COLECALCIFEROL ( DrugBank: Colecalciferol )


4 diseases
告示番号疾患名(ページ内リンク)臨床試験数
13多発性硬化症/視神経脊髄炎15
46悪性関節リウマチ2
96クローン病2
228閉塞性細気管支炎1

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
1EUCTR2012-004602-97-ES
(EUCTR)
11/01/201312/11/2012?Vitamin D as add-on treatment for relapsing-remitting multiple sclerosis: an unicentric, randomized, double-blinded, placebo-controlled clinical trial??Vitamin D as add-on treatment for relapsing-remitting multiple sclerosis: an unicentric, randomized, double-blinded, placebo-controlled clinical trial? - VITADEM RELAPSING-REMITING MULTIPLE SCLEROSIS
MedDRA version: 14.1;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]
Trade Name: VITAMINA D3 KERN PHARMA SOLUCIÓN OLEOSA
INN or Proposed INN: COLECALCIFEROL
Other descriptive name: COLECALCIFEROL CONCENTRATE (OILY FORM)
Javier Olascoaga UrtazaNULLNot RecruitingFemale: yes
Male: yes
100Phase 2Spain
2EUCTR2010-020328-23-PT
(EUCTR)
06/01/201217/11/2011Supplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment.A three-arm, randomized, double-blind, placebo controlled, multicenter,phase II study to evaluate the efficacy of Vigantol® oil as add-ontherapy in subjects with Relapsing-Remitting Multiple Sclerosis receivingtreatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR Relapsing-Remitting Multiple Sclerosis
MedDRA version: 14.0;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]
Trade Name: Vigantol Oel
Product Name: Vigantol Oil
Product Code: 200106 or EMD 28162
INN or Proposed INN: COLECALCIFEROL
Other descriptive name: Cholecalciferol, Vitamin D3
Merck Serono SA - Geneva, an affiliate of Merck KGaA,NULLNot RecruitingFemale: yes
Male: yes
358Phase 2Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Hungary;Belgium;Denmark;Norway;Germany;Latvia;Netherlands
3EUCTR2010-020328-23-AT
(EUCTR)
23/11/201128/10/2011Supplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment.A three-arm, randomized, double-blind, placebo controlled, multicenter,phase II study to evaluate the efficacy of Vigantol® oil as add-ontherapy in subjects with Relapsing-Remitting Multiple Sclerosis receivingtreatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR Relapsing-Remitting Multiple Sclerosis
MedDRA version: 14.1;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]
Trade Name: Vigantol Oel
Product Name: Vigantol Oil
Product Code: 200106 or EMD 28162
INN or Proposed INN: COLECALCIFEROL
Other descriptive name: Cholecalciferol, Vitamin D3
Merck Serono SA - Geneva, an affiliate of Merck KGaA,NULLNot RecruitingFemale: yes
Male: yes
358Phase 2Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Hungary;Belgium;Denmark;Norway;Germany;Latvia;Netherlands
4EUCTR2011-002785-20-DE
(EUCTR)
19/09/201111/08/2011Efficacy of Vitamin D Supplementation in relapsing-remitting Multiple SclerosisEfficacy of Vitamin D Supplementation in relapsing-remitting Multiple Sclerosis - EVIDIMS Multiple Sclerosis and Clinical isolated Syndrome;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Vigantol® Öl 20.000 I.E./ml
Product Name: Vigantol® Öl 20.000 I.E./ml
Product Code: Vigantol® Öl 20.000 I.E./ml
INN or Proposed INN: COLECALCIFEROL
Trade Name: Dekristol®-Tablette 1 (400 IE)
Product Name: Dekristol® 400-Tabletten
Product Code: Dekristol® 400-Tabletten
INN or Proposed INN: COLECALCIFEROL
Other descriptive name: 25OH-Vitamin D
Charité - Universitätsmedizin BerlinNULLNot RecruitingFemale: yes
Male: yes
Phase 2Germany
5EUCTR2010-020328-23-LV
(EUCTR)
19/07/201116/05/2011Supplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment.A three-arm, randomized, double-blind, placebo controlled, multicenter,phase II study to evaluate the efficacy of Vigantol® oil as add-ontherapy in subjects with Relapsing-Remitting Multiple Sclerosis receivingtreatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR Relapsing-Remitting Multiple Sclerosis
