Tegoprazan And Lansoprazole Effectiveness in Bleeding Peptic Ulcer Treatment (TALENT)

A Comparison of The Effectiveness of Tegoprazan and Lansoprazole in Achieving Cure Rates in Patients With Bleeding Peptic Ulcers: A Double-Blind Randomized Trial

The goal of this clinical trial is to compare the effects of tegoprazan vs lansoprazole in healing bleeding peptic ulcers. It will also teach about the safety of both modalities. The main questions it aims to answer are:

How does the effectiveness of Tegoprazan compare with Lansoprazole in two weeks of healing rate bleeding peptic ulcer patients in the Indonesian population?

Researchers will compare the drug tegoprazan to lansoprazole with a double-blind randomized control to see their effect on healing bleeding peptic ulcers.

Participants will:

Take drug tegoprazan 50 mg OD or lansoprazole 30 mg OD every day for 2 weeks Endoscopic examination at the beginning before treatment and after completion of treatment within 2 weeks Record of their adverse effect occurrence

Study Overview

• Status: Recruiting
• Conditions: Peptic Ulcer Bleeding
• Intervention / Treatment: Drug: Tegoprazan; Drug: Lansoprazole

Detailed Description

Peptic ulcer disease (PUD) is a condition characterized by disruption of the gastric and duodenal mucosal lining due to exposure to gastric acid or pepsin. Major causes include Helicobacter pylori infection, nonsteroidal anti-inflammatory drug (NSAID) use, gastric bypass surgery, lifestyle factors such as smoking and alcohol consumption, and genetic predisposition. PUD affects 5-10% of the global population and poses a significant healthcare burden, with prevalence rising from 6.43 million to 8.09 million cases between 1990 and 2019.

Current PUD treatment involves acid-suppressing agents and H. pylori eradication when indicated. Proton pump inhibitors (PPIs) play a key role by irreversibly inhibiting H⁺/K⁺ ATPase in gastric parietal cells, effectively maintaining gastric pH ≥4, which is essential for ulcer healing and preventing complications like bleeding. Lansoprazole, a widely used PPI, has demonstrated strong efficacy, with healing rates of 64%, 75.6%, and 95.7% at 2, 4, and 8 weeks, respectively. However, PPIs have limitations, including short plasma half-life, food dependency, breakthrough symptoms, and potential long-term adverse effects such as hypergastrinemia, acid rebound, and gut microbiota alterations.

To overcome these limitations, potassium-competitive acid blockers (PCABs) like vonoprazan and tegoprazan have been developed. PCABs provide faster, more stable, and potent acid suppression compared to PPIs. Unlike PPIs, which require activation in an acidic environment, PCABs directly inhibit H⁺/K⁺ ATPase by competitively binding to potassium sites, offering more predictable pharmacokinetics. Tegoprazan, a newer PCAB, has demonstrated superior acid suppression and a faster onset of action than vonoprazan, making it highly relevant for ulcer healing and preventing nocturnal acid breakthrough.

Studies suggest that PCABs are non-inferior to PPIs in treating PUD, with some data indicating that tegoprazan offers stronger, faster, and more stable acid suppression than vonoprazan. However, no studies have compared the healing rates of tegoprazan and lansoprazole specifically in bleeding PUD patients over a 2-week treatment period. Given the importance of optimizing treatment for bleeding PUD in Indonesia, this study aims to compare the effectiveness of tegoprazan and lansoprazole in ulcer healing over a short-term evaluation period.

This research is expected to contribute to the scientific literature by providing clinical trial data specific to the Indonesian population, inform clinical decision-making by identifying the most effective treatment for bleeding PUD, and ultimately improve patient outcomes by ensuring faster healing and better symptom management.

• Study Type: Interventional
• Enrollment (Estimated): 162
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mario Steffanus MD; Phone Number: +6281288002263; Email: mario.steffanus@atmajaya.ac.id

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta, DKI Jakarta, Indonesia, 10430
      • Recruiting
      • Cipto Mangunkusumo National General Hospital
      • Contact: Achmad Fauzi, MD; Phone Number: +6281386668655; Email: ppfauzidrgm@gmail.com
    • Jakarta, DKI Jakarta, Indonesia, 14440
      • Recruiting
      • Atma Jaya Hospital
      • Contact: Mario Steffanus MD; Phone Number: +6281288002263; Email: mario.steffanus@atmajaya.ac.id

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subjects diagnosed with upper gastrointestinal bleeding caused by peptic ulcer through gastroscopic examination

Exclusion Criteria:

• Allergic to Tegoprazan or Lansoprazole
• Diagnosed with gastric or duodenal cancer, pregnant
• History of H. pylori infection treatment failure
• Presence of comorbidities such as chronic kidney disease or decompensated liver cirrhosis
• Alcohol consumption
• Undergoing chemotherapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Potassium Channel Acid Blocker; Each randomized patients will consume Tegoprazan 50 mg tab PO OD for 2 weeks	Drug: Tegoprazan; Tegoprazan 50 mg tab PO OD in 2 weeks; Other Names: Potassium Channel Acid Blocker; PCAB
Active Comparator: Proton Pump Inhibitor; Each randomized patients will consume Lansoprazole 30 mg tab PO OD for 2 weeks	Drug: Lansoprazole; Lansoprazole 30 mg tab PO OD in 2 weeks; Other Names: PPI; Proton Pump Inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healing Rate	The healing rate will be rated using Forrest Classification	2 weeks

Collaborators and Investigators

• Sponsor: Mario Steffanus
• Collaborators: Dr Cipto Mangunkusumo General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 19, 2025
• First Submitted That Met QC Criteria: March 19, 2025
• First Posted (Actual): March 26, 2025

Study Record Updates

• Last Update Posted (Actual): May 29, 2025
• Last Update Submitted That Met QC Criteria: May 23, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Lansoprazole; Peptic Ulcer; Peptic Ulcer Bleeding; Tegoprazan; Healing Rate
• Additional Relevant MeSH Terms: Pathologic Processes; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Duodenal Diseases; Gastrointestinal Hemorrhage; Ulcer; Hemorrhage; Peptic Ulcer; Peptic Ulcer Hemorrhage; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Enzyme Inhibitors; Anti-Ulcer Agents; Proton Pump Inhibitors; Dexlansoprazole; Lansoprazole
• Other Study ID Numbers: 24-12-1819

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No