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โ† Trials
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Tegoprazan Versus Lansoprazole for Endoscopic Ulcer Healing in Bleeding Peptic Ulcers

RecruitingPhase 2Ages 18 Years - anyAllUniversitas Indonesia
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In plain words

What the trial is, and whether it could suit you

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 t

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๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Tegoprazan tablet
  • Lansoprazole capsules
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Where

3 sites
RSUD Balaraja
Tangerang, Indonesia
RSUPN Dr. Cipto Mangunkusumo
Jakarta Pusat, Indonesia
RSUP Dr. M. Djamil
Padang, Indonesia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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