Digital Ulcers in Korean Patients With Systemic Sclerosis: a Prospective Cohort StudyRaynaud Disease;Systemic Sclerosis;Digital UlcerDrug: Calcium Channel Blockers;Drug: Phosphodiesterase Inhibitors;Drug: Endothelin receptor blocker;Drug: Prostanoids;Drug: Other vasodilatorSeoul National University HospitalNULLTerminated18 YearsN/AAll71Korea, Republic of

53. シェーグレン症候群


臨床試験数 : 283 薬物数 : 320 - (DrugBank : 101) / 標的遺伝子数 : 56 - 標的パスウェイ数 : 181
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02370550
(ClinicalTrials.gov)
March 201518/2/2015Cyclosporine A in the TReatment of Interstitial Pneumonitis Associated With Sjogren's SyndromeCyclosporine A in the TReatment of Interstitial Pneumonitis Associated With Sjogren's Syndrome(CTRIPS): A Prospective, Randomized, Multicenter, Double-Blind Placebo-Controlled TrialSjogren's SyndromeDrug: Cyclosporin A;Drug: Prednisone;Drug: Placebo;Drug: Calcium carbonate DPeking University People's HospitalNULLRecruiting18 Years75 YearsAll240Phase 4China

56. ベーチェット病


臨床試験数 : 76 薬物数 : 110 - (DrugBank : 32) / 標的遺伝子数 : 36 - 標的パスウェイ数 : 116
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04328064
(ClinicalTrials.gov)
May 201029/8/2011The Role of Rosuvastatin on Vascular Involvement in Behçet's DiseaseBehcet's DiseaseDrug: Rosuvastatin calcium 40mg;Drug: Placebo oral tabletUniversity of AlexandriaNULLCompleted17 Years65 YearsAll56N/ANULL

68. 黄色靱帯骨化症


臨床試験数 : 2 薬物数 : 4 - (DrugBank : 4) / 標的遺伝子数 : 1 - 標的パスウェイ数 : 3
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1ChiCTR1800018858
2018-10-012018-10-14Alterations of Serum Inflammatory Cytokines in Postmenopausal Osteoporosis Patients Treated with Human Parathyroid Hormone (1–34)Research in Molecular network and mechanism of chondrocytes miR24 associated with osteogenesis in senile ossification of ligamentum flavum osteoporosis fractureCase series:Daily subcutaneous injections of teriparatide (PTH1-34)20ug,plus daily oral calcium 1000 mg and vitamin D 800 IU;General Hospital of Tianjin Medical UniversityNULLPending5090FemaleCase series:50;China

75. クッシング病


臨床試験数 : 203 薬物数 : 191 - (DrugBank : 51) / 標的遺伝子数 : 62 - 標的パスウェイ数 : 128
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2008-002280-14-FR
(EUCTR)
18/07/200806/06/2008Comparative study of the effect of 4-week treatment with ossein-hydroxyapatite compound versus calcium carbonate on bone biomarkers in young women with low calcium intake. Prospective, monocenter, randomized, open-label, two-period,cross-over trialComparative study of the effect of 4-week treatment with ossein-hydroxyapatite compound versus calcium carbonate on bone biomarkers in young women with low calcium intake. Prospective, monocenter, randomized, open-label, two-period,cross-over trial The Active substance of Osteopor is Ossein Hydroxyapatite.Treatment of processes characterized by decalcification: osteoporosis, Cushing syndrome, thyrotoxicosis.
MedDRA version: 9.1;Level: LLT;Classification code 10006956;Term: Calcium deficiency
Trade Name: OSTEOPOR
Product Name: OSTEOPOR
Product Code: L0006CP03A
INN or Proposed INN: ossein hydroxyapatite
Trade Name: OROCAL
Product Name: OROCAL
INN or Proposed INN: calcium carbonate
Pierre Fabre MédicamentNULLNot RecruitingFemale: yes
Male: no
60Phase 3France

79. 家族性高コレステロール血症(ホモ接合体)


