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NOT YET RECRUITING
NCT07708545
PHASE2

Tegoprazan Versus Lansoprazole for Endoscopic Ulcer Healing in Bleeding Peptic Ulcers

Sponsor: Indonesia University

View on ClinicalTrials.gov

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

Interventions

DRUG

Tegoprazan tablet

50 mg tegoprazan tablet + matching lansoprazole placebo, once a day, 30 minutes before breakfast, for 14 days

DRUG

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