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Prevention of Recurrent Ulcer Bleeding in Patients With Idiopathic Gastroduodenal Ulcer

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Dec 31, 2023 to Dec 31, 2026 Completion date: Dec 31, 2024 to Mar 31, 2027v6 Show 1 more changeShow less
    • Completion date: Dec 31, 2024 to Mar 31, 2027
  2. Primary completion date: May 30, 2021 to Dec 31, 2023 Completion date: May 30, 2022 to Dec 31, 2024 · Eligibility criteria shortened, about 2 words · Study description shortened, about 1 wordv5 Show 3 more changesShow less
    • Completion date: May 30, 2022 to Dec 31, 2024
    • Eligibility criteria shortened, about 2 words
    • Study description shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. 2 versions Re-verified since Jan 22, 2020, no change to tracked fieldsv3-v4
  4. Interventions: Misoprostol+Lansoprazole (Drug), Placebo +Lansoprazole (Drug) to Misoprostol Oral Tablet (Drug), Placebo Oral Tablet (Drug)v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Patients with a history of idiopathic gastroduodenal ulcer bleeding face an increased risk of recurrent ulcer gastrointestinal bleeding. Our ongoing clinical trial demonstrates a possible reduced risk of recurrent idiopathic gastroduodenal ulcer bleeding with proton pump inhibitor (PPI), yet there is a significant risk of recurrent ulcer bleeding as PPI may increase the risk of small bowel bleeding. Our preliminary data provide strong plausibility that a combination therapy of misoprostol (MISO) with a PPI reduces the recurrent ulcer bleeding as well as clinical gastrointestinal bleeding. The investigators are going to provide the definitive answer to this important clinical question through a randomised trial.
Trial Details
NCT Number NCT03675672
Lead Sponsor Chinese University of Hong Kong
Conditions Active Peptic Ulcer Disease/GI Bleeding
Enrollment 154 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov