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PPI Infusion Versus Oral Acid Pump Inhibitors for Bleeding Peptic Ulcers

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Jan 3, 2026 to Jan 2, 2028 Completion date: Jan 3, 2026 to Jul 3, 2028v6 Show 1 more changeShow less
    • Completion date: Jan 3, 2026 to Jul 3, 2028
  2. Re-verified, no change to tracked fieldsv5
  3. Study sites: 1 to 8 Secondary endpoints: details revised at 1 of 2 entriesv4 Show 1 more changeShow less
    • Secondary endpoints: details revised at 1 of 2 entries
  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jan 4, 2023 to May 18, 2023 · Study sites: 0 to 1v3 Show 2 more changesShow less
    • Start date changed from estimate of Jan 4, 2023 to May 18, 2023
    • Study sites: 0 to 1
  5. Enrollment target: 588 to 594v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Vonoprazan (VPZ), an oral potassium-competitive acid blocker (P-CAB) has emerged as an alternative potent acid-suppressant.It has a faster onset of action in 1 day (3-5 days in PPI), and is more stable in acidic condition than PPI. While many studies compared Vonoprazan against PPI in the treatment of reflux oesophagitis, H. Pylori eradication, and gastric ulcers; thus far, there is a paucity of data on use of Vonoprazan on bleeding peptic ulcers. We perform a multicenter randomized controlled trial (RCT) to compare the efficacy of oral Vonoprazan against standard high dose PPI therapy in bleeding peptic ulcers that had received successful endoscopic haemostasis We hypothesize that in patients with bleeding peptic ulcers, the use of acid pump inhibitors Vonoprazan would not be inferior to standard treatment of a bolus plus high dose PPI intravenous infusion at preventing recurrent bleeding after endoscopic haemostasis.
Trial Details
NCT Number NCT05582174
Lead Sponsor Chinese University of Hong Kong
Collaborators: Nanfang Hospital, Southern Medical University
Conditions Upper GI Bleeding, Proton Pump Inhibitors
Enrollment 594 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov