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Efficacy and Safety of Tegoprazan and Minocycline Dual Therapy for Helicobacter Pylori Initial Treatment

StatusActive, Not Recruiting
PhasePhase 4
Started
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Record status
This record was last updated July 3, 2025 (before its estimated August 1, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Dec 2024 to Aug 1, 2025v3 Show 4 more changesShow less
    • Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Study sites: 0 to 1
    • Study completion date: Jan 2025 to Oct 1, 2025
    • Start date changed from estimate of Sep 2024 to Nov 11, 2024
  2. Primary endpoint revised
    • Secondary endpoints revised (2)
    • Study title shortened, about 5 words
    v2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 purpose of this study was to evaluate the efficacy and safety of tegoprazan and minocycline dual therapy for Helicobacter pylori initial treatment. It is hypothesized that tegoprazan and minocycline dual therapy is non-inferior to bismuth-containing quadruple therapy.Patients diagnosed with H. pylori infection will be randomly divided into one of the above treatments. At week 6 follow-up visits, a urea breath test#rapid urease test or helicobacter pylori stool antigen test will be performed to confirm eradication.
Trial Details
NCT Number NCT06523764
Lead Sponsor Xijing Hospital of Digestive Diseases
Conditions
(from sponsor)		 Helicobacter Pylori Infection Chronic Gastrit
Enrollment 208 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov