Tegoprazan And Lansoprazole Effectiveness in Bleeding Peptic Ulcer Treatment

NCT06894992 | Recruiting DMC

• 1 other identifier: 24-12-1819
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Peptic Ulcer Bleeding

Keywords

Tegoprazan; Lansoprazole; Peptic Ulcer; Peptic Ulcer Bleeding; Healing Rate

Outcome Measures

Primary Outcomes (1)

• Healing Rate

  The healing rate will be rated using Forrest Classification

  2 weeks

Study Arms (2)

Potassium Channel Acid Blocker

EXPERIMENTAL

Each randomized patients will consume Tegoprazan 50 mg tab PO OD for 2 weeks

Drug: Tegoprazan

Proton Pump Inhibitor

ACTIVE COMPARATOR

Each randomized patients will consume Lansoprazole 30 mg tab PO OD for 2 weeks

Drug: Lansoprazole

Interventions

Tegoprazan DRUG

Tegoprazan 50 mg tab PO OD in 2 weeks

Also known as: Potassium Channel Acid Blocker, PCAB

Potassium Channel Acid Blocker

Lansoprazole DRUG

Lansoprazole 30 mg tab PO OD in 2 weeks

Also known as: Proton Pump Inhibitor, PPI

Proton Pump Inhibitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mario Steffanus: lead
• Dr Cipto Mangunkusumo General Hospital: collaborator

Study Sites (2)

Cipto Mangunkusumo National General Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

RECRUITING

Atma Jaya Hospital

Jakarta, DKI Jakarta, 14440, Indonesia

RECRUITING

MeSH Terms

Conditions

Peptic Ulcer Hemorrhage; Peptic Ulcer

Interventions

tegoprazan; Lansoprazole; Proton Pump Inhibitors

Condition Hierarchy (Ancestors)

Gastrointestinal Hemorrhage; Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Duodenal Diseases; Intestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Mario Steffanus MD

CONTACT

+6281288002263; mario.steffanus@atmajaya.ac.id

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Gastroenterology and Hepatology Division Trainee

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 26, 2025
• Study Start: May 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-05

Locations

ID (2)