NCT07267260 Evaluating the Efficacy of Vonoprazan in Preventing Post-Endoscopic Variceal Band Ligation Ulcers: A Randomized Controlled Trial
| NCT ID | NCT07267260 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | King Edward Medical University |
| Condition | Cirrhoses, Liver |
| Study Type | INTERVENTIONAL |
| Enrollment | 154 participants |
| Start Date | 2025-12-16 |
| Primary Completion | 2026-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 154 participants in total. It began in 2025-12-16 with a primary completion date of 2026-01-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07267260 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Cirrhoses, Liver. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07267260 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07267260 currently recruiting?
Yes, NCT07267260 is actively recruiting participants. Contact the research team at ibneislam190@gmail.com for enrollment information.
Where is the NCT07267260 trial being conducted?
This trial is being conducted at Lahore, Pakistan.
Who is sponsoring the NCT07267260 clinical trial?
NCT07267260 is sponsored by King Edward Medical University. The trial plans to enroll 154 participants.