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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
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-release capsules are in treating pediatric participants with UC. Adverse events and change in disease activity will be assessed. Delzicol (Mesalamine) is an approved drug being developed for the treatment of Ulcerative Colitis (UC). Study doctors put the participants in 1 of 2 groups, called treatment arms. Each group receives a different treatment. Around 80 Pediatric participants aged 5 to 17 years with a diagnosis of UC will be enrolled in approximately 45 sites in the United States. Participants will receive oral mesalamine capsules twice daily for 26 weeks and followed for 30 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Age
5 - 17 years
Sex
ALL
Healthy Volunteers
No
Childrens National /ID# 243379
Washington D.C., District of Columbia, United States
Angel Kids Pediatrics /ID# 244874
Jacksonville, Florida, United States
Treken Primary Care /ID# 241302
Atlanta, Georgia, United States
Eagle Clinical Research /ID# 242045
Chicago, Illinois, United States
Virgo Carter Pediatrics /ID# 241556
Silver Spring, Maryland, United States
UH Cleveland Medical Center /ID# 243375
Cleveland, Ohio, United States
Children's Hospital Oklahoma /ID# 242614
Oklahoma City, Oklahoma, United States
Carilion Medical Center /ID# 244398
Roanoke, Virginia, United States
San Juan Bautista School of Medicine /ID# 243377
Caguas, Puerto Rico
Centro de Investigaciones Clinicas San Jorge Children's and Women's Hospital /ID# 244595
San Juan, Puerto Rico
Start Date
September 15, 2025
Primary Completion Date
July 19, 2026
Completion Date
July 19, 2026
Last Updated
August 12, 2025
Mesalamine
DRUG
Placebo
DRUG
Lead Sponsor
AbbVie
NCT07271069
NCT07245394
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07333716