97. 潰瘍性大腸炎
[臨床試験数:2,269,薬物数:1,331(DrugBank:241),標的遺伝子数:114,標的パスウェイ数:181

Searched query = "Ulcerative colitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
14 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-003349-41-DE
(EUCTR)
30/10/201919/12/2018Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitisA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis Active ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ST-0529
Product Code: FP-CYA-050
INN or Proposed INN: CICLOSPORIN
Other descriptive name: cyclosporine
Product Name: ST-0529
Product Code: FP-CYA-053
INN or Proposed INN: CICLOSPORIN
Other descriptive name: cyclosporine
Sublimity Therapeutics (Hold Co) Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
280Phase 2Belarus;Serbia;United States;Ukraine;Israel;Russian Federation;United Kingdom;France;Hungary;Canada;Poland;Bulgaria;Germany
2EUCTR2018-003349-41-BG
(EUCTR)
29/05/201927/02/2019Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitisA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis Active ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ST-0529
Product Code: FP-CYA-050
INN or Proposed INN: CICLOSPORIN
Other descriptive name: cyclosporine
Product Name: ST-0529
Product Code: FP-CYA-053
INN or Proposed INN: CICLOSPORIN
Other descriptive name: cyclosporine
Sublimity Therapeutics (Hold Co) Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
280Phase 2Belarus;Serbia;United States;Ukraine;Israel;Russian Federation;United Kingdom;France;Hungary;Canada;Poland;Bulgaria;Germany
3EUCTR2018-003349-41-GB
(EUCTR)
28/03/201921/12/2018Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitisA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis Active ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ST-0529
Product Code: FP-CYA-050
INN or Proposed INN: CICLOSPORIN
Other descriptive name: cyclosporine
Sublimity Therapeutics (Hold Co) Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
380Phase 2Belarus;Serbia;United States;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Canada;Poland;Romania;Bulgaria;Germany
4EUCTR2018-003349-41-PL
(EUCTR)
27/02/201915/01/2019Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitisA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis Active ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ST-0529
Product Code: FP-CYA-050
INN or Proposed INN: CICLOSPORIN
Other descriptive name: cyclosporine
Product Name: ST-0529
Product Code: FP-CYA-053
INN or Proposed INN: CICLOSPORIN
Other descriptive name: cyclosporine
Sublimity Therapeutics (Hold Co) Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
280Phase 2Belarus;Serbia;United States;Ukraine;Israel;Russian Federation;United Kingdom;France;Hungary;Canada;Poland;Bulgaria;Germany
5JPRN-UMIN000010776
2013/06/0101/06/2013An open label randomized controlled trial of tacrolimus versus cyclosporine treatment for severe ulcerative colitis Ulcerative colitistacrolimus (Prograf)
cyclosporine (Sandimmune)
Chiba University HospitalNULLRecruiting16years-old65years-oldMale and Female40Not selectedJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2008-003169-19-GB
(EUCTR)
04/03/201017/09/2009A Randomized, Double-blind, Placebo-controlled Study of a Controlled Release Minicapusle Formulation of Ciclosporin (CyCol™) in the Treatment of Ulcerative ColitisA Randomized, Double-blind, Placebo-controlled Study of a Controlled Release Minicapusle Formulation of Ciclosporin (CyCol™) in the Treatment of Ulcerative Colitis Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Sigmoid Pharma LtdNULLNot Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noIreland;United Kingdom
7NCT01033305
(ClinicalTrials.gov)
March 201015/12/2009Oral Ciclosporin for Colonic Release in Ulcerative Colitis (CyCol™)A Phase II, Randomized, Double-blind, Placebo-controlled Study of a Controlled Release Minicapsule Formulation of Ciclosporin (CyCol™) in the Treatment of Mild to Moderate Ulcerative ColitisMild to Moderate Ulcerative ColitisDrug: CyCol™;Drug: PlaceboSigmoid PharmaNULLCompleted18 YearsN/ABoth118Phase 2Ireland;United Kingdom
8EUCTR2008-003169-19-IE
(EUCTR)
09/11/200905/06/2008A Randomized, Double-blind, Placebo-controlled Study of a Controlled Release Minicapusle Formulation of Ciclosporin (CyCol™) in the Treatment of Ulcerative ColitisA Randomized, Double-blind, Placebo-controlled Study of a Controlled Release Minicapusle Formulation of Ciclosporin (CyCol™) in the Treatment of Ulcerative Colitis Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Product Name: CyCol
INN or Proposed INN: ciclosporin
Other descriptive name: cyclosporine (USAN)
Product Name: CyCol
INN or Proposed INN: ciclosporin
Other descriptive name: cyclosporine (USAN)
Sigmoid Pharma LtdNULLNot RecruitingFemale: yes
Male: yes
0United Kingdom;Ireland
9EUCTR2008-001968-36-GB
(EUCTR)
27/08/200815/07/2008Comparison of infliximab and ciclosporin in steroid resistant ulcerative colitis: a Trial - CONSTRUCTComparison of infliximab and ciclosporin in steroid resistant ulcerative colitis: a Trial - CONSTRUCT Acute severe steroid resistant ulcerative colitis
MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders
Swansea UniversityNULLNot Recruiting Female: yes
Male: yes
250 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited Kingdom
10EUCTR2006-005299-42-BE
(EUCTR)
20/05/200807/03/2008A randomized, multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis (CYSIF Study) - CYSIFA randomized, multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis (CYSIF Study) - CYSIF - Diagnosis of UC according to Lennard-Jones criteria - Endoscopically demonstrated colorectal lesions localized above the anal margin and extending at least up to 15cm proximally.- Severe acute flare of UC with a Lichtiger Index score > 10.- Refractoriness to high dose intravenous steroid therapy (= 0.8 mg/kg/d of methylprednisolone or equivalent) given for at least 5 days.
