ImproveCareNow Interventional_Research


A Randomized, Double-Blind Study to Assess the Safety and Efficacy of Mesalamine Delayed-Release Capsules in Children Aged 5 to 17 Years for the Maintenance of Remission of Ulcerative Colitis

A:

Purpose: The purpose of this study is to determine if ulcerative colitis pediatric patients can maintain remission on a 1.6 mg vs. 2.4 mg weight-based dosing of mesalamine DR (Delzicol).

Specific Aims:

Using adult studies as a guide, we aim to compare two weight-based, parallel arms of 2.4 mg vs 1.6 mg in maintaining UC remission over 26 weeks using the modified Mayo Score and other Mayo score derivatives.  Pediatric patients will be aged 5-17 and must have been on a stable dose of mesalamine or 5 ASA equivalent for 30 days prior to enrollment and must be in remission for 30 days.  Dosing choices are taken from adult maintenance mesalamine dosing.

Study Period: May 2022-March 2024

Contact: Charlotte Glenn, MD - AbbVie


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