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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

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Dec 2024 to Dec 2026 Completion date: Dec 2024 to Jun 2027v11 Show 1 more changeShow less
    • Completion date: Dec 2024 to Jun 2027
  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Aug 2023 to Sep 29, 2023 · Site details revised at 4 of 4 sitesv10 Show 2 more changesShow less
    • Start date changed from estimate of Aug 2023 to Sep 29, 2023
    • Site details revised at 4 of 4 sites
  3. Study sites: 0 to 4v9
  4. Start date: Jun 2023 to Aug 2023v8
  5. Start date: Mar 2023 to Jun 2023v7
Show 5 earlier versionsHide 5 earlier versions
  1. Primary and study completion dates: Jun 2023 to Dec 2024 Start date: Dec 2022 to Mar 2023v6 Show 1 more changeShow less
    • Start date: Dec 2022 to Mar 2023
  2. Start date: Jul 2022 to Dec 2022v5
  3. Start date: Apr 2022 to Jul 2022v4
  4. Start date: Apr 2021 to Apr 2022v3
  5. Primary and study completion dates: Jun 2022 to Jun 2023 Start date: Apr 2020 to Apr 2021v2 Show 1 more changeShow less
    • Start date: Apr 2020 to Apr 2021
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
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.
Trial Details
NCT Number NCT04314375
Lead Sponsor Bausch Health Americas, Inc.
Conditions Ulcerative Colitis
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov