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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04314375
Other study ID # BUUC4991
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date September 29, 2023
Est. completion date December 2024

Study information

Verified date October 2023
Source Bausch Health Americas, Inc.
Contact Sandra Narain
Phone 9082428287
Email sandra.narain@bauschhealth.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a randomized, double-blind, placebo-controlled, multicenter, study to evaluate the efficacy, safety, and pharmacokinetics (PK) of budesonide extended-release tablets for the induction of remission in pediatric subjects, with active, mild to moderate ulcerative colitis (UC). Subjects will be permitted to continue taking background oral or rectal 5-aminosalicylate (5-ASA) products.


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 5 Years to 17 Years
Eligibility Inclusion Criteria: - Established diagnosis of UC is based on: - Clinical history - Characteristic endoscopic findings - Histopathology results from biopsies - Age 5 to 17 years, inclusive, at Screening. Subjects should weigh greater than 13.6 kg at Baseline. - Active UC of mild or moderate severity, defined as a total Mayo score between 4 and 10, inclusive, with rectal bleeding subscore of = 1, stool frequency subscore of =1 and an endoscopy subscore of = 1. - If on a background oral or rectal 5-ASA, the dose and formulation have remained unchanged for at least 6 weeks prior to Visit 2 (randomization), Baseline and the subject is willing to remain on the same formulation and dose for the duration of the study. Exclusion Criteria: 1. Current or prior diagnosis of Crohn's disease or indeterminate colitis. 2. Limited distal proctitis (disease involving only the first 15 centimeters or less proximal to the anal verge. 3. Severe UC, defined as total Mayo score >10. 4. Not currently in an active phase or flare, defined as a total Mayo score <4, or Mayo score between 4 and 10, but Mayo subscore of 0 for rectal bleeding, stool frequency or endoscopy. 5. Infectious colitis (based on positive microbiologic tests at Screening) or any recent history of infectious colitis (within 30 days prior to Screening). 6. Prior gastrointestinal surgery, except appendectomy or hernia (e.g., inguinal, umbilical). NOTE: Prior cholecystectomy is not exclusionary if more than 1 year prior to Screening. 7. Evidence or history of toxic megacolon or bowel resection.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Low Dose Budesonide
3 milligrams once daily for ages 5 to 11 years 11 months. 6 milligrams once daily for ages 12 to 17 years.
High Dose Budesonide
6 milligrams once daily for ages 5 to 11 years 11 months. 9 milligrams once daily for ages 12 to 17 years.
Placebo
Matching placebo once daily.

Locations

Country Name City State
United States Bausch Health Site 006 Bronx New York
United States Bausch Health Site 008 Garden Grove California
United States Bausch Health Site 010 Greenville North Carolina
United States Bausch Health Site 003 Indianapolis Indiana

Sponsors (1)

Lead Sponsor Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The primary efficacy endpoint is the proportion of subjects who achieve clinical remission at Day 56, defined as a total Mayo score of = 1 with subscores of 0 for both rectal bleeding and stool frequency, and a subscore of = 1 for endoscopy. The primary efficacy endpoint is the proportion of subjects who achieve clinical remission at Day 56, defined as a total Mayo score of = 1 with subscores of 0 for both rectal bleeding and stool frequency, and a subscore of = 1 for endoscopy. The Mayo score is a composite index score based on 4 components: stool frequency (subject reported), rectal bleeding (subject reported), findings of endoscopy, and the physician's rating of disease activity. Each component is scored from 0 to 3, with total scores range from 0 to 12 with higher scores indicating more severe disease. 56 days
Secondary Proportion of subjects who achieve a Mayo rectal bleeding subscale score of 0 at Day 56. Proportion of subjects who achieve a Mayo rectal bleeding subscale score of 0 at Day 56. The Mayo score is a composite index score based on 4 components: stool frequency (subject reported), rectal bleeding (subject reported), findings of endoscopy, and the physician's rating of disease activity. Each component is scored from 0 to 3, with total scores range from 0 to 12 with higher scores indicating more severe disease. 56 days
Secondary Proportion of subjects who achieve a Mayo stool frequency subscale score of 0 at Day 56. Proportion of subjects who achieve a Mayo stool frequency subscale score of 0 at Day 56. The Mayo score is a composite index score based on 4 components: stool frequency (subject reported), rectal bleeding (subject reported), findings of endoscopy, and the physician's rating of disease activity. Each component is scored from 0 to 3, with total scores range from 0 to 12 with higher scores indicating more severe disease. 56 days
Secondary Proportion of subjects who achieve a Mayo endoscopy subscale score of 0 or 1 at Day 56. Proportion of subjects who achieve a Mayo endoscopy subscale score of 0 or 1 at Day 56. The Mayo score is a composite index score based on 4 components: stool frequency (subject reported), rectal bleeding (subject reported), findings of endoscopy, and the physician's rating of disease activity. Each component is scored from 0 to 3, with total scores range from 0 to 12 with higher scores indicating more severe disease. 56 days
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