臨床試験数 : 142 薬物数 : 114 - (DrugBank : 29) / 標的遺伝子数 : 9 - 標的パスウェイ数 : 18
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2014-004746-99-DK
(EUCTR)
27/03/201527/03/2015A study to evluate the safety of Rosuvastatin in Children and Adolescents with Homozygous Familial Hypercholesterolemia.An Open-Label Long-Term Extension to the Randomized, Double-blind, Placebo-controlled, Multi-center, Cross-over Study of Rosuvastatin in Children and Adolescents (aged 6 to <18 years) with Homozygous Familial Hypercholesterolemia (HoFH) Hypercholesterolemia - The current trial will study children with Homozygous Familial Hypercholesterolemia (HoFH).
MedDRA version: 19.0;Level: LLT;Classification code 10054380;Term: Familial hypercholesterolemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Crestor Film-Coated Tablet
Product Name: Crestor
Product Code: ZD4522
INN or Proposed INN: Rosuvastatin calcium
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
20Phase 3United States;Taiwan;Canada;Malaysia;Belgium;Lebanon;Denmark;Israel;Netherlands;Germany;Sweden
2EUCTR2014-004746-99-BE
(EUCTR)
23/02/201518/12/2014A study to evluate the safety of Rosuvastatin in Children and Adolescents with Homozygous Familial Hypercholesterolemia.An Open-Label Long-Term Extension to the Randomized, Double-blind, Placebo-controlled, Multi-center, Cross-over Study of Rosuvastatin in Children and Adolescents (aged 6 to <18 years) with Homozygous Familial Hypercholesterolemia (HoFH) Hypercholesterolemia - The current trial will study children with Homozygous Familial Hypercholesterolemia (HoFH).;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]Trade Name: Crestor Film-Coated Tablet
Product Name: Crestor
Product Code: ZD4522
INN or Proposed INN: Rosuvastatin calcium
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
20Phase 3United States;Taiwan;Canada;Malaysia;Belgium;Lebanon;Denmark;Israel;Netherlands;Germany;Sweden
3EUCTR2014-000972-24-DK
(EUCTR)
17/12/201425/09/2014A study to evaluate the effect of Rosuvastatin on fatty acids in Children and Adolescents with Homozygous Familial HypercholesterolemiaA Randomized, Double blind, Placebo controlled, Multi center, Cross over Study of Rosuvastatin in Children and Adolescents (aged 6 to <18 years) with Homozygous Familial Hypercholesterolemia (HoFH) - HYDRA Hypercholesterolemia - The current trial will study children with Homozygous Familial Hypercholesterolemia (HoFH)
MedDRA version: 17.0;Level: LLT;Classification code 10054380;Term: Familial hypercholesterolemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Crestor Tablets (calcium rosuvastatin) Film-Coated tablets
Product Name: Crestor
Product Code: ZD4522
INN or Proposed INN: calcium rosuvastatin
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
25United States;Taiwan;Canada;Malaysia;Belgium;Lebanon;Denmark;Israel;Germany;Netherlands;Sweden
4EUCTR2014-000972-24-DE
(EUCTR)
17/11/201426/09/2014A study to evaluate the effect of Rosuvastatin on fatty acids in Children and Adolescents with Homozygous Familial HypercholesterolemiaA Randomized, Double blind, Placebo controlled, Multi center, Cross over Study of Rosuvastatin in Children and Adolescents (aged 6 to <18 years) with Homozygous Familial Hypercholesterolemia (HoFH) - HYDRA Hypercholesterolemia - The current trial will study children with Homozygous Familial Hypercholesterolemia (HoFH)
MedDRA version: 17.1;Level: LLT;Classification code 10054380;Term: Familial hypercholesterolemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Crestor Tablets (calcium rosuvastatin) Film-Coated tablets
Product Name: Crestor
Product Code: ZD4522
INN or Proposed INN: calcium rosuvastatin
Trade Name: Crestor Tablets (calcium rosuvastatin) Film-Coated tablets
Product Name: Crestor
Product Code: ZD4522
INN or Proposed INN: calcium rosuvastatin
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
25United States;Taiwan;Hong Kong;Israel;United Kingdom;Czech Republic;Belgium;Denmark;Australia;South Africa;Germany;Netherlands;Norway;Sweden
5EUCTR2014-000972-24-BE
(EUCTR)
27/10/201411/09/2014A study to evaluate the effect of Rosuvastatin on fatty acids in Children and Adolescents with Homozygous Familial HypercholesterolemiaA Randomized, Double blind, Placebo controlled, Multi center, Cross over Study of Rosuvastatin in Children and Adolescents (aged 6 to <18 years) with Homozygous Familial Hypercholesterolemia (HoFH) - HYDRA Hypercholesterolemia - The current trial will study children with Homozygous Familial Hypercholesterolemia (HoFH)
MedDRA version: 17.1;Level: LLT;Classification code 10054380;Term: Familial hypercholesterolemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Crestor Tablets (calcium rosuvastatin) Film-Coated tablets
Product Name: Crestor
Product Code: ZD4522
INN or Proposed INN: calcium rosuvastatin
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
25Phase 3United States;Taiwan;Hong Kong;Israel;United Kingdom;Czech Republic;Belgium;Australia;Denmark;South Africa;Germany;Netherlands;Norway;Sweden
6EUCTR2014-000972-24-NL
(EUCTR)
20/10/201405/08/2014A study to evaluate the effect of Rosuvastatin on fatty acids in Children and Adolescents with Homozygous Familial HypercholesterolemiaA Randomized, Double blind, Placebo controlled, Multi center, Cross over Study of Rosuvastatin in Children and Adolescents (aged 6 to <18 years) with Homozygous Familial Hypercholesterolemia (HoFH) - HYDRA Hypercholesterolemia - The current trial will study children with Homozygous Familial Hypercholesterolemia (HoFH)
MedDRA version: 17.1;Level: LLT;Classification code 10054380;Term: Familial hypercholesterolemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Crestor Tablets (calcium rosuvastatin) Film-Coated tablets
Product Name: Crestor
Product Code: ZD4522
INN or Proposed INN: calcium rosuvastatin
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
25United States;Taiwan;Hong Kong;Israel;United Kingdom;Czech Republic;Belgium;Australia;Denmark;South Africa;Germany;Netherlands;Norway;Sweden
7EUCTR2014-000972-24-SE
(EUCTR)
20/08/201430/06/2014A study to evaluate the effect of Rosuvastatin on fatty acids in Children and Adolescents with Homozygous Familial HypercholesterolemiaA Randomized, Double blind, Placebo controlled, Multi center, Cross over Study of Rosuvastatin in Children and Adolescents (aged 6 to <18 years) with Homozygous Familial Hypercholesterolemia (HoFH) - HYDRA Hypercholesterolemia - The current trial will study children with Homozygous Familial Hypercholesterolemia (HoFH)
MedDRA version: 17.1;Level: LLT;Classification code 10054380;Term: Familial hypercholesterolemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Crestor Tablets (calcium rosuvastatin) Film-Coated tablets
Product Name: Crestor
Product Code: ZD4522
INN or Proposed INN: calcium rosuvastatin
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
25United States;Taiwan;Hong Kong;Israel;United Kingdom;Czech Republic;Belgium;Australia;Denmark;South Africa;Germany;Netherlands;Norway;Sweden
8EUCTR2014-004746-99-SE
(EUCTR)
23/12/2014A study to evluate the safety of Rosuvastatin in Children and Adolescents with Homozygous Familial Hypercholesterolemia.An Open-Label Long-Term Extension to the Randomized, Double-blind, Placebo-controlled, Multi-center, Cross-over Study of Rosuvastatin in Children and Adolescents (aged 6 to <18 years) with Homozygous Familial Hypercholesterolemia (HoFH) Hypercholesterolemia - The current trial will study children with Homozygous Familial Hypercholesterolemia (HoFH).;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]Trade Name: Crestor Film-Coated Tablet
Product Name: Crestor
Product Code: ZD4522
INN or Proposed INN: Rosuvastatin calcium
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
20Phase 3United States;Taiwan;Canada;Malaysia;Belgium;Lebanon;Denmark;Israel;Netherlands;Germany;Sweden

