97. Ulcerative colitis Clinical trials / Disease details


Clinical trials : 2,527 Drugs : 1,465 - (DrugBank : 259) / Drug target genes : 144 - Drug target pathways : 202

  
2 trials found
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1EUCTR2004-000734-36-CZ
(EUCTR)
13/07/200508/10/2004A phase III, randomized, multi-center, open-label, 12 to 14 months extension study to evaluate the safety and tolerability of SPD476 (mesalazine) give once daily vs. twice daily for the maintenance of ulcerative colitis in remission.A phase III, randomized, multi-center, open-label, 12 to 14 months extension study to evaluate the safety and tolerability of SPD476 (mesalazine) give once daily vs. twice daily for the maintenance of ulcerative colitis in remission. Subject not in remission of Ulcerative Colitis (UC-DAI score of >1) at the End of Study/Early Withdrawal Visit of Study 301 or 302.Subject in remission of UC (UC-DAI<1 with a score of 0 for rectal bleeding and stool frequency, and at least a 1 point reduction in the sigmoidocsopy score from Study 301 or 302 baseline) at the End of Study Visit of Study 301 or 302, or at the end of the Acute Phase of this studyProduct Name: Mesalazine
Product Code: SPD476
INN or Proposed INN: Mesalazinum
Other descriptive name: 5-amino salicylic acid (5-ASA)
Shire Pharmaceutical Development Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
125Phase 3Czech Republic
2EUCTR2004-000733-12-CZ
(EUCTR)
14/07/200401/07/2004A phase III, randomized, multi-center, double-blind, parallel-group, placebo controlled study to evaluate the safety and efficacy of SPD476 (mesalazine) given twice daily (2.4g/day) versus SPD476 given as a single dose (4.8g/day) in subject with acute mild to moderate ulcerative colitis.A phase III, randomized, multi-center, double-blind, parallel-group, placebo controlled study to evaluate the safety and efficacy of SPD476 (mesalazine) given twice daily (2.4g/day) versus SPD476 given as a single dose (4.8g/day) in subject with acute mild to moderate ulcerative colitis. Subjects who have newly diagnosed or have a diagnosis of relapsing (relapses1 and a Physician Global Assessment of <2). The original diagnosis of UC must be established by sigmoidoscopy, colonoscopy, or barium enema and have compatible histology.Product Name: Mesalazine
Product Code: SPD476
INN or Proposed INN: Mesalazinum
Other descriptive name: 5-amino salicylic acid (5-ASA)
Shire Pharmaceutical Development IncNULLNot RecruitingFemale: yes
Male: yes
255Phase 3Czech Republic