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Tegoprazan Versus Lansoprazole for Endoscopic Ulcer Healing in Bleeding Peptic Ulcers
Sponsor: Indonesia University
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
Official title: A Double-Blind, Double-Dummy, Randomized Controlled Trial Comparing 14-Day Tegoprazan Versus Lansoprazole Therapy for Endoscopic Ulcer Healing in Patients With Bleeding Peptic Ulcers
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
162
Start Date
2026-07-15
Completion Date
2027-02-28
Last Updated
2026-07-16
Healthy Volunteers
No
Conditions
Interventions
Tegoprazan tablet
50 mg tegoprazan tablet + matching lansoprazole placebo, once a day, 30 minutes before breakfast, for 14 days
Lansoprazole capsules
30 mg lansoprazole capsule + matching tegoprazan placebo, once a day, 30 minutes before breakfast, for 14 days
Locations (3)
RSUD Balaraja
Tangerang, Banten, Indonesia
RSUPN Dr. Cipto Mangunkusumo
Jakarta Pusat, DKI Jakarta, Indonesia
RSUP Dr. M. Djamil
Padang, West Sumatra, Indonesia