المصدر: A Phase III, Randomized Multi-centre, Double-blind, Parallel Group, Active Comparator Study to Compare the Efficacy and Safety of SPD476 (Mesalazine)2.4g/Day Once Daily With Asacol 1.6g/Day Twice Daily in the Maintenance of Remission in Patients With Ulcerative Colitis

الوصول الحر: https://clinicaltrials.gov/ct2/show/NCT00151892Test

Other URLs: http://www.lialda.com/Professional/pdf/pi.pdfTest
http://www.fda.gov/opacom/7alerts.htmlTest

المصدر: Kamm MA, Lichtenstein GR, Sandborn WJ, Schreiber S, Lees K, Barrett K, Joseph R. Randomised trial of once- or twice-daily MMX mesalazine for maintenance of remission in ulcerative colitis. Gut. 2008 Jul;57(7):893-902. doi: 10.1136/gut.2007.138248. Epub 2008 Feb 13.
Kamm MA, Lichtenstein GR, Sandborn WJ, Schreiber S, Lees K, Barrett K, Joseph R. Effect of extended MMX mesalamine therapy for acute, mild-to-moderate ulcerative colitis. Inflamm Bowel Dis. 2009 Jan;15(1):1-8. doi: 10.1002/ibd.20580.
A Phase III, Randomized, Multi-center, Open-label, 12 to 14 Month Extension Study to Evaluate the Safety and Tolerability of SPD476 (Mesalazine) Given Once Daily vs. Twice Daily for the Maintenance of Ulcerative Colitis in Remission.

الوصول الحر: https://clinicaltrials.gov/ct2/show/NCT00151944Test

Other URLs: http://www.fda.gov/opacom/7alerts.htmlTest
http://www.lialda.com/Professional/pdf/pi.pdfTest

المصدر: Kane S, Katz S, Jamal MM, Safdi M, Dolin B, Solomon D, Palmen M, Barrett K. Strategies in maintenance for patients receiving long-term therapy (SIMPLE): a study of MMX mesalamine for the long-term maintenance of quiescent ulcerative colitis. Inflamm Bowel Dis. 2012 Jun;18(6):1026-33. doi: 10.1002/ibd.21841. Epub 2011 Aug 11.
A Phase IV, Multi-center, Open-label Study to Assess Clinical Recurrence Related to Compliance With Treatment With MMX Mesalamine 2.4g/Day Given Once Daily for the Maintenance of Quiescent Ulcerative Colitis (UC)

الوصول الحر: https://clinicaltrials.gov/ct2/show/NCT00446849Test

Other URLs: http://www.fda.gov/opacom/7alerts.htmlTest
http://www.lialda.com/Professional/pdf/pi.pdfTest

المصدر: Lichtenstein GR, Kamm MA, Boddu P, Gubergrits N, Lyne A, Butler T, Lees K, Joseph RE, Sandborn WJ. Effect of once- or twice-daily MMX mesalamine (SPD476) for the induction of remission of mild to moderately active ulcerative colitis. Clin Gastroenterol Hepatol. 2007 Jan;5(1):95-102. doi: 10.1016/j.cgh.2006.10.025.
A Phase III, Randomized, Multi-Centre, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) Versus SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative Colitis

الوصول الحر: https://clinicaltrials.gov/ct2/show/NCT00503243Test

Other URLs: http://www.lialda.com/Professional/pdf/pi.pdfTest
http://www.fda.gov/opacom/7alerts.htmlTest

المصدر: A Phase III, Randomised, Double-Blind, Dose-Response, Stratified, Placebo-Controlled Study Evaluating the Safety and Efficacy of SPD476 Versus Placebo Over 104 Weeks in the Prevention of Recurrence of Diverticulitis.

الوصول الحر: https://clinicaltrials.gov/ct2/show/NCT00545103Test

المصدر: D'Haens G, Hommes D, Engels L, Baert F, van der Waaij L, Connor P, Ramage J, Dewit O, Palmen M, Stephenson D, Joseph R. Once daily MMX mesalazine for the treatment of mild-to-moderate ulcerative colitis: a phase II, dose-ranging study. Aliment Pharmacol Ther. 2006 Oct 1;24(7):1087-97. doi: 10.1111/j.1365-2036.2006.03082.x.
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

الوصول الحر: https://clinicaltrials.gov/ct2/show/NCT00545389Test

Other URLs: http://www.lialda.comTest/
http://www.fda.gov/opacom/7alerts.htmlTest

المصدر: A Phase III, Randomised, Double-Blind, Dose-Response, Stratified, Placebo-Controlled Study Evaluating the Safety and Efficacy of SPD476 Versus Placebo Over 104 Weeks in the Prevention of Recurrence of Diverticulitis.

الوصول الحر: https://clinicaltrials.gov/ct2/show/NCT00545740Test

المصدر: 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. doi: 10.1053/j.gastro.2006.10.011. Epub 2006 Oct 12.
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

الوصول الحر: https://clinicaltrials.gov/ct2/show/NCT00548574Test

Other URLs: http://www.lialda.com/Professional/pdf/pi.pdfTest
http://www.fda.gov/opacom/7alerts.htmlTest

المصدر: A Phase 4, Open-label, Multicenter, Prospective Study to Evaluate the Effect of Remission Status on the Ability to Maintain or Achieve Clinical and Endoscopic Remission During a 12-Month, Long-term Maintenance Phase With 2.4g/Day MMX Mesalamine/Mesalazine Once Daily in Adult Subjects With Ulcerative Colitis

الوصول الحر: https://clinicaltrials.gov/ct2/show/NCT01124149Test

المصدر: A Phase 1, Multicenter, Open-label Study to Determine the Safety and Pharmacokinetics of MMX Mesalamine Following Administration in Children and Adolescents With Ulcerative Colitis

الوصول الحر: https://clinicaltrials.gov/ct2/show/NCT01130844Test