MedDRA version: 9.1;Level: LLT;Classification code 10045282;Term: UC
Trade Name: REMICADE
INN or Proposed INN: INFLIXIMAB
INN or Proposed INN: CICLOSPORIN
Other descriptive name: SANDINUM
INN or Proposed INN: CICLOSPORIN
Other descriptive name: NEORAL
Trade Name: CYCLOSPORIN
Trade Name: CYCLOSPORIN
GETAIDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Finland;Belgium;France;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2006-005299-42-ES
(EUCTR)
19/05/200803/03/2008Estudio multicéntrico abierto randomizado que compara ciclosporina e infliximab para el tratamiento de la colitis ulcerosa grave corticorrefractaria.A randomized multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis - CYSIFEstudio multicéntrico abierto randomizado que compara ciclosporina e infliximab para el tratamiento de la colitis ulcerosa grave corticorrefractaria.A randomized multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis - CYSIF Brote grave de colitis ulcerosa (Severe flare of ulcerative colitis)Trade Name: Sandimmum
Product Name: ciclosporina
Trade Name: Remicade
Product Name: infliximab
GETECCU (Grupo Español para el estudio de la enfermedad de Crohn y la colitis ulcerosa)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Finland;Belgium;France;Spain
12EUCTR2006-005299-42-FI
(EUCTR)
25/02/200827/12/2007A randomized, multicentre, open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitisSatunnaistettu, avoin, vertaileva monikeskustutkimus siklosporiinista ja infliximabista kortikosteroidille reagoimattoman vaikean haavaisen paksusuolitulehduksen hoidossa. - CYSIF STUDYA randomized, multicentre, open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitisSatunnaistettu, avoin, vertaileva monikeskustutkimus siklosporiinista ja infliximabista kortikosteroidille reagoimattoman vaikean haavaisen paksusuolitulehduksen hoidossa. - CYSIF STUDY Tutkimuksessa verrataan kortikosteroidihoidolle reagoimattoman haavaisen paksusuolitulehduksen hoitoa käyttämällä suonensisäistä siklosporiinihoitoa 2 mg/kg/vrk 7 vrk:n ajan ja siklosporiini (Sandimmun Neoral) 4 mg/kg/vrk suun kautta tämän jälkeen 3 kk:n ajan verrattuna infliximabi (Remicade) 5 mg/kg iv viikoilla 0, 2 ja 6.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Sandimmun 50 mg/ml, infuusiokonsentraatti
INN or Proposed INN: CICLOSPORIN
Trade Name: Sandimmun Neoral
INN or Proposed INN: CICLOSPORIN
Trade Name: Remicade 100 mg infuusiokuiva-aine, konsentraattiliuosta varten
INN or Proposed INN: INFLIXIMAB
Groupe d'Etude Thérapeutique des Affections Inflammatoires Digestives (G.E.T.A.I.D.)NULLNot RecruitingFemale: yes
Male: yes
100France;Finland;Belgium;Spain
13NCT00542152
(ClinicalTrials.gov)
June 20078/10/2007Study Comparing Cyclosporine With Infliximab in Steroid-refractory Severe Attacks of Ulcerative ColitisA Randomized, Multicenter Open Label Study Comparing Cyclosporine With Infliximab in Steroid-refractory Severe Attacks of Ulcerative ColitisUlcerative Colitis;Steroid RefractoryDrug: CYCLOSPORINE VS INFLIXIMABGroupe d'Etude Therapeutique des Affections Inflammatoires DigestivesNULLCompleted18 YearsN/ABoth115Phase 4Belgium;Finland;France;Italy;Spain
14EUCTR2006-005299-42-FR
(EUCTR)
16/05/200706/03/2007A randomized, multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis (CYSIF Study) - CYSIFA randomized, multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis (CYSIF Study) - CYSIF - Diagnosis of UC according to Lennard-Jones criteria - Endoscopically demonstrated colorectal lesions localized above the anal margin and extending at least up to 15cm proximally.- Severe acute flare of UC with a Lichtiger Index score > 10.- Refractoriness to high dose intravenous steroid therapy (= 0.8 mg/kg/d of methylprednisolone or equivalent) given for at least 5 days.
MedDRA version: 9.1;Level: LLT;Classification code 10045282;Term: UC
Trade Name: REMICADE
INN or Proposed INN: INFLIXIMAB
INN or Proposed INN: CICLOSPORIN
Other descriptive name: SANDINUM
INN or Proposed INN: CICLOSPORIN
Other descriptive name: NEORAL
Trade Name: CYCLOSPORIN
Trade Name: CYCLOSPORIN
GETAIDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Finland;Belgium;France;Spain