A Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases
A study for pediatric patients with mild to moderate Ulcerative Colitis using study drug MMX Mesalamine/Mesalazine
Sponsor: Shire Development
Enrolling: Male and Female Patients
IRB Number: AAAP3004
U.S. Govt. ID: NCT02093663
Contact: Elena Reynoso: 000-000-0000 / er2564@cumc.columbia.edu
Additional Study Information: This study is evaluating an investigational medication to see if it is safe and if it works well in children andadolescents who have mild to moderate ulcerative colitis (UC) or are in remission. Ulcerative colitis (UC) is a chronic disease of the last section of the intestine, which is also known as the colon. If you have UC, the lining of your colon becomes inflamed and forms ulcers. UC often causes pain, bleeding, and loose bowel movements. UC is different from Crohns disease because UC only affects the lining of the colon. Crohns disease can affect any part of the gastrointestinal tract. UC is also different from irritable bowel syndrome (IBS). IBS does not cause inflammation of the intestinal tract. The goal of the study is to learn whether an investigational medication is safe and if it works well in children and adolescents aged 5 to 17 who have mild to moderate ulcerative colitis (UC) or are in remission. The investigational medication is already approved in multiple countries to treat UC in adults. Because it has not been approved for children and adolescents, it is considered investigational in this study.
This study is closed
Investigator
Ali Mencin, MD
Do You Qualify?
Does your child suffer from Ulcerative Colitis? Yes No
Does you child have Crohn's disease? Yes No
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You may be eligible for this study

Place Holder




For more information, please contact:
Elena Reynoso
er2564@cumc.columbia.edu
000-000-0000