Comparing Tegoprazan and Lansoprazole to Heal Bleeding Peptic Ulcers in Adults Over 14 Days

What this Trial Is About

This clinical trial evaluates the effectiveness of two medicines, tegoprazan and lansoprazole, in healing bleeding peptic ulcers in adults in Indonesia. The study focuses on determining which medicine better promotes ulcer healing after 2 weeks of treatment. This research is important because while lansoprazole is a commonly used acid-suppressing drug, tegoprazan represents a newer class that may work more quickly and effectively, but has not been directly compared to lansoprazole for this condition before. Participants will receive initial stabilization with IV fluids and blood transfusions if needed, along with high-dose acid-reducing therapy for the first 72 hours. They will have a gastroscopy within 24 hours of hospital admission for diagnosis and treatment of bleeding. Then, participants will be randomly assigned to take either a 50 mg tegoprazan tablet with a placebo capsule or a 30 mg lansoprazole capsule with a placebo tablet once daily, 30 minutes before breakfast, for 14 days. If they test positive for H. pylori infection, they will receive additional triple therapy. A second gastroscopy will be performed after 14 days to check ulcer healing. Throughout the study, participants will be monitored daily for symptoms and any rebleeding. They will be reminded to take their medication and schedule the follow-up gastroscopy. Researchers will assess the healing of ulcers based on the second gastroscopy and measure the mucosal healing rate 15 days after treatment starts. Safety and rebleeding rates within the 14-day treatment period will also be tracked. The entire participation lasts about two weeks of treatment plus follow-up evaluations.

Tegoprazan Versus Lansoprazole for Endoscopic Ulcer Healing in Bleeding Peptic Ulcers