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

Peptic ulcer disease, caused by damage to the stomach or duodenal lining from acid or pepsin, affects roughly 5-10% of the global population and has been rising in prevalence worldwide. Standard treatment relies on acid-suppressing drugs, particularly proton pump inhibitors (PPIs) like lansoprazole, which are effective but limited by a short half-life, dependence on food timing, and risks with long-term use such as rebound acid hypersecretion and gut dysbiosis. Potassium-competitive acid blockers (PCABs) such as tegoprazan represent a newer drug class that suppresses acid more rapidly, potently, and predictably than PPIs by directly and reversibly blocking the H+/K+ ATPase pump, without needing an acidic environment for activation. While tegoprazan and other PCABs have shown promising results in healing various types of ulcers and preventing rebleeding after endoscopic treatment, no prior studies have directly compared tegoprazan and lansoprazole specifically in bleeding peptic ulcers, nor evaluated tegoprazan's healing rate at the 2-week mark. This gap makes a head-to-head superiority trial between the two drugs in the Indonesian population both novel and clinically relevant.

All study subjects with symptoms of upper gastrointestinal bleeding and over the age of 18 will receive fluid resuscitation and blood transfusions, if necessary, as well as high-dose PPI therapy, followed by a gastroscopy within 24 hours of admission for initial assessment and a biopsy for H. pylori testing. If H. pylori infection is detected, triple therapy will be administered, consisting of amoxicillin 1000 mg twice a day, clarithromycin 500 mg twice a day, and a PPI or PCAB for 14 days.

All study subjects were randomly assigned using concealment methods prepared by the data processing team and divided into two groups based on the type of treatment to be administered. The first group received tegoprazan 50 mg in the morning, and the second group received lansoprazole 30 mg in the morning. Tegoprazan is in tablet form, and there is no data on its stability when made into capsules; therefore, this study used a double dummy for tegoprazan and lansoprazole.

The first group will receive one 50 mg tegoprazan tablet and one dummy capsule, while the second group will receive one 30 mg lansoprazole capsule and one dummy tablet. Both capsules and tablets are made identical in active and dummy form. Both medications will be taken together half an hour before breakfast to enhance effectiveness.

Each subject's allocation will be placed in a sealed envelope containing the treatment group number, with the subject's serial number written on the outside of the envelope. After 72 hours of high-dose PPI administration and the absence of hematemesis or melena, the data collection team will administer 17 sets of medications according to the treatment group number listed in the sealed envelope to the study subjects.