97. 潰瘍性大腸炎 Ulcerative colitis Clinical trials / Disease details


臨床試験数 : 2,630 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202

  
4 trials found
No.TrialIDDate_
enrollment
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1EUCTR2008-001968-36-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
Trade Name: Remicade
Trade Name: Sandimmun
Trade Name: Neoral Soft Gelatin Capsules
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
2EUCTR2006-005299-42-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
3EUCTR2006-005299-42-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
4EUCTR2006-005299-42-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