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Tegoprazan Versus Lansoprazole for Endoscopic Ulcer Healing in Bleeding Peptic Ulcers

RecruitingPhase 2

Sponsor: Indonesia University

Conditions: Peptic Ulcer Bleeding

Interventions: Tegoprazan tablet, Lansoprazole capsules

Countries: Indonesia

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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:

  1. . Fluid resuscitation and blood transfusion, if necessary,
  2. . High-dose PPI therapy for 72 hours,
  3. . Gastroscopy within 24 hours of hospital admission and endoscopic hemostatic therapy, if necessary,
  4. . Lansoprazole 30 mg or tegoprazan 50 mg therapy for 14 days,
  5. . Treatment for H. pylori infection if positive,
  6. . Repeat gastroscopy after 14 days of treatment to assess the progress of therapy.

Exclusion Criteria:

* 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.

Locations (3)

Tangerang, Banten, Indonesia
Jakarta Pusat, DKI Jakarta, Indonesia
Padang, West Sumatra, Indonesia