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

Part of paid clinical trials in Garden Grove, California.

Sponsor
Bausch Health Americas, Inc.
Study ID
NCT04314375
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
5 Years - 17 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Sep 29, 2023
Status verified
Sep 2025
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Low Dose Budesonide
  • Experimental: High Dose Budesonide
  • Placebo Comparator: Placebo

Primary Outcome Measure

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. [ Time Frame: 56 days ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Bausch Health Site 008Garden GroveCalifornia92845-
Bausch Health Site 003IndianapolisIndiana46202-
Bausch Health Site 006The BronxNew York10467-
Bausch Health Site 010GreenvilleNorth Carolina27834-

Find similar trials in Garden Grove, CA

By condition
Ulcerative colitis
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Bausch Health· Garden Grove, CABausch Health· Indianapolis, INBausch Health· The Bronx, NYBausch Health· Greenville, NC

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