84. サルコイドーシス


臨床試験数 : 149 薬物数 : 227 - (DrugBank : 81) / 標的遺伝子数 : 82 - 標的パスウェイ数 : 167
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02155803
(ClinicalTrials.gov)
February 201530/5/2014ACTHAR GEL for Sarcoidosis-Associated Calcium Dysregulation: An Open-label Pilot StudyACTHAR GEL for Sarcoidosis-Associated Calcium Dysregulation: An Open-label Pilot StudySarcoidosis;Hypercalcemia Due to SarcoidosisDrug: ACTHAR Gel (adrenocorticotropic hormone)Albany Medical CollegeNULLNot yet recruiting18 YearsN/ABoth10Phase 2/Phase 3United States
2NCT03621553
(ClinicalTrials.gov)
July 1, 201017/7/2018Vitamin D Homeostasis in SarcoidosisVitamin D Homeostasis in SarcoidosisSarcoidosis;Vitamin D InsufficiencyDrug: Ergocalciferol;Drug: Placebo;Drug: Calcium Citrate with Vitamin D2University of Texas Southwestern Medical CenterNULLActive, not recruiting21 YearsN/AAll90Phase 4United States

93. 原発性胆汁性胆管炎


臨床試験数 : 282 薬物数 : 245 - (DrugBank : 56) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 113
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-UMIN000012489
2013/12/0404/12/2013Efficacy of anti-RANKL human antibody (Denosumab) on prevention of osteoporosis with primary biliary cirrhosis Osteoporosis in biopsy-proven PBC who was not pretreated with denosumab and/or bisphosphonate in recent 6 monthsFor osteoporosis patients who need treatment based on PBC treatment guideline, 60mg of denosumab will be subcutaneously injected every 6 months for 12 months. All patients will take activated vitamin D. In the case of hypocalcemia, calcium will be administrated appropriately. PBC patients who do not meet osteoporosis treatment criteria will be followed.Juntendo University School of MedicineNULLComplete: follow-up continuing20years-oldNot applicableMale and Female20Not applicableJapan
2JPRN-UMIN000012193
2013/11/0101/11/2013Efficacy of the anti-RANKL human antibody (Denosumab) versus Bisphosphonate for the treatment of osteoporosis in patients with primary biliary cirrhosis Osteoporosis in biopsy-proven primary biliary cirrhosis patients pretreated with bisphosphonateDiscontinue the administration of aredoron acid, risedronic acid, and minodronic acid. Then, 60mg of denosumab will be subcutaneously injected every 6 months for 12 months. All patients will take activated vitamin D. In the case of hypocalcemia, calcium will be administrated appropriately.
Continue the administration of bisphosphonate as heretofore. All patients will take activated vitamin D.
Juntendo University School of MedicineNULLComplete: follow-up complete20years-oldNot applicableMale and Female60Not applicableJapan

94. 原発性硬化性胆管炎


臨床試験数 : 142 薬物数 : 113 - (DrugBank : 37) / 標的遺伝子数 : 19 - 標的パスウェイ数 : 139
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03722576
(ClinicalTrials.gov)
June 17, 201925/10/2018Vidofludimus Calcium for Primary Sclerosing CholangitisInvestigation of the Activity of Vidofludimus Calcium, a Novel, Orally Available, Small Molecule Inhibitor of Dihydroorotate Dehydrogenase, as a Treatment for Primary Sclerosing Cholangitis (PSC)Primary Sclerosing CholangitisDrug: Vidofludimus calciumElizabeth CareyArizona State UniversityCompleted18 Years75 YearsAll14Phase 2United States

95. 自己免疫性肝炎


臨床試験数 : 52 薬物数 : 68 - (DrugBank : 28) / 標的遺伝子数 : 19 - 標的パスウェイ数 : 112
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-UMIN000013659
2014/04/0808/04/2014Efficacy of a human anti-RANKL antibody (Denosumab) on prevention of steroid-induced osteoporosis in patients with autoimmune hepatitis (AIH) Biopsy-proven AIH patients who are planned or undergoing oral steroid therapy for more than 3 months<Test A; Randomization test: 1)2)>
In patients pretreated with bisphosphonates;
1) Discontinue the administration of aredoron acid, risedronic acid, or minodronic acid. Then, 60mg of denosumab will be subcutaneously injected every 6 months for 12 months. All patients will take activated vitamin D. In the case of hypocalcemia, calcium will be administrated appropriately.

<Test A; Randomization test: 1)2)>
2) Continue the administration of bisphosphonate as heretofore. All patients will take activated vitamin D.

