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
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 hospital admission or after clinical stabilization when the patient was deemed fit to undergo esophagogastroduodenoscopy (EGD). Endoscopic hemostatic therapy was performed when indicated. * 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
• Subjects aged 18 years and over.
• Subjects with upper gastrointestinal bleeding caused by peptic ulcers diagnosed by gastroscopy.
• Willing to participate in the entire clinical study process, including:
‣ . Fluid resuscitation and blood transfusion, if necessary,
⁃ . High-dose PPI therapy for 72 hours,
⁃ . Gastroscopy within 24 hours of hospital admission and endoscopic hemostatic therapy, if necessary,
⁃ . Lansoprazole 30 mg or tegoprazan 50 mg therapy for 14 days,
⁃ . Treatment for H. pylori infection if positive,
⁃ . Repeat gastroscopy after 14 days of treatment to assess the progress of therapy.