RECRUITING

Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets n Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis

Quick Facts

Study Start:2023-09-29

Study Completion:2024-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04314375

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:5 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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.	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). 7. Evidence or history of toxic megacolon or bowel resection.

Inclusion Criteria

Exclusion 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.

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).
7. Evidence or history of toxic megacolon or bowel resection.

Contacts and Locations

Study Contact

Sandra Narain

CONTACT

9082428287

sandra.narain@bauschhealth.com

Principal Investigator

Varsha Bhatt

STUDY_DIRECTOR

Bausch Health

Study Locations (Sites)

Bausch Health Site 008

Garden Grove, California, 92845

United States

Bausch Health Site 003

Indianapolis, Indiana, 46202

United States

Bausch Health Site 006

Bronx, New York, 10467

United States

Bausch Health Site 010

Greenville, North Carolina, 27834

United States

Collaborators and Investigators

Sponsor: Bausch Health Americas, Inc.

Varsha Bhatt, STUDY_DIRECTOR, Bausch Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-29

Study Completion Date2024-12

Study Record Updates

Study Start Date2023-09-29

Study Completion Date2024-12

Terms related to this study

Additional Relevant MeSH Terms

Ulcerative Colitis