<Test B; newly intervention>
In patients who were not pretreated with bisphosphonates; 60mg of denosumab will be subcutaneously injected every 6 months for 12 months. All patients will take activated vitamin D. In the case of hypocalcemia, calcium will be administrated appropriately.
Juntendo University School of MedicineNULLComplete: follow-up continuing20years-old75years-oldMale and Female80Not applicableJapan

96. クローン病


臨床試験数 : 2,400 薬物数 : 1,391 - (DrugBank : 267) / 標的遺伝子数 : 170 - 標的パスウェイ数 : 215
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-001895-39-HR
(EUCTR)
21/11/201920/01/2020A phase 2 Dose-finding study of IMU-838 in patients with active Crohn’s diseaseA phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding trial to evaluate the efficacy and safety of IMU-838 for treatment of patients with active Crohn’s disease with an option for open-label treatment extension (CALDOSE-2) - CALDOSE-2 Crohn’s disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Immunic AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
258 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;United States;Slovenia;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Poland;Croatia;Romania;Bulgaria;Germany;Netherlands
2EUCTR2018-001895-39-NL
(EUCTR)
27/09/201903/06/2019A phase 2 Dose-finding study of IMU-838 in patients with active Crohn’s diseaseA phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding trial to evaluate the efficacy and safety of IMU-838 for treatment of patients with active Crohn’s disease with an option for open-label treatment extension (CALDOSE-2) - CALDOSE-2 Crohn’s disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Immunic AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
258 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;United States;Slovenia;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Poland;Croatia;Romania;Bulgaria;Netherlands;Germany
3EUCTR2018-001895-39-BG
(EUCTR)
05/09/201916/07/2019A phase 2 Dose-finding study of IMU-838 in patients with active Crohn’s diseaseA phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding trial to evaluate the efficacy and safety of IMU-838 for treatment of patients with active Crohn’s disease with an option for open-label treatment extension (CALDOSE-2) - CALDOSE-2 Crohn’s disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Immunic AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
258 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;United States;Slovenia;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Poland;Croatia;Romania;Bulgaria;Germany;Netherlands
4EUCTR2018-001895-39-CZ
(EUCTR)
06/06/201905/03/2019A phase 2 Dose-finding study of IMU-838 in patients with active Crohn’s diseaseA phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding trial to evaluate the efficacy and safety of IMU-838 for treatment of patients with active Crohn’s disease with an option for open-label treatment extension (CALDOSE-2) - CALDOSE-2 Crohn’s disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Immunic AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
258Phase 2United States;Serbia;Slovenia;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Poland;Croatia;Romania;Bulgaria;Germany;Netherlands
5NCT02704624
(ClinicalTrials.gov)
December 201624/2/2016Effects of Supplementation of Vitamin D in Patients With Crohn's DiseaseThe Impact of Serum Vitamin D and Calcium Levels on the Body Composition, Bone Mineral Density, Muscle Strength, Exercise Tolerance, Fatigue and Inflammatory Activity in Patients With Crohn's Disease: a Randomized Controlled TrialCrohn Disease;Vitamin D Deficiency;Fatigue;Sarcopenia;Muscle Weakness;Disorder of Bone Density and Structure, UnspecifiedDietary Supplement: Vitamin D;Other: PlaceboFederal University of Juiz de ForaFundação de Amparo à Pesquisa do estado de Minas GeraisEnrolling by invitation18 Years50 YearsAll110Phase 4Brazil
6NCT01735461
(ClinicalTrials.gov)
December 201222/11/2012Calcium Supplements Strategy for Kidney Stones Prevention in Crohn's PatientsOral Calcium Supplementation, a Strategy to Reduce Kidney Stones in Crohn's Patients Living With a Small Bowel ResectionKidney Calculi;Crohn's DiseaseDietary Supplement: Calcium CarbonateUniversity of British ColumbiaUniversity of Texas Southwestern Medical CenterRecruiting19 YearsN/AAll40N/ACanada
7NCT01215890
(ClinicalTrials.gov)
September 20105/10/2010Risedronate Therapy in the Treatment of Low Bone Mineral Density in Crohn's DiseaseA Randomized, Data Collection Program To Determine the Efficacy and Safety of Risedronate (Actonel) Therapy Plus Calcium and Vitamin D Supplementation Versus Placebo Plus Calcium and Vitamin D Supplementation in the Treatment of Low Bone Mineral Density in Crohn's Disease PatientsCrohn's Disease;Low Bone Mineral DensityDrug: risedronate;Drug: placeboUniversity of AlbertaNULLCompleted18 YearsN/ABothPhase 4Canada
8NCT00427804
(ClinicalTrials.gov)
January 200725/1/2007Tumor Necrosis Factor Decreases Vitamin D Dependant Calcium AbsorptionTumor Necrosis Factor-a Induces Vitamin D Resistance in Small Intestinal Calcium AbsorptionRheumatoid Arthritis;Crohn's DiseaseDrug: calcitriolAtlanta VA Medical CenterEmory UniversityCompleted18 Years50 YearsMale9N/AUnited States

