Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 12:27 AM
Study NCT ID:
NCT07267260
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-05
First Post:
2025-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Efficacy of Vonoprazan in Preventing Post-Endoscopic Variceal Band Ligation Ulcers: A Randomized Controlled Trial
Sponsor:
King Edward Medical University
Organization:
Study Overview
Official Title:
Evaluating the Efficacy of Vonoprazan in Preventing Post-Endoscopic Variceal Band Ligation Ulcers: A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 640/RC/KEMU | OTHER | IRB King Edward Medical University | View |