Tegoprazan vs Lansoprazole for Healing Bleeding Peptic Ulcers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 randomized trial compares tegoprazan to lansoprazole for healing bleeding peptic ulcers. Eligible adults with upper GI bleeding receive initial stabilization, high-dose acid suppression, and gastroscopy with possible endoscopic therapy, followed by daily dosing of either tegoprazan or lansoprazole for 14 days. The primary goal is to determine which drug achieves better ulcer healing after two weeks. Endpoints include endoscopic healing at 14 days and safety in this patient population. Study sites include hospitals in Jakarta, Tangerang, and Padang under Universitas Indonesia leadership.

Why it matters

Who can join: the full rules

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.

Where it's running

• RSUD Balaraja
  Tangerang, Banten, Indonesia Recruiting
• RSUPN Dr. Cipto Mangunkusumo
  Jakarta Pusat, DKI Jakarta, Indonesia Recruiting
• RSUP Dr. M. Djamil
  Padang, West Sumatra, Indonesia Recruiting

Study contacts

• Principal investigator: Hasan Maulahela, MD, PhD — Universitas Indonesia
• Study coordinator: dr. Hasan Maulahela, Sp.PD-KGEH, MD, PhD
• Email: aspendrhasanmaulahela@gmail.com
• Phone: +6281283602549

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.