Evaluating the Efficacy of Vonoprazan in Preventing Post-Endoscopic Variceal Band Ligation Ulcers: A Randomized Controlled Trial
报名条件(概要)
- 年龄:18 Years – 75 Years
- 性别:不限
- 健康志愿者:不接受
完整入排标准请以官方页面为准。
开展国家/地区
Pakistan
药品与企业信息
其他名称:Potassium-competitive acid blocker、TAK-438
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.
其他名称:Inactive tablet
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.
研发企业
试验官方登记的主要申办方;研究机构申办时会显示相应机构名称。
生产企业
公开药品批准资料或正式说明书暂未提供明确的生产企业信息。
研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业;生产企业仅取自美国上市原研药说明书所列企业(不含仿制药),不作推测;仅在其他国家上市的药品暂无法显示。
研究简介(原文)
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.
适应症
主动联系研究团队
这项试验目前在中国大陆没有研究中心
这种情况下,直接发"入组咨询"往往会被回复"您所在地区没有中心"。更有效的做法是申请同情用药/扩展准入(由主治医生一同提出),或询问能否到最近的境外中心参加。下面已为您切换到对应的信件版本。
查看完整申请路径与成功率说明 →总联系人(申办方/研究总部)
- Muhammad R Tariq, MBBS,FCPSibneislam190@gmail.com+923337692728
研究中心联系方式
- King Edward Medical University/Mayo HospitalLahore,Punjab Province,Pakistan
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英文版(发给研究团队)
Dear Study Team, I am a patient in China and I am interested in participating in your clinical trial: Study Title: Evaluating the Efficacy of Vonoprazan in Preventing Post-Endoscopic Variceal Band Ligation Ulcers: A Randomized Controlled Trial ClinicalTrials.gov Identifier: NCT07267260 Sponsor: King Edward Medical University Investigational product: Vonoprazan 20 mg, Placebo About me: - Age: (please fill in) - Sex: (please fill in) - Confirmed diagnosis and stage: (please fill in) - Biomarkers / genetic testing: not available - Prior and current treatments: (please fill in) - Performance status (ECOG): not assessed - Current location: China - Travel ability: (please fill in) Could you please let me know: 1. Whether I might be eligible for this study; 2. Which site would be closest and most practical for me, and whether remote pre-screening is possible; 3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening. I can provide English translations of my medical records. Thank you very much for your time and help. Kind regards, (your name) (your email / phone with country code)
中文对照(供您核对)
尊敬的研究团队: 我是一位来自中国的患者,希望咨询参加以下临床试验的可能: 研究名称:Evaluating the Efficacy of Vonoprazan in Preventing Post-Endoscopic Variceal Band Ligation Ulcers: A Randomized Controlled Trial 试验编号:NCT07267260 申办方:King Edward Medical University 研究药物:Vonoprazan 20 mg、Placebo 我的基本情况: - 年龄:(请填写) - 性别:(请填写) - 确诊疾病与分期:(请填写) - 基因/标志物检测:暂无 - 既往及当前治疗:(请填写) - 体能状态(ECOG):未评估 - 目前所在城市:中国 - 可前往范围:(请填写) 想请教三个问题: 1. 我是否可能符合本研究的入组标准? 2. 哪个中心对我最方便可行?能否远程预筛? 3. 预筛需要准备哪些资料(病历、病理、影像、近期化验)? 我可以提供英文翻译版病历。感谢您的时间与帮助。 顺祝安康 (您的姓名) (您的邮箱/带国际区号的电话)
提示:请与主治医生一起发信——由医生署名的申请,回复率远高于患者单独发信。首封邮件不要附身份证号等敏感信息。研究团队通常在 3–10 个工作日内回复,两周无回音可礼貌追问一次。
下一步怎么做?
- 把本页信息带给您的主治医生,评估是否适合参加。
- 点击下方按钮打开官方注册页,查看研究中心联系方式。
- 直接联系研究团队咨询报名事宜(通常有中文同声翻译服务可协助沟通)。