A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE SAFETY, EFFICACY, AND PHARMACOKINETICS OF BUDESONIDE EXTENDED-RELEASE TABLETS ADMINISTERED ONCE DAILY IN PEDIATRIC SUBJECTS AGED 5 TO 17 YEARS WITH ACTIVE, MILD TO MODERATE ULCERATIVE COLITIS
M
Marian Pfefferkorn
Primary Investigator
Enrolling By Invitation
5 years - 17 years
All
Phase
N/A
3 Locations
Brief description of study
The primary objective of this study is to evaluate the efficacy and safety of a low and a high dose of budesonide extended-release tablets in pediatric subjects with active, mild to moderate UC.
During the study, partiicpants (or their parent / guardian, as appropriate) will be required to document their
disease symptoms in a daily diary from the Screening period, through Day 56. All enrolled participants will have blood samples collected for budesonide concentrations. Participants will visit the clinical center six times over the course of the study.
During the study, partiicpants (or their parent / guardian, as appropriate) will be required to document their
disease symptoms in a daily diary from the Screening period, through Day 56. All enrolled participants will have blood samples collected for budesonide concentrations. Participants will visit the clinical center six times over the course of the study.
Eligibility
- Must be 5-17 years of age
- Established diagnosis of ulcerative colitis (UC)
- Additonal criteria must be met based on determination by Investigator and study requirements
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: ulcerative colitis,uc, Riley
-
Age: 5 years - 17 years
-
Gender: All
Updated on
13 Sep 2024.
Study ID: PGI-SALIX-BUUC4991, 2003733472, TX11540
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