Spd476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine (DrugBank: Mesalazine)
1 disease| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 97 | Ulcerative colitis | 2 |
| 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 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 | Both | 343 | Phase 3 | Belgium |
| 2 | NCT00545389 (ClinicalTrials.gov) | February 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 | Both | 38 | Phase 2 | Belgium |