97. 潰瘍性大腸炎


臨床試験数 : 2,527 薬物数 : 1,465 - (DrugBank : 259) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04767984
(ClinicalTrials.gov)
September 24, 202123/2/2021Testing Atorvastatin to Lower Colon Cancer Risk in Longstanding Ulcerative ColitisA Randomized and Placebo-Controlled Phase II Trial Targeting Dominant-Negative Missense Mutant P53 by Atorvastatin for Reducing the Risk of Longstanding Ulcerative Colitis-Associated CancerColorectal Carcinoma;Ulcerative ColitisDrug: Atorvastatin Calcium;Procedure: Biospecimen Collection;Drug: Placebo AdministrationNational Cancer Institute (NCI)NULLRecruiting18 Years70 YearsAll70Phase 2United States
2EUCTR2019-004208-37-BE
(EUCTR)
03/08/202004/03/2020Statins for treating ulcerative colitis through GI microbiomeDrug repurposing - Statins as microbiota modulating agents in ulcerative colitis - ReMiDy There are two population groups, 20 healthy volunteers and at least 150 individuals diagnosed with mild/moderate active ulcerative colitis or are in remission.;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Rosuvastatine EG
Product Name: rosuvastatin
INN or Proposed INN: rosuvastatin
Other descriptive name: ROSUVASTATIN CALCIUM
UZ LeuvenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 3Belgium
3EUCTR2017-003703-22-BG
(EUCTR)
07/04/202006/02/2020Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)A phase 2, multicenter, randomized, double-blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of IMU 838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1 Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Immunic AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 2United States;Serbia;Belarus;Portugal;Czechia;Spain;Ukraine;Russian Federation;North Macedonia;United Kingdom;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Netherlands;Bosnia and Herzegovina
4EUCTR2017-003703-22-PT
(EUCTR)
02/03/202018/12/2019Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)A phase 2, multicenter, randomized, double-blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of IMU 838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1 Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Immunic AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 2Portugal;Belarus;Serbia;United States;Czechia;Spain;Ukraine;North Macedonia;Russian Federation;United Kingdom;Poland;Belgium;Romania;Croatia;Bulgaria;Germany;Netherlands;Bosnia and Herzegovina
5EUCTR2017-003703-22-HR
(EUCTR)
20/11/201913/01/2020Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)A phase 2, multicenter, randomized, double-blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of IMU 838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1 Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Immunic AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 2Bosnia and Herzegovina;Netherlands;Germany;Bulgaria;Romania;Croatia;Poland;Belgium;United Kingdom;Russian Federation;North Macedonia;Ukraine;Spain;Czechia;Portugal;Belarus;Serbia;United States
6EUCTR2017-003703-22-PL
(EUCTR)
25/04/201926/04/2018Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)A phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding study to evaluate the efficacy and safety of IMU-838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1 Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Immunic AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 2Portugal;Belarus;Serbia;United States;Czechia;Spain;Ukraine;North Macedonia;Russian Federation;United Kingdom;Poland;Belgium;Romania;Croatia;Bulgaria;Germany;Netherlands;Bosnia and Herzegovina
7EUCTR2017-003703-22-NL
(EUCTR)
24/07/201805/03/2018Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)A phase 2, multicenter, randomized, double-blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of IMU 838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1 Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Immunic AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 2Portugal;Belarus;Serbia;United States;Czechia;Spain;Ukraine;North Macedonia;Russian Federation;United Kingdom;Belgium;Poland;Romania;Croatia;Bulgaria;Netherlands;Germany;Bosnia and Herzegovina
8EUCTR2017-003703-22-GB
(EUCTR)
03/05/201831/01/2018Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)A phase 2, multicenter, randomized, double-blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of IMU 838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1 Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium dihydrate
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium dihydrate
Other descriptive name: IM90838
Immunic AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 2Serbia;Portugal;United States;Belarus;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Macedonia, the former Yugoslav Republic of;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Netherlands;Bosnia and Herzegovina
9EUCTR2017-003703-22-ES
(EUCTR)
29/04/201820/02/2018Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)A phase 2, multicenter, randomized, double-blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of IMU 838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1 Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Immunic AGNULLNot Recruiting Female: yes
Male: yes
210 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;United States;Czech Republic;Slovakia;Poland;Belgium;Spain;Ukraine;Russian Federation;Netherlands;Germany;United Kingdom

186. ロスムンド・トムソン症候群


臨床試験数 : 1 薬物数 : 2 - (DrugBank : 1) / 標的遺伝子数 : 0 - 標的パスウェイ数 : 0
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01304407
(ClinicalTrials.gov)
March 201123/2/2011Calcium Absorption in Patients With Rothmund-Thomson SyndromeEvaluation of Calcium Absorption in Patients With Rothmund-Thomson SyndromeRothmund-Thomson SyndromeOther: Calcium stable isotopeBaylor College of MedicineUnited States Department of Agriculture (USDA);National Institutes of Health (NIH);National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);Gillson-Longenbaugh FoundationCompleted4 YearsN/AAll29N/AUnited States

214. 心室中隔欠損を伴う肺動脈閉鎖症


臨床試験数 : 2 薬物数 : 4 - (DrugBank : 4) / 標的遺伝子数 : 0 - 標的パスウェイ数 : 0
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00004361
(ClinicalTrials.gov)
July 199518/10/1999Study of the Relationship Between Calcium Levels and Intact Parathyroid Hormone (iPTH) in Adults With Repaired or Palliated Conotruncal Cardiac DefectsHypoparathyroidism;Tetralogy of Fallot;Pulmonary Valve Stenosis;Conotruncal Cardiac Defects;Heart Defects, Congenital;Pulmonary AtresiaDrug: calcium gluconate;Drug: sodium citrateNational Center for Research Resources (NCRR)Ann & Robert H Lurie Children's Hospital of ChicagoCompleted18 YearsN/ABoth150N/ANULL

215. ファロー四徴症


臨床試験数 : 22 薬物数 : 48 - (DrugBank : 19) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 49
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00004361
(ClinicalTrials.gov)
July 199518/10/1999Study of the Relationship Between Calcium Levels and Intact Parathyroid Hormone (iPTH) in Adults With Repaired or Palliated Conotruncal Cardiac DefectsHypoparathyroidism;Tetralogy of Fallot;Pulmonary Valve Stenosis;Conotruncal Cardiac Defects;Heart Defects, Congenital;Pulmonary AtresiaDrug: calcium gluconate;Drug: sodium citrateNational Center for Research Resources (NCRR)Ann & Robert H Lurie Children's Hospital of ChicagoCompleted18 YearsN/ABoth150N/ANULL

222. 一次性ネフローゼ症候群


臨床試験数 : 285 薬物数 : 285 - (DrugBank : 108) / 標的遺伝子数 : 62 - 標的パスウェイ数 : 191
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01508468
(ClinicalTrials.gov)
January 17, 20129/12/2011Evaluate Rituximab Treatment for Idiopathic Membranous NephropathyProspective Randomized Multicentric Open Label Study to Evaluate Rituximab Treatment for Idiopathic Membranous Nephropathy (IMN)Idiopathic Membranous NephropathyDrug: symptomatic treatment (Converting Enzyme inhibitor, Angiotensin II, Anti-renin, Aldosterone antagonist diuretic, Beta blocker, Calcium inhibitor, statin);Drug: experimental (Non Immunosuppressive Symptomatic Treatment (NIST) and Rituximab)Assistance Publique - Hôpitaux de ParisNULLCompleted18 YearsN/AAll80Phase 3France

