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Dose Ranging Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Rectal Foam in Pediatric Patients Aged 5 to 17 Years With Active, Mild to Moderate Distal Ulcerative Colitis

StatusNot Yet Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Jun 2029 → Jun 2030
See other at-risk trials from Bausch Health Americas, Inc.

Record History

  1. Primary completion pushed from Jun 2029 to Jun 2030 Start date: Jun 2027 to Jun 2029 · Completion pushed from Jan 2030 to Jan 2031 · Eligibility criteria expanded, about 12 words Show 3 more changesShow less
    • Start date: Jun 2027 to Jun 2029
    • Completion pushed from Jan 2030 to Jan 2031
    • Eligibility criteria expanded, about 12 words
  2. Primary completion date: Jun 2025 to Jun 2029 Start date: Jun 2024 to Jun 2027 · Completion date: Jun 2025 to Jan 2030v2 Show 2 more changesShow less
    • Start date: Jun 2024 to Jun 2027
    • Completion date: Jun 2025 to Jan 2030
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The primary objective of this study is to evaluate the efficacy (as measured by induction of remission) of two dose levels (low and high) per age group (5 to \<12 and 12 to ≤17 years) of budesonide rectal foam as compared to an equivalent volume of rectally administered placebo foam over the same dosing schedule, in pediatric subjects with active, mild to moderate distal ulcerative colitis (UC).
Trial Details
NCT Number NCT05976802
Lead Sponsor Bausch Health Americas, Inc.
Conditions Ulcerative Colitis
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov