Tegoprazan Versus Lansoprazole for Endoscopic Ulcer Healing in Bleeding Peptic Ulcers

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Peptic Ulcer Bleeding

In brief

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

Key facts

Study ID

NCT07708545

Run by

Indonesia University

People needed

162

Starts

2026-08-06

Expected to finish

2027-02-28

Last updated by the study team

2026-08-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Subjects with a history of allergy to tegoprazan or lansoprazole
• Subjects with a history of allergy to tegoprazan or lansoprazole.
• Subjects with ulcers caused by gastric or duodenal cancer.
• Subjects with comorbidities such as chronic kidney disease stage 3 or higher and decompensated liver cirrhosis.
• Patients who are heavy alcohol drinkers and have used chemotherapy drugs, bisphosphonates, or potassium supplements in the past 2 weeks.

Where it is running

• RSUPN Dr. Cipto Mangunkusumo — Jakarta Pusat, DKI Jakarta, Indonesia (enrolling)
• RSUD Balaraja — Tangerang, Banten, Indonesia
• RSUP Dr. M. Djamil — Padang, West Sumatra, Indonesia

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.