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Evaluating the Efficacy of Vonoprazan in Preventing Post-Endoscopic Variceal Band Ligation Ulcers: A Randomized Controlled Trial

RecruitingPhase 2Ages 18 Years - 75 YearsAllKing Edward Medical University
NCT07267260 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to learn if the medicine vonoprazan can help prevent ulcers that may develop after endoscopic variceal band ligation (EVBL) in adults with liver cirrhosis. These ulcers sometimes cause pain or delayed bleeding after the procedure. The study will also look at how well vonoprazan is tolerated and if it improves comfort after the procedure. The main questions this study will answer are: Does vonoprazan lower the number and severity of ulcers found on endoscopy after EVBL? Does vonoprazan reduce swallowing pain or chest discomfort compared with placebo? Is vonoprazan safe and well tolerated in people with liver cirrhosis? Researchers will compare vonoprazan 20 mg once daily with a placebo (a look-alike tablet that contains no active medicine) to see if vonoprazan works better to prevent these ulcers. Participants will: Take vonoprazan or placebo by

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adults aged 18 to 75 years (male or female) * Diagnosis of liver cirrhosis confirmed by clinical, biochemical, or imaging findings. * Presence of documented esophageal varices requiring endoscopic variceal band ligation (EVBL). * Able and willing to provide written informed consent in English or Urdu. * Willing to comply with study procedures, including taking study medication and attending follow-up endoscopy. Exclusion Criteria: * History of gastric or esophageal surgery * Allergy or contraindication to vonoprazan or study drug components * Pregnant or lactating women * Individuals who are non-cooperative or unable to understand local languages * Critically ill patients, including: ICU admission Requirement for mechanical ventilation GCS \< 10 * Active gastrointestinal bleeding at the time of enrollment * Malignancy of the upper gastrointestinal tract
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What it tests

  • Vonoprazan 20 mg
  • Placebo
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Where

1 site
King Edward Medical University/Mayo Hospital
Lahore, Pakistan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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