MMX Mesalamine/Mesalazine in Pediatrics With Mild to Moderate UC

To assess clinical response to MMX mesalamine/mesalazine between a low and high dose in children and adolescents aged 5-17 years with mild to moderate Ulcerative Colitis (UC) or who are in remission.

November 22, 2017

  • Clinical Trial Information

    Trial Contact: Parrimon, Yozandra; Tilme, Linda

    Trial Phone: 321.841.1361 ; 321.843.5278

  • IRB No: 13.173.11

    Protocol Abbrev: SHIRE SPD476-319

    Principal Investigator: Jeffrey A. Bornstein, MD

    Sub Investigators: FigueroaColon, Reinaldo MD; Horvath, Karoly MD; Mehta, Devendra MD; Safder, Shaista MD

    Phase: Drug: Phase III

    Age Group: Pediatric

    Secondary Protocol No: SPD476-319

    Treatment: MMX Mesalamine/Mesalazine

    Applicable Disease Sites: GI

    Therapies Involved: Interventional drug study

    ClinicalTrials.gov ID: NCT02093663

  • Objective

    To assess clinical response to MMX mesalamine/mesalazine between a low and high dose in children and adolescents aged 5-17 years with mild to moderate Ulcerative Colitis (UC) or who are in remission

  • Key Eligibility

    To assess clinical response to MMX mesalamine/mesalazine between a low and high dose in children and adolescents aged 5-17 years with mild to moderate Ulcerative Colitis (UC) or who are in remission.