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

NCT07267260 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2025-12-26

No results posted yet for this study

Summary

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 mouth once daily for 14 days after EVBL.

Return for a follow-up endoscopy about two weeks later to check for ulcers.

Report any symptoms such as pain, nausea, or swallowing difficulty during the study.

Adults aged 18 to 75 years with liver cirrhosis who undergo EVBL will be invited to join. Participants will be randomly assigned to one of two groups, and neither they nor the study doctors will know which treatment they receive (double-blind design).

The study will take place at Mayo Hospital, Lahore, Pakistan, over about six months.

By comparing vonoprazan to placebo, researchers hope to find a better way to protect the esophagus and stomach after EVBL, reduce post-procedure pain, and support faster recovery in people with liver cirrhosis.

Conditions

  • Cirrhoses, Liver

Interventions

DRUG

Vonoprazan 20 mg

Vonoprazan is a potassium-competitive acid blocker (P-CAB) that provides strong and sustained suppression of gastric acid secretion. In this study, participants will receive vonoprazan 20 mg by mouth once daily for 14 days after endoscopic variceal band ligation (EVBL). The tablets will be taken with water, preferably before breakfast. This dose and duration are based on prior clinical experience in acid-related disorders. The aim is to determine whether vonoprazan prevents the formation of ulcers and reduces post-procedure pain compared with placebo.

OTHER

Placebo

Participants in the placebo group will receive a look-alike oral tablet with no active medicine, once daily for 14 days after EVBL. The placebo will be identical in color, size, and packaging to the Vonoprazan tablet to maintain blinding. This comparator will help determine whether Vonoprazan provides any true benefit in preventing ulcers and improving symptoms beyond standard post-procedure care.

Sponsors & Collaborators

  • King Edward Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-16
Primary Completion
2026-01-30
Completion
2026-03-05

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07267260 on ClinicalTrials.gov