SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine ( DrugBank: Mesalazine )

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1 disease

ID	Disease name (Link within this page)	Number of trials
97	Ulcerative colitis	2

97. Ulcerative colitis

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

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT00548574 (ClinicalTrials.gov)	December 4, 2003	23/10/2007	Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to Asacol 0.8g Three Times Daily in Subjects With Acute, Mild to Moderate Ulcerative Colitis	A Phase III, Randomized, Multi-Centre, Double-blind, Double Dummy, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to ASACOL 0.8g Three Times Daily, in Subjects With Mild to Moderate Ulcerative Colitis	Ulcerative Colitis	Drug: SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine;Drug: Mesalazine	Shire	NULL	Completed	18 Years	N/A	All	343	Phase 3	Belgium
2	NCT00545389 (ClinicalTrials.gov)	February 10, 2003	16/10/2007	Phase II Dose-Ranging Study in Subjects With Mild to Moderate Ulcerative Colitis Treated With SPD476	A Phase II, Randomized, Multi-centre, Double-blind, Parallel-group, Dose-ranging, Exploratory Study in Subjects With Mild to Moderate Ulcerative Colitis Treated With SPD476 (Mesalazine) Once Daily	Colitis, Ulcerative	Drug: SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine	Shire	NULL	Completed	18 Years	N/A	All	38	Phase 2	Belgium