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NCT04314375 · ClinicalTrials.gov registry record · Phase 4
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
A Phase 4 study of Ulcerative Colitis, sponsored by Bausch Health Americas.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 70
- Enrollment target
- 4
- Study locations
NCT04314375: Recruiting Phase 4 study of Ulcerative Colitis, sponsored by Bausch Health Americas.
NCT04314375 is a Phase 4 study of Ulcerative Colitis that is actively recruiting participants, run by Bausch Health Americas. The registered enrollment target is 70 participants, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (97% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04314375, a Phase 4 study of Ulcerative Colitis, is actively recruiting participants, sponsored by Bausch Health Americas.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 70 participants
- Enrollment target
- 4
- Study locations
Study 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.
Primary Outcome
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 s
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Low Dose Budesonide
- DRUG High Dose Budesonide
Study Locations (4)
California
- Bausch Health Site 008 - Garden Grove
Indiana
- Bausch Health Site 003 - Indianapolis
New York
- Bausch Health Site 006 - The Bronx
North Carolina
- Bausch Health Site 010 - Greenville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2023-09-29 |
| Est. Completion | 2027-06 |
| Phase | Phase 4 |
What NCT04314375 shows while recruiting
NCT04314375 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Ulcerative Colitis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT04314375 reports a single indexed study location in California, Indiana, New York.
Frequently Asked Questions
What is clinical trial NCT04314375 about?
NCT04314375 is a clinical study titled "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". 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 ...
What is the current status of trial NCT04314375?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 70 participants. The study started on 2023-09-29. Estimated completion is 2027-06.
What conditions does trial NCT04314375 study?
This clinical trial studies the following conditions: Ulcerative Colitis.
What interventions are being tested in trial NCT04314375?
The interventions under investigation include: Placebo (DRUG), Low Dose Budesonide (DRUG), High Dose Budesonide (DRUG).
Who is sponsoring clinical trial NCT04314375?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04314375 being conducted?
This trial has 4 study locations across California, Indiana, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04314375's enrollment target sits among peer trials
70 72nd of 122 higher than 49 of 122 other Ulcerative Colitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ulcerative Colitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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