224. 紫斑病性腎炎


臨床試験数 : 13 薬物数 : 42 - (DrugBank : 20) / 標的遺伝子数 : 15 - 標的パスウェイ数 : 57
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03591471
(ClinicalTrials.gov)
September 20149/12/2014Study on Children Henoch-Schönlein Purpura Nephritis With TCM Multistep TreatmentDemonstrated Study on Children Henoch-Schönlein Purpura Nephritis With Multistep Treatment of Traditional Chinese Medicine Combined Disease and Syndrome DifferentiationHenoch-Schönlein Purpura NephritisDrug: Glycosides Of Tripterygium Wilfordii Hook(GTW);Drug: Sulfotanshinone Sodium Injection;Drug: Chinese herbs based on syndrome differentiation;Drug: Prednisone Acetate Tablets;Drug: Benazepril Hydrochloride Tablets;Drug: Low Molecular Weight Heparin Calcium Injection;Drug: Dipyridamole Tab 25 MG;Drug: Chinese medicine placeboHenan University of Traditional Chinese MedicinePeking University First Hospital;Children's Hospital of Fudan University;Shanghai Children's Hospital;Chengdu University of Traditional Chinese Medicine;Affiliated Hospital of Yunnan University of Traditional Chinese MedicineUnknown status2 Years18 YearsAll500Phase 1/Phase 2China

