A Dose-Response Efficacy and Safety Study of Arbaclofen Placarbil (XP19986) as Adjunctive Therapy in Subjects With Gastroesophageal Reflux Disease (GERD) Who Are Incomplete Responders to a Proton Pump Inhibitor (PPI)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 460
- 主要终点
- Heartburn Episodes
研究概览
简要总结
The purpose of the study is to evaluate efficacy and safety of arbaclofen placarbil (XP19986) versus placebo as adjunctive therapy in subjects with troublesome GERD symptoms despite therapy with approved doses of a Proton Pump Inhibitor (PPI).
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)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •confirmed diagnosis of GERD by a gastroenterologist
- •minimum of 3 months of GERD symptoms prior to screening.
- •currently taking an FDA approved dose of PPI therapy for symptomatic GERD for at least 4 weeks prior to screening
- •experienced partial relief of GERD symptoms while receiving approved dose and regimen of PPI therapy
- •experienced GERD symptoms, defined as heartburn (with or without regurgitation or other GERD symptoms) on ≥ 3 days during the week prior to screening
排除标准
- •evidence of erosive esophagitis or erosive gastritis on upper gastrointestinal endoscopy during screening
- •has not experienced any GERD symptom improvement after an adequate course of PPI treatment (at least 2 weeks)
- •unstable or severe medical condition
研究组 & 干预措施
arbaclofen placarbil-Cohort 1
arbaclofen placarbil 20 mg QD with PPI*
* Allowable PPIs : Rabeprazole Sodium 20 mg QD, Esomeprazole Magnesium 20 mg or 40 mg QD, Lansoprazole 15 mg or 30 mg QD, Pantoprazole 20 mg or 40 mg QD, Omeprazole 20 mg or 40 mg QD, Omeprazole/sodium bicarbonate 20 mg or 40 mg QD, Dexlansoprazole 30 mg or 60 mg QD
干预措施: arbaclofen placarbil-Cohort 1 (Drug)
arbaclofen placarbil-Cohort 1
arbaclofen placarbil 20 mg QD with PPI*
* Allowable PPIs : Rabeprazole Sodium 20 mg QD, Esomeprazole Magnesium 20 mg or 40 mg QD, Lansoprazole 15 mg or 30 mg QD, Pantoprazole 20 mg or 40 mg QD, Omeprazole 20 mg or 40 mg QD, Omeprazole/sodium bicarbonate 20 mg or 40 mg QD, Dexlansoprazole 30 mg or 60 mg QD
干预措施: PPI (Drug)
arbaclofen placarbil-Cohort 2
arbaclofen placarbil 40 mg QD with PPI*
* Allowable PPIs : Rabeprazole Sodium 20 mg QD, Esomeprazole Magnesium 20 mg or 40 mg QD, Lansoprazole 15 mg or 30 mg QD, Pantoprazole 20 mg or 40 mg QD, Omeprazole 20 mg or 40 mg QD, Omeprazole/sodium bicarbonate 20 mg or 40 mg QD, Dexlansoprazole 30 mg or 60 mg QD
干预措施: arbaclofen placarbil-Cohort 2 (Drug)
arbaclofen placarbil-Cohort 2
arbaclofen placarbil 40 mg QD with PPI*
* Allowable PPIs : Rabeprazole Sodium 20 mg QD, Esomeprazole Magnesium 20 mg or 40 mg QD, Lansoprazole 15 mg or 30 mg QD, Pantoprazole 20 mg or 40 mg QD, Omeprazole 20 mg or 40 mg QD, Omeprazole/sodium bicarbonate 20 mg or 40 mg QD, Dexlansoprazole 30 mg or 60 mg QD
干预措施: PPI (Drug)
arbaclofen placarbil-Cohort 3
arbaclofen placarbil 20 mg BID with PPI*
* Allowable PPIs : Rabeprazole Sodium 20 mg QD, Esomeprazole Magnesium 20 mg or 40 mg QD, Lansoprazole 15 mg or 30 mg QD, Pantoprazole 20 mg or 40 mg QD, Omeprazole 20 mg or 40 mg QD, Omeprazole/sodium bicarbonate 20 mg or 40 mg QD, Dexlansoprazole 30 mg or 60 mg QD
干预措施: arbaclofen placarbil-Cohort 3 (Drug)
arbaclofen placarbil-Cohort 3
arbaclofen placarbil 20 mg BID with PPI*
* Allowable PPIs : Rabeprazole Sodium 20 mg QD, Esomeprazole Magnesium 20 mg or 40 mg QD, Lansoprazole 15 mg or 30 mg QD, Pantoprazole 20 mg or 40 mg QD, Omeprazole 20 mg or 40 mg QD, Omeprazole/sodium bicarbonate 20 mg or 40 mg QD, Dexlansoprazole 30 mg or 60 mg QD
干预措施: PPI (Drug)
arbaclofen placarbil-Cohort 4
arbaclofen placarbil 30 mg BID with PPI*
* Allowable PPIs : Rabeprazole Sodium 20 mg QD, Esomeprazole Magnesium 20 mg or 40 mg QD, Lansoprazole 15 mg or 30 mg QD, Pantoprazole 20 mg or 40 mg QD, Omeprazole 20 mg or 40 mg QD, Omeprazole/sodium bicarbonate 20 mg or 40 mg QD, Dexlansoprazole 30 mg or 60 mg QD
干预措施: arbaclofen placarbil-Cohort 4 (Drug)
arbaclofen placarbil-Cohort 4
arbaclofen placarbil 30 mg BID with PPI*
* Allowable PPIs : Rabeprazole Sodium 20 mg QD, Esomeprazole Magnesium 20 mg or 40 mg QD, Lansoprazole 15 mg or 30 mg QD, Pantoprazole 20 mg or 40 mg QD, Omeprazole 20 mg or 40 mg QD, Omeprazole/sodium bicarbonate 20 mg or 40 mg QD, Dexlansoprazole 30 mg or 60 mg QD
干预措施: PPI (Drug)
Placebo-Cohort 5
Placebo dose with PPI*
* Allowable PPIs : Rabeprazole Sodium 20 mg QD, Esomeprazole Magnesium 20 mg or 40 mg QD, Lansoprazole 15 mg or 30 mg QD, Pantoprazole 20 mg or 40 mg QD, Omeprazole 20 mg or 40 mg QD, Omeprazole/sodium bicarbonate 20 mg or 40 mg QD, Dexlansoprazole 30 mg or 60 mg QD
干预措施: Placebo-Cohort 5 (Drug)
Placebo-Cohort 5
Placebo dose with PPI*
* Allowable PPIs : Rabeprazole Sodium 20 mg QD, Esomeprazole Magnesium 20 mg or 40 mg QD, Lansoprazole 15 mg or 30 mg QD, Pantoprazole 20 mg or 40 mg QD, Omeprazole 20 mg or 40 mg QD, Omeprazole/sodium bicarbonate 20 mg or 40 mg QD, Dexlansoprazole 30 mg or 60 mg QD
干预措施: PPI (Drug)
结局指标
主要结局
Heartburn Episodes
时间窗: 6 weeks
number of episodes
次要结局
- Regurgitation Episodes(6 weeks)