| October 23, 2007 |
| May 5, 2009 |
| December 2003 |
| |
| Percentage of subjects in remission (UC-DAI score <=1, with scores of 0 for rectal bleeding and stool frequency and a sigmoidoscopy score reduction of 1 point or more from baseline) [ Time Frame: 8 weeks ] |
| Same as current |
| Complete list of historical versions of study NCT00548574 on ClinicalTrials.gov Archive Site |
- Clinical improvement as defined by a drop of => 3 points from baseline in the overall UC-DAI score [ Time Frame: 8 weeks ]
- Change from baseine in UC-DAI score, symptoms, sigmoidscopy score, and PGA [ Time Frame: 8 weeks ]
- Clinical remission defined as subjects who scored 0 for both the total stool frequency and the total rectal bleeding score [ Time Frame: 8 weeks ]
- Treatment failure defined as unchanged, worsened missing or imcomplete UC-DAI score [ Time Frame: 8 weeks ]
|
| Same as current |
| |
| 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 |
The primary objective of the study was to compare the percentage of subjects in remission after 8 weeks of treatment with SPD476, 2.4 g/day once daily vs placebo and SPD476 4.8 g/day once daily versus placebo |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Ulcerative Colitis |
- Drug: SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine
- Drug: Mesalazine
|
| |
| Kamm MA, Sandborn WJ, Gassull M, Schreiber S, Jackowski L, Butler T, Lyne A, Stephenson D, Palmen M, Joseph RE. Once-daily, high-concentration MMX mesalamine in active ulcerative colitis. Gastroenterology. 2007 Jan;132(1):66-75; quiz 432-3. Epub 2006 Oct 12. |
| |
| Completed |
| 343 |
| July 2005 |
|
Inclusion Criteria:
- newly diagnosed or relapsing mild to moderate UC (score of 4-10 (inclusive) on the UC-DAI scale, with a sigmoidoscopy score of => 1 and a PGA <=2) with compatible histology
- females eligible if post--menopausal, surgically sterile or if they had a negative urine pregnancy test at screening and were on adequate contraception
Exclusion Criteria:
- subjects with relapsing UC who were in relapse for > 6 weeks prior to baseline
- subjects who relapsed on maintenace therapy with doses of mesalazine => 2g/day
- subjects who had unsuccessfully treated their current relapse with steroids or a mesalazine dose of > 2g/day
- subjects with Crohn's disease, proctitis, bleeding disorders, active peptic ulcer disease, previous colonic surgery, or those at an immediate risk of toxic megacolon or a stool culture positive for enteric pathogens
- subjects who had used systemic or rectal steroids within the last 4 weeks, immunosuppressants wihtin the last 6 weeks or anti-inflammatory drugs on a repeat basis within 7 days prior to the baseline visit
- subjects with hypersensitivity to salicylates and subjects with moderate/severe renal impairment
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Belgium |
| |
| NCT00548574 |
|
| SPD476-302 |
| Shire Pharmaceutical Development |
|
| Principal Investigator: |
Professor Michael Kamm |
St Marks Hospital, London, UK |
|
|
| Shire Pharmaceutical Development |
| November 2007 |
