Actively Recruiting
Evaluating the Efficacy of Vonoprazan in Preventing Post-Endoscopic Variceal Band Ligation Ulcers: A Randomized Controlled Trial
Led by King Edward Medical University · Updated on 2025-12-26
154
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether the medicine vonoprazan can help prevent ulcers that sometimes develop after endoscopic variceal band ligation (EVBL) in adults with liver cirrhosis. The study also aims to find out if vonoprazan is well tolerated and if it reduces swallowing pain or chest discomfort compared with a placebo. This is a Phase 2 randomized controlled trial led by King Edward Medical University. Participants will be randomly assigned to receive either vonoprazan 20 mg or a placebo tablet once daily for 14 days following EVBL. Vonoprazan works by strongly suppressing gastric acid, which may help prevent ulcers and improve symptoms after the procedure. Both groups will continue their usual medical care for liver disease, and the study is double-blinded, meaning neither participants nor doctors know which treatment is given until after data analysis. During the study, participants will take the assigned medication by mouth daily and return about two weeks later for a follow-up endoscopy to check for ulcers. They will also report symptoms such as pain, nausea, or swallowing difficulties throughout the study. Researchers will measure the number and severity of ulcers, changes in pain scores, and monitor safety and tolerability. The study is expected to last about six months.
CONDITIONS
Brief Title
Evaluating the Efficacy of Vonoprazan in Preventing Post-Endoscopic Variceal Band Ligation Ulcers: A Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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, or Glasgow Coma Scale less than 10
- Active gastrointestinal bleeding at the time of enrollment
- Malignancy of the upper gastrointestinal tract
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 14 days
Participants receive vonoprazan 20 mg or placebo orally once daily for 14 days following endoscopic variceal band ligation (EVBL) to prevent post-procedural ulcers and reduce symptoms.
1 baseline visit and 1 follow-up visit at approximately 14 days after EVBL
Trial Site Locations
Total: 1 location
1
King Edward Medical University/Mayo Hospital
Lahore, Punjab Province, Pakistan, 54000
Actively Recruiting
Research Team
M
Muhammad R Tariq, MBBS,FCPS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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