Potassium Competitive Acid Blocker (PCAB) Test-Guided vs Physiologic Test-Guided Treatment in Patients With Typical Reflux Symptoms: A Randomized Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Proportion of Participants with Clinical Response to Treatment
研究概览
简要总结
The goal of this clinical trial is to learn if a short course of a potassium-competitive acid blocker (PCAB) test can guide treatment of adults with typical reflux symptoms as effectively as standard physiologic testing with endoscopy and 24-hour pH-impedance monitoring. It will also learn about the safety of PCAB-guided management.
The main questions it aims to answer are:
- Is PCAB test-guided treatment as effective as physiologic test-guided treatment in improving reflux symptoms after 4 weeks?
- How accurate is the PCAB test at detecting pathologic acid reflux compared with 24-hour pH-impedance monitoring?
- What medical problems do participants have when receiving PCAB-, proton-pump inhibitor-, or neuromodulator-based treatment?
- In this study, researchers will compare two strategies: one group will receive a 7-day course of vonoprazan (PCAB) as a diagnostic test and then treatment guided by the PCAB response, while the other group will undergo endoscopy and 24-hour pH-impedance monitoring with treatment guided by those results.
Participants will:
- Be randomly assigned to either the PCAB test-guided group or the physiologic test-guided group
- Take study medicines by mouth (such as vonoprazan, omeprazole, and/or nortriptyline or matching placebos) for about 4 weeks, depending on their test results and symptom type
- Attend scheduled clinic visits for checkups, questionnaires, and safety monitoring
- Keep a diary of their reflux symptoms, quality of life, and any use of rescue antacid medicine
详细描述
This protocol describes a single-center, randomized, controlled, open-label, parallel-group, non-inferiority trial comparing a potassium-competitive acid blocker (PCAB) test-guided strategy with physiologic test-guided management in adults with typical reflux symptoms suggestive of gastroesophageal reflux disease (GERD).
The study will enroll approximately 120 participants aged 18-70 years with heartburn, regurgitation, or non-cardiac chest pain, and will exclude patients with Barrett's esophagus, peptic ulcer, prior upper GI surgery, significant comorbidities, or recent use of potent anti-secretory, neuromodulator, or prokinetic agents.
Participants are randomized in a 1:1 ratio to either a 7-day vonoprazan-based PCAB test or to a reference strategy using esophagogastroduodenoscopy (EGD) plus 24-hour pH-impedance monitoring and high-resolution manometry in accordance with Lyon Consensus 2.0 and Rome IV criteria.
The primary objective is to determine whether PCAB test-guided treatment is non-inferior to physiologic test-guided treatment with respect to clinical response, defined by improvement in reflux symptoms after 4 weeks of allocated therapy.
Secondary objectives include: (1) assessment of the diagnostic performance of the PCAB test for pathologic acid reflux using 24-hour pH-impedance monitoring as the reference standard; (2) comparison of changes in Reflux Disease Questionnaire (RDQ) scores, Likert symptom scales for heartburn, regurgitation and chest pain, EQ-5D quality-of-life scores, symptom-free days, rescue antaciduse, and patient satisfaction; and (3) evaluation of treatment-emergent adverse events andserious adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 70 years.
- •Presence of specific gastroesophageal reflux disease (GERD) symptoms, including heartburn, regurgitation, and/or esophageal chest pain, occurring at least 4 times per week for more than 4 weeks prior to enrollment.
排除标准
- •Presence of GERD complications, including esophageal stricture and/or Barrett's esophagus.
- •Concomitant symptoms that may interfere with GERD treatment, such as frequent belching or rumination syndrome.
- •History of gastric or duodenal ulcers.
- •History of upper gastrointestinal surgery (involving the esophagus, stomach, or small intestine).
- •Use of any of the following medications within 4 weeks prior to enrollment: aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), mucoprotective agents, prokinetics, or neuromodulators.
- •Use of proton pump inhibitors (PPIs), histamine H2-receptor antagonists (H2RAs), or potassium-competitive acid blockers (PCABs) within 2 weeks prior to enrollment. (Note: Patients may become eligible if they complete a minimum 2-week washout period).
- •Any contraindications for ambulatory esophageal reflux monitoring.
- •Known history of hypersensitivity, allergy, or adverse reactions to the study medications: vonoprazan, omeprazole, or nortriptyline.
- •Pregnant or breastfeeding women.
结局指标
主要结局
Proportion of Participants with Clinical Response to Treatment
时间窗: 4 weeks
To compare the proportion of participants with typical gastroesophageal reflux disease (GERD) symptoms who achieve a clinical response to treatment. This will be compared between the group receiving treatment guided by the PCAB (Potassium-Competitive Acid Blocker) test and the group receiving treatment guided by physiological testing.
次要结局
- Diagnostic Performance of the PCAB Test for Pathologic Acid Reflux(Baseline)
- Change in GERD Symptom Severity (Likert Scale)(Baseline and at 4 weeks)
- Change in Reflux Disease Questionnaire (RDQ) Score(Baseline and at 4 weeks)
- Percentage of Symptom-Free Days(Up to 4 weeks)
- Frequency of Rescue Antacid Use(Up to 4 weeks)
- Change in Quality of Life (EQ-5D)(Baseline and at 4 weeks)
- Proportion of Participants Satisfied With the Assigned Treatment Protocol at Week 4(At 4 weeks)
- Rate of Study Withdrawal Due to Severe Symptoms(Up to 4 weeks)
- Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(Up to 4 weeks)
- Participant Satisfaction With the Diagnostic Testing Method Assessed Using a Study-Specific 5-Point Likert Scale(Immediately after completion of diagnostic testing on Day 0)
- Prevalence of GERD Phenotypes(Baseline)