MedDRA version: 16.0;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]
Trade Name: Vigantol Oel
Product Name: Vigantol Oil
Product Code: 200106 or EMD 28162
INN or Proposed INN: COLECALCIFEROL
Other descriptive name: Cholecalciferol, Vitamin D3
Merck SeronoNULLNot RecruitingFemale: yes
Male: yes
230Phase 2Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Belgium;Denmark;Latvia;Norway;Germany;Netherlands
6EUCTR2010-020328-23-EE
(EUCTR)
26/04/201121/03/2011Supplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment.A three-arm, randomized, double-blind, placebo controlled, multicenter, phase II study to evaluate the efficacy of Vigantol® oil as add-on therapy in subjects with Relapsing-Remitting Multiple Sclerosis receiving treatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR Relapsing-Remitting Multiple Sclerosis
MedDRA version: 14.1;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]
Trade Name: Vigantol Oel
Product Name: Vigantol Oil
Product Code: EMD 28162
INN or Proposed INN: COLECALCIFEROL
Other descriptive name: Cholecalciferol, Vitamin D3
Merck SeronoNULLNot RecruitingFemale: yes
Male: yes
230Phase 2Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Belgium;Denmark;Norway;Germany;Latvia;Netherlands
7EUCTR2010-023677-19-IT
(EUCTR)
23/03/201110/06/2011Bio-molecular effects of interferon-beta and d-vitamin association - VITAD-2010Bio-molecular effects of interferon-beta and d-vitamin association - VITAD-2010 PATIENT WITH RRMS AND SPMS
MedDRA version: 13.1;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive;System Organ Class: 10029205 - Nervous system disorders
Trade Name: BETAFERON*15CONFEZ 0,25MG/ML+
INN or Proposed INN: Interferon beta-1b
Trade Name: EXTAVIA*SC 15FL 250MCG/ML+15SI
INN or Proposed INN: Interferon beta-1b
Trade Name: DIBASE
INN or Proposed INN: Colecalciferol
AZIENDA OSPEDALIERA S. LUIGI GONZAGANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
8EUCTR2010-020328-23-IT
(EUCTR)
10/03/201107/02/2011A THREE-ARM, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, MULTICENTER, PHASE II STUDY TO EVALUATE THE EFFICACY OF VIGANTOL OIL AS ADD-ON THERAPY IN SUBJECTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS RECEIVING TREATMENT WITH REBIF (SOLAR) - SOLARA THREE-ARM, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, MULTICENTER, PHASE II STUDY TO EVALUATE THE EFFICACY OF VIGANTOL OIL AS ADD-ON THERAPY IN SUBJECTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS RECEIVING TREATMENT WITH REBIF (SOLAR) - SOLAR RELAPSING REMITTING MULTIPLE SCLEROSIS
MedDRA version: 9.1;Level: PT;Classification code 10063399
Trade Name: VIGANTOL OIL
INN or Proposed INN: Colecalciferol
MERCK SERONO SANULLNot RecruitingFemale: yes
Male: yes
358Phase 2Portugal;Estonia;Finland;Belgium;Lithuania;Austria;Denmark;Latvia;Germany;Netherlands;Italy
9EUCTR2010-020328-23-NL
(EUCTR)
06/01/201116/09/2010A three-arm, randomized, double-blind, placebo controlled, multicenter, phase II study to evaluate the efficacy of Vigantol® oil as add-on therapy in subjects with Relapsing-Remitting Multiple Sclerosis receiving treatment with Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment. - SOLARA three-arm, randomized, double-blind, placebo controlled, multicenter, phase II study to evaluate the efficacy of Vigantol® oil as add-on therapy in subjects with Relapsing-Remitting Multiple Sclerosis receiving treatment with Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR Relapsing-Remitting Multiple Sclerosis
MedDRA version: 12.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: Vigantol Oel
Product Name: Vigantol Oil
Product Code: EMD 28162
INN or Proposed INN: COLECALCIFEROL
Other descriptive name: Cholecalciferol, Vitamin D3
Merck Serono The Netherlands - a division of Merck B.V.NULLNot RecruitingFemale: yes
Male: yes
358Phase 2Portugal;Estonia;Finland;Belgium;Lithuania;Austria;Denmark;Latvia;Germany;Netherlands;Italy
