Mesalamine for Ulcerative Colitis

Recruiting in Palo Alto (17 mi)

+9 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AbbVie

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing mesalamine capsules to see if they are safe and effective for children with Ulcerative Colitis. The medication helps reduce inflammation in the colon. About 80 children will take the capsules regularly for several months, and their health will be monitored through regular check-ups and tests. Mesalamine has been shown to be effective in maintaining remission in ulcerative colitis and is well-tolerated.

Eligibility Criteria

This trial is for children aged 5 to 17 with Ulcerative Colitis (UC) who have been in remission for at least 30 days and are on a stable dose of mesalamine or equivalent. They must not have significant abnormal results in physical exams, medical history, ECG, blood tests, or urinalysis.

Inclusion Criteria

I have Ulcerative Colitis in remission for 30+ days and am on a stable dose of mesalamine.

Exclusion Criteria

Abnormal and clinically significant results according to the investigator or designee, on physical examination, medical history, electrocardiogram (ECG), hematology, clinical chemistry, or urinalysis.

Treatment Details

Interventions

Mesalamine (Aminosalicylate)
Placebo (Drug)

Trial OverviewThe study is testing the safety and effectiveness of mesalamine capsules compared to a placebo in treating UC in kids. Participants will be randomly assigned to one of two groups and take the treatment twice daily for 26 weeks with follow-up.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Mesalamine Dose BExperimental Treatment2 Interventions

Participants will receive mesalamine Dose B twice daily for 26 weeks.

Group II: Mesalamine Dose AExperimental Treatment1 Intervention

Participants will receive mesalamine Dose A twice daily for 26 weeks.