A Phase 2, Randomized, Double-blind, Placebo-controlled Trial of Fosamprenavir Administered Orally for 8 Weeks in Older Adults With Proton Pump Inhibitor Refractory Gastroesophageal Reflux Disease
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Weekly Heartburn Severity Score
研究概览
简要总结
The goal of this clinical trial is to learn if study drug Fosamprenavir administered orally improves symptoms for Proton Pump Inhibitor (PPI)-refractory Gastro Esophageal Reflux Disease (GERD).
The main questions it aims to answer are:
- Does fosamprenavir significantly improve heartburn severity over the 8-week treatment period
- Does fosamprenavir significantly improve regurgitation frequency over the 8-week treatment period
- Does fosamprenavir significantly improve symptoms of persistent GERD over the 8-week treatment period
Researchers will compare fosamprenavir to a placebo (a look-alike substance that contains no active drug) to see if fosamprenavir works to treat PPI-refractory GERD.
Participants will:
- Take fosamprenavir or placebo every day BID (twice a day) for 8 weeks
- Visit the Adult Translational Research Unit (ATRU) seven times for consenting, screening, and checkups and tests
- Keep a daily diary of their symptoms of persistent GERD
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
We have partnered with Froedtert Hospital's Investigative Drug Services (FH IDS) in order to randomize subjects to either treatment or placebo. Only FH IDS will have the key linking subjects to treatment groups, and the power to conduct an emergency un-blinding.
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 50-65 selected as candidate for anti-reflux surgery by study providers.
- •Patient has received, and continued having GERD symptoms during, standard-labeled dose, daily, PPI therapy for a minimum of 8 weeks before the Screening Visit.
- •Patient has a diagnosis of GERD with endoscopy and/or pH-metry test within the past two years demonstrating 1 or more of the following:
- •Erosive esophagitis (Grade A or greater based on the Los Angeles classification of esophagitis; Appendix 3)
- •Evidence of pathological acid reflux (pH < 4 for ≥ 4-6% off therapy or ≥ 1-4% on therapy) during a 24-hour time interval of pH testing
- •Patient reports heartburn severity (HS, Item #1 on mRESQ-eD) ≥ 3 (moderate) on at least 2 days and has an average HS of ≥ 2 (mild) during the last 7 days of the Pretreatment Period before Randomization.
排除标准
- •Patient is suspected of having, functional upper gastrointestinal disorders such as functional dyspepsia or functional heartburn diagnosed by the Rome IV criteria; Appendix
- •Patient has endoscopically confirmed eosinophilic esophagitis (EE).
研究组 & 干预措施
Oral Placebo
Eight weeks of:
Placebo Pill
干预措施: Placebo (Other)
Oral Fosamprenavir
Eight weeks of:
1400 mg fosamprenavir BID: At least 1 hour before or 2 hours after the morning and evening meals, approximately 12 hours apart
干预措施: Fosamprenavir Calcium 700 MG Oral Tablet (Drug)
结局指标
主要结局
Weekly Heartburn Severity Score
时间窗: Ten days of pre-screening and dailyfor 8 weeks.
Based on questions 1 and 2 of mRESQ-eD. The percent change from baseline (i.e., Pretreatment) in heartburn severity as indicated by Weekly Heartburn Severity Score (WHSS) at Week 8 (end of Treatment Period). Weekly scoring averaged. \[Minimum Value: 0, Maximum Value: 500, higher score= worse outcome\]
Weekly Heartburn Severity Score
时间窗: Baseline to Treatment Week 8 (End of Treatment)
The absolute change from baseline (Pretreatment) in heartburn severity as indicated by Weekly Heartburn Severity Score (WHSS; based on items 1 and 2 of the modified Reflux Symptom Questionnaire Electronic Diary, mRESQ-eD) over time, with the primary treatment comparison at Week 8 (End of Treatment)
次要结局
- Weekly Regurgitation Frequency Score(Ten days of pre-screening and daily for 8 weeks.)
- Daily modified Reflux Symptom Questionnaire Electronic Diary (mRESQ-eD)(Ten days of pre-screening and daily for 8 weeks.)
- Weekly Regurgitation Frequency Score(Baseline to Treatment Week 8 (End of Treatment))
- Weekly Heartburn-free Days(Baseline to Treatment Week 8 (End of Treatment))
- Weekly Overall Reflux Symptom-free Days(Baseline to Treatment Week 8 (End of Treatment))
研究者
Nikki Johnston
Professor
Medical College of Wisconsin