235. 副甲状腺機能低下症


臨床試験数 : 88 薬物数 : 128 - (DrugBank : 25) / 標的遺伝子数 : 5 - 標的パスウェイ数 : 7
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1ChiCTR2100041719
2021-01-042021-01-02A clinical study of efficacy and safety for PTH recombinant plasmid and PTH rhMSC therapy in the patients with hypoparathyroidismA clinical study of efficacy and safety for PTH recombinant plasmid and PTH rhMSC therapy in the patients with hypoparathyroidism hypoparathyroidismPTH naked plasmid-1:PTH naked plasmid 500 µg,/kg,ih+Calcium agent;PTH naked plasmid-2:PTH naked plasmid 300 µg,/kg,ih+Calcium agent;PTH naked plasmid-3:PTH naked plasmid 100 µg,/kg,ih+Calcium agent;PTH-rhMSC-1:PTH-rhMSC 10^6/ kg,ih+Calcium agent;PTH-rhMSC-2:PTH-rhMSC 10^7/ kg,ih+Calcium agent;PTH-rhMSC-3:PTH-rhMSC 10^8/ kg,ih+Calcium agent;Calcium agent therapy control:Calcium +Calcitriol;pcDNA3.1 control:pcDNA3.1 +Calcium agent;uninfected MSC control:uninfected MSC+Calcium agent;Shenzhen Ruipuxun Academy for Stem Cell & Regenerative MedicineNULLRecruiting1865BothPTH naked plasmid-1:50;PTH naked plasmid-2:50;PTH naked plasmid-3:50;PTH-rhMSC-1:50;PTH-rhMSC-2:50;PTH-rhMSC-3:50;Calcium agent therapy control:50;pcDNA3.1 control:50;uninfected MSC control:50;Phase 1-2China
2NCT03425747
(ClinicalTrials.gov)
October 15, 201927/1/2018Efficacy of Calcium Citrate Versus Calcium Carbonate for the Management of Chronic HypoparathyroidismCALCIUM CITRATE vs CALCIUM CARBONATE FOR THE MANAGEMENT OF CHRONIC HYPOPARATHYROIDISMChronic HypoparathyroidismDrug: Calcium Carbonate;Drug: Calcium CitrateCampus Bio-Medico UniversityNULLCompleted18 Years75 YearsAll26Phase 4Italy
3NCT04126941
(ClinicalTrials.gov)
June 1, 201911/10/2019Monocentric Study on the Use of Teriparatide in Children With hypoparathyroïdismBi-daily Injection of Subcutaneous Teriparatide in Children With Hypoparathyroidism: Single-center ExperienceHypoparathyroidismOther: Serum calcium concentrations resultsHospices Civils de LyonNULLRecruiting2 Years18 YearsAll9France
4ChiCTR1900022194
2019-04-022019-03-30A prospective randomized controlled trial of different calcium supplementation regimens on the recovery of parathyroid function after thyroid surgeryA prospective randomized controlled trial of different calcium supplementation regimens on the recovery of parathyroid function after thyroid surgery HypoparathyroidismProphylactic group:Prophylactic calcium and vitamin D supplementation;treatment group:calcium and vitamin Dsupplementation is appropriate for hypocalcemia symptomatic patients;West China Hospital, Sichuan UniversityNULLRecruiting1875BothProphylactic group:150;treatment group:150;N/AChina
5NCT03249012
(ClinicalTrials.gov)
September 1, 20179/8/2017Quality of Life Related to Different Treatment Protocols for Post-thyroidectomy HypoparathyroidismComparing the Quality of Life Associated With Empiric Calcium Repletion and Parathormone (PTH) Based Calcium Repletion for Post Thyroidectomy HypoparathyroidismHypoparathyroidism Postprocedural;Quality of LifeOther: Empiric use of Calcium Carbonate and Calcitriol;Other: PTH based Calcium Carbonate and Calcitriol repletionCHU de Quebec-Universite LavalNULLRecruiting18 YearsN/AAll120N/ACanada
6NCT04146259
(ClinicalTrials.gov)
January 1, 201729/10/2019Changes in Circulating Sclerostin Levels During Acute Postsurgical HypoparathyroidismChanges in Circulating Sclerostin Levels During Acute Postsurgical HypoparathyroidismHypoparathyroidism PostproceduralDrug: calcium carbonate and alphacalcidolUniversity of AthensNULLCompleted19 YearsN/AFemale109Greece
7NCT01815021
(ClinicalTrials.gov)
April 20137/3/2013A Study Comparing Amorphous Calcium Carbonate (ACC) Versus Crystalline Calcium CCS) in Hypoparathyroidism PatientsA Randomized, Two Phase, Adaptive Then Crossover Open-label, Study Comparing Amorphous Calcium Carbonate (ACC) Supplement Versus Commercially Available Crystalline Calcium Supplements (CCS) in the Management of Primary Hypoparathyroidism.HypoparathyroidismDietary Supplement: amorphous calcium carbonate;Dietary Supplement: crystalline calcium supplementsAmorphical Ltd.NULLCompleted18 Years80 YearsBoth10Phase 1/Phase 2Israel
8JPRN-UMIN000002155
2009/09/0106/07/2009Effects of falecalcitoriol on post-operative hypoparathyroidism after thyroidectomy Postoperative hypoparathyroidismIn the first day after operation, we start administration of falecalcitriol at a dosage of 0.6ug once a day, when below the lower limit of serum calcium. If serum calcium level do not reach normal range, we escalete to 0.9ug/day.Oral calcium lactate is administered 3g/day in all enrolled patients.The dose is reduced when serum calcium and intact PTH level are maintained within normal range. If subjective symptoms such as tetany are worsen up, we start administration of calcium via DIV.kawasaki medicak schoolNULLComplete: follow-up completeNot applicableNot applicableMale and Female30Phase 3Japan
9NCT00824226
(ClinicalTrials.gov)
January 200915/1/2009Magnesium Treatment in HypoparathyroidismEffect of Magnesium Treatment on Plasma Calcium in Hypoparathyroid PatientsHypoparathyroidismDietary Supplement: magnesiumUniversity of TartuNULLCompleted18 YearsN/ABoth10N/AEstonia
10JPRN-UMIN000000475
2006/07/0101/09/2006Therapeutic strategy of relative hypoparathyroidism in hemodialysis patients using sevelamer hydrochloride, with special reference to vitamin D administration Relative hypoparathyoidism in maintenance hemodialysis patientsReplacement of calcium carbonate with sevelamer hydrochloride as phosphate binderHokusetsu ROD Study GroupNULLComplete: follow-up complete20years-oldNot applicableMale and Female40Not applicableJapan
11NCT00581828
(ClinicalTrials.gov)
January 200519/12/2007Does Treatment of Hypovitaminosis D Increase Calcium Absorption?Does Treatment of Hypovitaminosis D Increase Calcium Absorption?Osteoporosis;Osteopenia;Vitamin D Deficiency;Hypoparathyroidism;Hypercalciuria;HypercalcemiaDrug: Vitamin DUniversity of Wisconsin, MadisonNULLCompletedN/AN/AFemale19Phase 4United States
12NCT00004361
(ClinicalTrials.gov)
July 199518/10/1999Study of the Relationship Between Calcium Levels and Intact Parathyroid Hormone (iPTH) in Adults With Repaired or Palliated Conotruncal Cardiac DefectsHypoparathyroidism;Tetralogy of Fallot;Pulmonary Valve Stenosis;Conotruncal Cardiac Defects;Heart Defects, Congenital;Pulmonary AtresiaDrug: calcium gluconate;Drug: sodium citrateNational Center for Research Resources (NCRR)Ann & Robert H Lurie Children's Hospital of ChicagoCompleted18 YearsN/ABoth150N/ANULL
13NCT00001304
(ClinicalTrials.gov)
October 19913/11/1999Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34HypoparathyroidismDrug: Synthetic Human Parathyroid Hormone 1-34;Drug: Calcitriol & CalciumEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NULLCompleted17 Years69 YearsAll27Phase 2United States

256. 筋型糖原病


臨床試験数 : 180 薬物数 : 153 - (DrugBank : 30) / 標的遺伝子数 : 31 - 標的パスウェイ数 : 134
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05272969
(ClinicalTrials.gov)
March 31, 202228/1/2022Pompe & Pain - Study to Assess Nociceptive Pain in Adult Patients With Pompe DiseasePompe & Pain - Observational Study to Assess Musculoskeletal Pain in Late-onset Pompe Disease (LOPD)Pompe Disease (Late-onset);Inclusion Body Myositis;Spinal Muscular Atrophy Type 3;FSHDDiagnostic Test: Beck depression inventory fast screen (Questionnaire);Diagnostic Test: Brief Pain Inventory (BPI) (Questionnaire);Diagnostic Test: German Pain Inventory (Questionnaire);Diagnostic Test: Fatigue Severity and Disability Scale (FSS) (Questionnaire);Diagnostic Test: Rotterdam Handicap Scale (RHS) (Questionnaire);Diagnostic Test: R-PAct (Questionnaire);Diagnostic Test: Quick Motor Function Test;Diagnostic Test: Handheld Dynamometry (HHD);Diagnostic Test: Six-minute walk test (6MWT);Diagnostic Test: Pressure pain threshold;Diagnostic Test: Muscle ultrasound;Diagnostic Test: Vital signs;Diagnostic Test: Borg Scale;Diagnostic Test: Laboratory assessment: Creatine kinase;Diagnostic Test: Laboratory assessment: Vitamin D Level;Diagnostic Test: Laboratory assessment: calcium;Diagnostic Test: Laboratory assessment: magnesium;Diagnostic Test: Laboratory assessment: phosphate;Genetic: Genetic test: ACE polymorphism;Genetic: Genetic test: ACTN3 polymorphism;Genetic: Blood draw for optional genetic exome sequencingLMU KlinikumNULLNot yet recruiting18 YearsN/AAll95Germany

