Status:
WITHDRAWN
A Study to Assess Adverse Events and Change in Disease Condition of Mesalamine Capsules in Children Aged 5 to 17 Years With Ulcerative Colitis
Lead Sponsor:
AbbVie
Conditions:
Ulcerative Colitis (UC)
Eligibility:
All Genders
5-17 years
Phase:
PHASE3
Brief Summary
Ulcerative colitis (UC) is a type of inflammatory bowel disease (IBD) characterized by diffuse, continuous inflammation of the colon. This study will assess how safe and effective mesalamine delayed-r...
Eligibility Criteria
Inclusion
- \- Documented history of Ulcerative Colitis (UC) who have been successfully maintained in remission for at least 30 days prior to the screening visit and are on a stable dose of mesalamine or 5-aminosalicylic acid equivalent.
Exclusion
- \- Abnormal and clinically significant results according to the investigator or designee, on physical examination, medical history, electrocardiogram (ECG), hematology, clinical chemistry, or urinalysis.
Key Trial Info
Start Date :
September 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 19 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05316220
Start Date
September 15 2025
End Date
July 19 2026
Last Update
August 12 2025
Active Locations (10)
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1
Childrens National /ID# 243379
Washington D.C., District of Columbia, United States, 20010-2916
2
Angel Kids Pediatrics /ID# 244874
Jacksonville, Florida, United States, 32225-3131
3
Treken Primary Care /ID# 241302
Atlanta, Georgia, United States, 30315
4
Eagle Clinical Research /ID# 242045
Chicago, Illinois, United States, 60621