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Rectal Indomethacin as Early Treatment for Acute Pancreatitis (INDOMAP Trial)

Study acronym: INDOMAP
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date: Jun 1, 2024 to Dec 1, 2024 Primary endpoint revised · Enrollment target: 1428 to 1504 · Completion date: Jun 1, 2030 to Dec 1, 2028 · 1 morev7 Show 4 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 1428 to 1504
    • Completion date: Jun 1, 2030 to Dec 1, 2028
    • Eligibility criteria shortened, about 8 words

    See this version in full on ClinicalTrials.gov ↗

  2. Phase: Phase 3 to Phase 4 Enrollment target: 240 to 1428 · Primary completion date: Jul 1, 2020 to Jun 1, 2028 · Start date: Jul 1, 2018 to Jun 1, 2024 · 4 morev6 Show 7 more changesShow less
    • Enrollment target: 240 to 1428
    • Primary completion date: Jul 1, 2020 to Jun 1, 2028
    • Start date: Jul 1, 2018 to Jun 1, 2024
    • Study sites: 1 to 17
    • Completion date: Jul 30, 2020 to Jun 1, 2030
    • Eligibility criteria revised
    • Study title expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  3. Re-verified, no change to tracked fieldsv5
  4. Start date: Jun 1, 2018 to Jul 1, 2018 Primary completion date: Jun 1, 2020 to Jul 1, 2020 · Completion date: Jun 30, 2020 to Jul 30, 2020v4 Show 2 more changesShow less
    • Primary completion date: Jun 1, 2020 to Jul 1, 2020
    • Completion date: Jun 30, 2020 to Jul 30, 2020
  5. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1v3 Show 1 more changeShow less
    • Study sites: 0 to 1
  6. Eligibility criteria shortened, about 3 words Study title shortened, about 2 wordsv2 Show 1 more changeShow less
    • Study title shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Acute pancreatitis (AP) is an inflammatory condition of the pancreas following the activated pancreatic enzymes induced by varied causes, with or without other organ(s) dysfunction. The production and release of inflammatory factors is generally considered as the key factor of pathogenesis. Non-steroidal anti-inflammatory drugs (NSAIDs) are the most commonly applied agents for inflammatory diseases. A series studies have proved that indomethacin can reduce the risk of post-endoscopic retrograde cholangiopancreatography (ERCP), but high-quality evidence is still lacking in the field of effectiveness of NSAIDs to treat, rather than prevent, other types of AP. Majority of animal experiments showed that NSAIDs had protective effects for organ functions, but the results of several preliminary clinical studies were inconsistent. Randomized controlled trials are eagerly awaited to elucidate its effects on AP.
Trial Details
NCT Number NCT03547232
Lead Sponsor Peking Union Medical College Hospital
Conditions Acute Pancreatitis, Complication, Mortality Rate, Organ Failure, Multiple
Enrollment 1,504 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov