Tegoprazan Versus Lansoprazole for Endoscopic Ulcer Healing in Bleeding Peptic Ulcers

NCT07708545 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 174/UN2.F1/ETIK/PPM.00.02/2025
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 3

Brief Summary

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 arriving at the hospital, with treatment to stop the bleeding if needed
• 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

Conditions

Peptic Ulcer Bleeding

Keywords

Tegoprazan; Lansoprazole; ulcer healing; peptic ulcer bleeding; randomized-controlled trial; double-blind; double-dummy

Outcome Measures

Primary Outcomes (1)

• Mucosal Healing Rate

  Percentage of participants achieving mucosal healing, defined as complete healing of the ulcer with re-epithelialized (normal) mucosa at the ulcer site, assessed endoscopically.

  Day 15 after treatment initiation

Secondary Outcomes (1)

• Rebleeding Rate

  Within 14 days after treatment initiation

Other Outcomes (1)

• Predictors of Mucosal Healing

  Day 15 after treatment initiation

Study Arms (2)

Tegoprazan

EXPERIMENTAL

Participants take a 50 mg tegoprazan tablet together with a matching lansoprazole placebo, once a day, 30 minutes before breakfast, for 14 days.

Drug: Tegoprazan tablet

Lansoprazole

ACTIVE COMPARATOR

Participants take a 30 mg lansoprazole tablet together with a matching tegoprazan placebo, once a day, 30 minutes before breakfast, for 14 days.

Drug: Lansoprazole capsules

Interventions

Tegoprazan tablet DRUG

50 mg tegoprazan tablet + matching lansoprazole placebo, once a day, 30 minutes before breakfast, for 14 days

Also known as: Tegoprazan, P-CAB

Tegoprazan

Lansoprazole capsules DRUG

30 mg lansoprazole capsule + matching tegoprazan placebo, once a day, 30 minutes before breakfast, for 14 days

Also known as: Lansoprazole, PPI

Lansoprazole

Eligibility Criteria

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

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.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (3)

RSUD Balaraja

Tangerang, Banten, 15610, Indonesia

Location

RSUPN Dr. Cipto Mangunkusumo

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

RSUP Dr. M. Djamil

Padang, West Sumatra, 25129, Indonesia

Location

MeSH Terms

Conditions

Peptic Ulcer Hemorrhage

Interventions

tegoprazan; Lansoprazole

Condition Hierarchy (Ancestors)

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

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

Study Officials

• Hasan Maulahela, MD, PhD

  Indonesia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

dr. Hasan Maulahela, Sp.PD-KGEH, MD, PhD

CONTACT

+6281283602549; aspendrhasanmaulahela@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Head of Gastroenterology Division

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 16, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ID (3)