drugset / Trial / NCT07708545

Tegoprazan Versus Lansoprazole for Endoscopic Ulcer Healing in Bleeding Peptic Ulcers

NCT07708545

Phase 2 Not yet recruiting 162 enrolled Indonesia University
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This clinical trial compares two medicines used to treat bleeding stomach ulcers in people in Indonesia. The researchers want to find out whether tegoprazan or lansoprazole is better at healing these ulcers after 2 weeks of treatment. The main question this trial aims to answer is: Which medicine, tegoprazan or lansoprazole, heals bleeding peptic ulcers better after 2 weeks of treatment? Researchers will compare tegoprazan to lansoprazole to see which one works better. Participants in this trial will: * Receive IV fluids and, if needed, a blood transfusion to stabilize their condition * Receive a high dose of acid-reducing medicine for the first 72 hours * Have an exam of the stomach using a thin scope (gastroscopy) within 24 hours of arriving at the hospital, with treatment to stop the bleeding if needed * Take one of two combinations once a day, 30 minutes before breakfast, for 14 days: either lansoprazole (30 mg) plus a tegoprazan placebo, or tegoprazan (50 mg) plus a lansoprazole placebo. A placebo looks identical to the real drug but contains no active medicine. Neither participants nor researchers will know which one each person is taking. * Be treated for H. pylori - a stomach bacteria that can cause ulcers - if they test positive for it * Have a second gastroscopy after 14 days of treatment to check how well the ulcer has healed

Timeline

Start
2026-07-15
Primary completion
2026-12-31
Completion
2027-02-28

Drugs

EvaluationDrugModalityDoseRoute
Comparator Lansoprazole Other / unclassified 30 mg Oral
Subject Tegoprazan Other / unclassified 50 mg Oral

Indications