A Study to Assess Adverse Events and Change in Disease Condition of Mesalamine Capsules in Children Aged 5 to 17 Years With Ulcerative Colitis
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Phase
Phase 3
Status
Withdrawn
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
0actual
Sites
10
Countries
Puerto Rico, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Why the sponsor stopped it
strategic considerations
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-09-15 | estimated | When the study began enrolling |
| Primary completion | 2026-07-19 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-07-19 | estimated | The whole study's end, after follow-up |
| First posted | 2022-04-07 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-08-12 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Ulcerative Colitis (UC)
Interventions
- Drug: Mesalamine — also filed as Delzicol
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OFPercentage of Participants Maintaining Clinical Remission Responder Status Based on the modified Mayo Score (mMS)
measured Week 26
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