10EUCTR2010-020328-23-DK
(EUCTR)
09/12/201008/11/2010Supplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment.A three-arm, randomized, double-blind, placebo controlled, multicenter,phase II study to evaluate the efficacy of Vigantol® oil as add-ontherapy in subjects with Relapsing-Remitting Multiple Sclerosis receivingtreatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR Relapsing-Remitting Multiple Sclerosis
MedDRA version: 14.1;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]
Trade Name: Vigantol Oel
Product Name: Vigantol Oil
Product Code: 200106 or EMD 28162
INN or Proposed INN: COLECALCIFEROL
Other descriptive name: Cholecalciferol, Vitamin D3
Merck SeronoNULLNot RecruitingFemale: yes
Male: yes
230Phase 2Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Belgium;Denmark;Norway;Germany;Latvia;Netherlands
11EUCTR2010-020328-23-FI
(EUCTR)
21/10/201027/08/2010Supplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment.A three-arm, randomized, double-blind, placebo controlled, multicenter,phase II study to evaluate the efficacy of Vigantol® oil as add-ontherapy in subjects with Relapsing-Remitting Multiple Sclerosis receivingtreatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR Relapsing-Remitting Multiple Sclerosis
MedDRA version: 14.1;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]
Trade Name: Vigantol Oel
Product Name: Vigantol Oil
Product Code: 200106 or EMD 28162
INN or Proposed INN: COLECALCIFEROL
Other descriptive name: Cholecalciferol, Vitamin D3
Merck SeronoNULLNot RecruitingFemale: yes
Male: yes
230Phase 2Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Belgium;Denmark;Norway;Germany;Latvia;Netherlands
12EUCTR2009-013695-46-FR
(EUCTR)
22/10/200907/09/2009ETUDE MULTICENTRIQUE, RANDOMISEE EN DOUBLE AVEUGLE VERSUS PLACEBO EVALUANT L’EFFICACITE D’UN TRAITEMENT ADDITIONNEL PAR CHOLECALCIFEROL (VITAMINE D3) CHEZ DES PATIENTS ATTEINTS DE SCLEROSE EN PLAQUES RECURRENTE (SEP-R) TRAITES PAR INTERFERON BETA 1A 44 µG 3 FOIS PAR SEMAINE PAR VOIE SOUS-CUTANEE - cholineETUDE MULTICENTRIQUE, RANDOMISEE EN DOUBLE AVEUGLE VERSUS PLACEBO EVALUANT L’EFFICACITE D’UN TRAITEMENT ADDITIONNEL PAR CHOLECALCIFEROL (VITAMINE D3) CHEZ DES PATIENTS ATTEINTS DE SCLEROSE EN PLAQUES RECURRENTE (SEP-R) TRAITES PAR INTERFERON BETA 1A 44 µG 3 FOIS PAR SEMAINE PAR VOIE SOUS-CUTANEE - choline Sclérose en plaques récurrente (SEP-R)
MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: UVEDOSE 100 000 UI, solution buvable en ampoule
Product Name: UVEDOSE 100 000 UI
INN or Proposed INN: COLECALCIFEROL
MERCK SERONO s.a.sNULLNot RecruitingFemale: yes
Male: yes
France
13NCT01432704
(ClinicalTrials.gov)
March 200816/8/2011Colecalciferol as an Add-on Treatment to Subcutaneously-Administered Interferon-beta-1b for Treatment of Multiple Sclerosis (MS)Phase IV Study of Colecalciferol as an Add-on Treatment to Subcutaneously Administered Interferon-beta-1b for Treatment of MSMultiple SclerosisDrug: colecalciferolUniversity of TurkuBayerCompleted18 Years50 YearsBoth70Phase 2/Phase 3NULL
14NCT01339676
(ClinicalTrials.gov)
March 200819/4/2011Colecalciferol as an Add-on Treatment to Interferon-beta-1b for Treatment of Multiple Sclerosis (MS)Colecalciferol as an Add-on Treatment to Subcutaneously Administered Interferon-beta-1b for Treatment of MSMultiple SclerosisDrug: Colecalciferol;Drug: Placebo capsulesUniversity of TurkuNULLActive, not recruiting18 Years55 YearsBoth70Phase 4Finland
15EUCTR2007-001958-99-FI
(EUCTR)
18/12/200707/12/2007Collecalciferol as an Add-on Treatment to Subcutaneously-Administred Interferon-beta-1b for Treatment MSCollecalciferol as an Add-on Treatment to Subcutaneously-Administred Interferon-beta-1b for Treatment MS Patients with relapsing remitting MS according to the revised Mc Donald's criteria who meet all criteria for inclusion and none criteria of exclusion.
MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: Dekristol 20000 IE
Product Name: Dekristol
INN or Proposed INN: INN COLECALCIFEROL
Product Name: Placebo Dekristol SGC 20000
Merja Soilu HäninenNULLNot RecruitingFemale: yes
Male: yes
Finland

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
1EUCTR2009-012615-18-FR
(EUCTR)
16/02/201105/11/2010Efficacy and safety of cholecalciferol on rheumatoid arthritis activity in patients with vitamin D deficiency - SCORPIONEfficacy and safety of cholecalciferol on rheumatoid arthritis activity in patients with vitamin D deficiency - SCORPION Rheumatoid arthritis (RA)
MedDRA version: 12.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions
Trade Name: UVEDOSE
INN or Proposed INN: COLECALCIFEROL
CHU de Clermont-FerrandNULLNot RecruitingFemale: yes
Male: yes
France
2EUCTR2009-015835-34-IT
(EUCTR)
09/04/201029/03/2010VITAMIN D EFFECT ON T LYMPHOCYTES AND OSTEOCLASTOGENESIS IN RHEUMAOID ARTHRITIS - NDVITAMIN D EFFECT ON T LYMPHOCYTES AND OSTEOCLASTOGENESIS IN RHEUMAOID ARTHRITIS - ND Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid
Trade Name: DIBASE*IM OS 2F 1ML 300000UI/M
INN or Proposed INN: Colecalciferol
AZIENDA OSPEDALIERA ORDINE MAURIZIANONULLNot RecruitingFemale: yes
Male: no
Phase 3Italy

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
1EUCTR2013-002838-20-NL
(EUCTR)
12/11/201306/09/2013The effect of Vitamin D to prevent post-operative relapse of Crohn's DiseaseThe effect of Vitamin D3 to prevent post-operative relapse of Crohn’s Disease: a placebo-controlled randomized trial (DETECT) - DETECT Crohn's Disease
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: InVita D3
INN or Proposed INN: Colecalciferol
Other descriptive name: CHOLECALCIFEROL CONCENTRATE
Academic Medical CenterNULLNot RecruitingFemale: yes
Male: yes
142Phase 3Belgium;Netherlands
2NCT00672763
(ClinicalTrials.gov)
May 20082/5/2008Adjuvant Vitamin D With Corticosteroids in Active Crohn's DiseaseThe Immunomodulatory Role of Vitamin D in Inflammatory Bowel Disease (The IBDVit Study): Double-Blind, Placebo-Controlled Trial of Adjuvant Vitamin D (Colecalciferol) With Corticosteroids in Active Crohn's DiseaseCrohn's DiseaseDrug: Colecalciferol D3 (Vigantol Oil);Drug: Medium chain triglyceridesImperial College LondonNULLWithdrawn18 YearsN/ABoth0Phase 4United Kingdom

228. 閉塞性細気管支炎


臨床試験数 : 96 薬物数 : 125 - (DrugBank : 34) / 標的遺伝子数 : 33 - 標的パスウェイ数 : 155
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2010-022027-30-BE
(EUCTR)
23/09/201002/09/2010A randomized placebo-controlled double blind study to prevent BOS - VIT001A randomized placebo-controlled double blind study to prevent BOS - VIT001 A study to prevent the occurence of chronic rejection after lung transplantation. Other points of investigation include lung function evolution, rate of survival, BAL cellularity, infection rate, rate of acute rejection and reflux
MedDRA version: 12.1;Level: LLT;Classification code 10029888;Term: Obliterative bronchiolitis
MedDRA version: 12.1;Classification code 10049202;Term: Bronchiolitis obliterans
MedDRA version: 12.1;Classification code 10068805;Term: Follicular bronchiolitis
MedDRA version: 12.1;Classification code 10019319;Term: Heart-lung transplant rejection
MedDRA version: 12.1;Classification code 10025127;Term: Lung transplant
MedDRA version: 12.1;Classification code 10050433;Term: Prophylaxis against lung transplant rejection
MedDRA version: 12.1;Classification code 10050437;Term: Prophylaxis against heart and lung transplant rejection
MedDRA version: 12.1;Classification code 10051604;Term: Lung transplant rejection
MedDRA version: 12.1;Classification code 10056409;Term: Heart and lung transplant
MedDRA version: 12.1;Classification code 10016547;Term: FEV
MedDRA version: 12.1;Classification code 10016549;Term: FEV 1 abnormal
MedDRA version: 12.1;Classification code 10016550;Term: FEV 1 decreased
MedDRA version: 12.1;Classification code 10016553;Term: FEV 1 low
Trade Name: D-Cure
Product Name: D-cure
INN or Proposed INN: COLECALCIFEROL
UZ GasthuisbergNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Belgium