Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04314375
The ClinicalTrials.gov registry entry for NCT04314375 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (97% lower). The listed sponsor is Bausch Health Americas, which has 168 total studies on file at ClinicalTrials.gov.
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 4 study locations spanning 4 distinct geographic areas - top geographies include 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.
Learn More About Clinical Trials
Similar trials for Ulcerative Colitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC)
RECRUITING · Phase 4
-
A Study of Vedolizumab in Adults With Ulcerative Colitis or Crohn's Disease in the Community Setting
RECRUITING · Phase 4
-
Proactive Infliximab Optimization Using a Pharmacokinetic Dashboard Versus Standard of Care in Patients With Inflammatory Bowel Disease: The OPTIMIZE Trial
ACTIVE NOT RECRUITING · Phase 4
-
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of RO7837195 in Participants With Moderately to Severely Active Ulcerative Colitis (UC)
RECRUITING · Phase 2
-
Study of Efficacy and Adherence to Subcutaneous vs. Intravenous Vedolizumab in Patients With Inflammatory Bowel Disease Using a Novel Remote MONITORing Intervention
RECRUITING
-
Treat-to-Target of Endoscopic Remission in Patients With IBD in Symptomatic Remission
RECRUITING · NA
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.