MedTrace Logo

Tegoprazan Versus Lansoprazole for Endoscopic Ulcer Healing in Bleeding Peptic Ulcers

NCT07708545 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2026-08-10

No results posted yet for this study

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 hospital admission or after clinical stabilization when the patient was deemed fit to undergo esophagogastroduodenoscopy (EGD). Endoscopic hemostatic therapy was performed when indicated.
* 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

Interventions

DRUG

Tegoprazan tablet

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

DRUG

Lansoprazole capsules

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

Sponsors & Collaborators

  • Indonesia University

    lead OTHER

Principal Investigators

  • Hasan Maulahela, MD, PhD · Indonesia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-06
Primary Completion
2026-12-31
Completion
2027-02-28

Countries

  • Indonesia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07708545 on ClinicalTrials.gov