A Study to Assess Adverse Events and Change in Disease Condition of Mesalamine Capsules in Children Aged 5 to 17 Years With Ulcerative Colitis

Study Identifier
M21-517
CT.gov Identifier
NCT05316220
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Study Details

Medical Condition
  • Ulcerative Colitis (UC)
    • Study Drug
  • Mesalamine
  • Placebo
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    5 - 17 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    \- 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 Criteria:
    \- Abnormal and clinically significant results according to the investigator or designee, on physical examination, medical history, electrocardiogram (ECG), hematology, clinical chemistry, or urinalysis.

    Protocol 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-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.

    Study Locations

    Location
    Status
    Location
    Childrens National /ID# 243379
    Washington D.C., District of Columbia, United States, 20010-2916
    Status
    Not applicable
    Location
    Angel Kids Pediatrics /ID# 244874
    Jacksonville, Florida, United States, 32225-3131
    Status
    Not applicable
    Location
    Treken Primary Care /ID# 241302
    Atlanta, Georgia, United States, 30315
    Status
    Not applicable
    Location
    Eagle Clinical Research /ID# 242045
    Chicago, Illinois, United States, 60621
    Status
    Not applicable
    Location
    Virgo Carter Pediatrics /ID# 241556
    Silver Spring, Maryland, United States, 20910
    Status
    Not applicable
    Location
    UH Cleveland Medical Center /ID# 243375
    Cleveland, Ohio, United States, 44106
    Status
    Not applicable
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