Ulcerative Colitis in Children and Adolescents
A Randomized, Double-blind, Parallel-group Study to Assess the Safety and Efficacy of Asacol® (1.2 to 4.8 g/day) Administered as 400 mg Delayed-release Tablets Given Every 12 Hours for 6 Weeks to Children and Adolescents with Mildly-to-Moderately Active Ulcerative Colitis
Protocol ID
Protocol Description
Ulcerative colitis (UC) is a disease of the colon. In this disease, there is inflammation and ulceration of the innermost lining of the colon. The experimental drug, mesalamine, affects the end section of the small intestine and the large intestine. This may lead to a reduction in the symptoms of UC. The most important purpose of this study is to provide information about the process by which mesalamine is absorbed, distributed, broken down and eliminated by the body. Another purpose of this study is to look at the safety and tolerability of mesalamine in the pediatric and adolescent population. Mesalamine is approved for treating UC in adults.
Eligibility Criteria
Children and adolescents with ulcerative colitis
Primary Investigator(s)
- Jeremiah J. Levine, MD