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
Phase 4 · Testing Low Dose Budesonide and High Dose Budesonide · 4 sites · Bausch Health Americas, Inc.
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Low Dose Budesonide (a drug) and High Dose Budesonide (a drug) as a possible treatment. Condition(s) listed: Ulcerative Colitis.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
Phase 4 studies look at treatments that are already approved, to learn more about how they work in everyday use.
Who can join
- Ages 5 to 17
- Any sex
Some of the main requirements, copied from the record:
- Established diagnosis of UC is based on:
- Clinical history
- Characteristic endoscopic findings
Plus 4 more requirement(s). There are also 8 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 70 participants are expected to take part.
- Start date: 2023-09-29.
- Main results expected around 2026-12 (estimate from the record).
- 4 study sites listed (4 marked recruiting) in United States.
Main thing being measured
- 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… (56 days)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 4 |
| Study type | Interventional |
| Conditions | Ulcerative Colitis |
| Lead sponsor | Bausch Health Americas, Inc. |
| Enrollment | 70 (estimated) |
| Start date | 2023-09-29 |
| Primary completion (est.) | 2026-12 |
| First posted | 2020-03-19 |
| Last updated | 2025-09-16 |
| 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 |
| ClinicalTrials.gov ID | NCT04314375 |
Interventions
- Low Dose Budesonide (Drug)
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 (Drug)
6 milligrams once daily for ages 5 to 11 years 11 months. 9 milligrams once daily for ages 12 to 17 years. - Placebo (Drug)
Matching placebo once daily.
Full eligibility criteria (from the record)
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.
Locations (4)
| Site | City | Country | Site status |
|---|---|---|---|
| Bausch Health Site 008 | Garden Grove, California | United States | Recruiting |
| Bausch Health Site 003 | Indianapolis, Indiana | United States | Recruiting |
| Bausch Health Site 006 | The Bronx, New York | United States | Recruiting |
| Bausch Health Site 010 | Greenville, North Carolina | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.