265. 脂肪萎縮症


臨床試験数 : 116 薬物数 : 170 - (DrugBank : 61) / 標的遺伝子数 : 26 - 標的パスウェイ数 : 97
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00017758
(ClinicalTrials.gov)
June 200111/6/2001The Effect of Efavirenz and Nelfinavir on the Blood Levels of Certain Lipid-Lowering DrugsThe Effect of Efavirenz and Nelfinavir on the Pharmacokinetics of Hydroxymethylglutaryl Coenzyme A Reductase InhibitorsHIV Infections;HIV Seronegativity;LipodystrophyDrug: Pravastatin sodium;Drug: Simvastatin;Drug: Atorvastatin calcium;Drug: Nelfinavir mesylate;Drug: EfavirenzNational Institute of Allergy and Infectious Diseases (NIAID)NULLCompleted18 Years60 YearsBoth56Phase 1United States

274. 骨形成不全症


臨床試験数 : 87 薬物数 : 103 - (DrugBank : 20) / 標的遺伝子数 : 14 - 標的パスウェイ数 : 76
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04545554
(ClinicalTrials.gov)
January 21, 20214/9/2020Study to Evaluate Romosozumab in Children and Adolescents With Osteogenesis ImperfectaAn Open-label, Ascending Multiple-dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Romosozumab in Children and Adolescents With Osteogenesis ImperfectaOsteogenesis ImperfectaDrug: Romosozumab;Dietary Supplement: Calcium;Dietary Supplement: Vitamin DAmgenNULLRecruiting5 Years17 YearsAll16Phase 1United States;Germany;Greece;Hungary;Italy;Spain;Turkey
2EUCTR2017-004972-74-IT
(EUCTR)
21/10/202021/01/2021An Open-label, Ascending Multiple dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Romosozumab in Children and Adolescents with Osteogenesis ImperfectaAn Open-label, Ascending Multiple-dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Romosozumab in Children and Adolescents With Osteogenesis Imperfecta - NA Osteogenesis imperfecta (OI) is a group of genetic skeletal disorders characterized by increased bone fragility, low bone mass, and increased bone turnover contributing to osteoporosis, fractures, and other conditions. OI is the most common form of primary osteoporosis in children with an estimated incidence of 1 per 25,000 live births.
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]
Trade Name: Evenity 105mg
Product Name: Romosozumab
Product Code: [AMG 785]
INN or Proposed INN: ROMOSOZUMAB
Trade Name: CALCIUM D3 SANDOZ - 1000 MG + 880 U.I. COMPRESSE EFFERVESCENTI 30 COMPRESSE DIVISIBILI
Product Name: Calcium D3
Product Code: [vitamina D e calcio]
INN or Proposed INN: CALCIO CARBONATO/COLECALCIFEROLO
AMGEN INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
24Phase 1France;Hungary;Greece;Spain;Turkey;Germany;Italy

298. 遺伝性膵炎


臨床試験数 : 98 薬物数 : 180 - (DrugBank : 57) / 標的遺伝子数 : 53 - 標的パスウェイ数 : 142
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01141998
(ClinicalTrials.gov)
December 200910/6/2010Vitamin D Substitution for Patients With Chronic Pancreatitis and MalabsorptionVitamin D Substitution for Patients With Chronic Pancreatitis and MalabsorptionChronic Pancreatitis;Malabsorption SyndromesDrug: Calcium, Dietary;Drug: Cholecalciferol;Radiation: UVB;Radiation: UV-filtered light.Hvidovre University HospitalNULLCompleted18 YearsN/ABoth27N/ADenmark
2NCT00156403
(ClinicalTrials.gov)
August 20058/9/2005A Pilot Study of Use of Calcium Channel Blocker to Decrease Inflammation and Pain in Hereditary PancreatitisHereditary Pancreatitis Amlodipine Trial(H-PAT): A Pilot StudyPancreatitisDrug: amlodipine (drug)University of PittsburghNational Center for Research Resources (NCRR)Completed6 YearsN/ABoth8Phase 1/Phase 2United States

299. 嚢胞性線維症


臨床試験数 : 1,696 薬物数 : 1,644 - (DrugBank : 272) / 標的遺伝子数 : 96 - 標的パスウェイ数 : 170
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2014-002387-32-GB
(EUCTR)
05/08/201427/06/2014Trial of Rosuvastatin for the Prevention of Kidney Toxicity caused by Tobramycin in Children with Cystic FibrosisPhase IIa, Randomised, Controlled, Open-Label Trial of Rosuvastatin for the Prevention of Aminoglycoside-Induced Kidney Toxicity in Children with Cystic Fibrosis - PROteKT Aminoglycoside-induced nephrotoxicity
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 18.0;Classification code 10069022;Term: Kidney injury molecule-1;System Organ Class: 10022891 - Investigations
MedDRA version: 18.0;Level: LLT;Classification code 10067571;Term: Nephrotoxicity;System Organ Class: 100000004857;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
Trade Name: Crestor
Product Name: Crestor
INN or Proposed INN: Rosuvastatin calcium
University of LiverpoolNULLNot RecruitingFemale: yes
Male: yes
50Phase 2United Kingdom
2NCT00004489
(ClinicalTrials.gov)
October 199818/10/1999Randomized Study of Alendronate in Adult Patients With Cystic Fibrosis Related OsteoporosisOsteoporosis;Cystic FibrosisDrug: alendronate sodium;Drug: calcium carbonate;Drug: cholecalciferolUniversity of North CarolinaNULLCompleted18 Years45 YearsBoth60N/AUnited States