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Feasibility Pilot Sequential Multiple Assignment Randomized Trial (SMART) for Acute Severe Ulcerative Colitis

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 5 months later May 2026 → Nov 2027
Primary endpoints added 7 → 19 primary endpoints
See other at-risk trials from Berinstein, Jeffrey

Record History

  1. Primary and study completion pushed from May 2026 to Nov 2027 Primary endpoint(s) modified · Enrollment increased: 162 → 700 participants · Eligibility criteria expanded, about 136 words · 2 morev7 Show 5 more changesShow less
    • Primary endpoint(s) modified
    • Enrollment increased: 162 → 700 participants
    • Eligibility criteria expanded, about 136 words
    • Secondary endpoints: 6 to 12
    • Study description expanded, about 192 words

    See this version in full on ClinicalTrials.gov ↗

  2. Collaborators expanded, about 10 words Study title expanded, about 6 wordsv6 Show 1 more changeShow less
    • Study title expanded, about 6 words

    See this version in full on ClinicalTrials.gov ↗

  3. Primary endpoints: 6 to 7 Eligibility criteria expanded, about 452 words · Secondary endpoints: 4 to 6v5 Show 2 more changesShow less
    • Eligibility criteria expanded, about 452 words
    • Secondary endpoints: 4 to 6

    See this version in full on ClinicalTrials.gov ↗

  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Sep 2023 to Sep 30, 2023 · Site details revisedv4 Show 2 more changesShow less
    • Start date changed from estimate of Sep 2023 to Sep 30, 2023
    • Site details revised
  5. Start date: Aug 2023 to Sep 2023v3
  6. Start date: May 2023 to Aug 2023v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 goal of this trial is to create personalized treatments for each patient admitted to the hospital with acute severe ulcerative colitis (ASUC). The study will test the feasibility and acceptability of these treatment strategies among patients and physicians so that the study team can later do a larger trial to test whether the medication treatment pathways help patients avoid colectomy while ensuring patient's are safe.
Trial Details
NCT Number NCT05867329
Lead Sponsor Berinstein, Jeffrey
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions Ulcerative Colitis Acute
Enrollment 700 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov