NCT01472939已完成2 期
A Phase 2b, Double-blind, Randomized, Placebo-controlled, Dose-finding Study to Evaluate Efficacy of a Selective 5-HT4 Receptor Agonist and Proton Pump Inhibitor (PPI) in Subjects With Gastroesophageal Reflux Disease (GERD) With Persistent Regurgitation With or Without Heartburn
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 480
- 试验地点
- 82
- 主要终点
- Change From Baseline in Percent Regurgitation-Free Days Over Weeks 5-8
研究概览
简要总结
The aim of this study is to establish a dose-related effect of a selective 5-HT4 receptor agonist compared to placebo on residual symptoms (regurgitation with or without heartburn) in subjects with GERD who have persistent symptoms while on PPI therapy.
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, Investigator)
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
- 否
入选标准
- •Written Informed Consent Form signed voluntarily before the first study-related activity.
- •Aged between 18 and 70 years, inclusive.
- •Subjects with a history of the cardinal symptoms of GERD (both heartburn and regurgitation) prior to PPI therapy.
- •Subjects with symptoms of GERD for at least 6 months prior to the Screening Visit.
- •Subjects who have persistent symptoms of regurgitation for 3 or more days over the past week with or without heartburn while on PPI.
- •Subjects have at least some improvement to the symptom of heartburn while on PPI therapy.
- •Subjects on PPI therapy for at least 8 weeks prior to the Screening Visit of which the last 4 weeks are on a stable labeled dose for any GERD indication according to the country label, where a change of PPI therapy would not impact the symptoms (twice-daily dosing of PPI is not allowed in the last 4 weeks)
排除标准
- •Subjects who show no response to heartburn while on PPI therapy.
- •Subjects with dyspepsia symptoms that are more predominant than their GERD symptoms (heartburn and/or regurgitation).
- •Subjects with prior endoscopic anti-reflux procedure or major GI surgery or subjects with major GI disorders.
- •Presence of severe and clinically uncontrolled cardiovascular, liver, lung or neurologic disease, cancer or AIDS.
- •Alarm symptoms suggestive of malignancies or organic disease.
研究组 & 干预措施
SSP-002358 (0.1 mg) + Proton Pump Inhibitor (PPI)
Active Comparator
干预措施: SSP-002358 (0.1 mg) + PPI (Drug)
SSP-002358 (0.5 mg) + PPI
Active Comparator
干预措施: SSP-002358 (0.5 mg) + PPI (Drug)
SSP-002358 (2.0 mg) + PPI
Active Comparator
干预措施: SSP-002358 (2.0 mg) + PPI (Drug)
Placebo + PPI
Placebo Comparator
干预措施: Placebo + PPI (Drug)
结局指标
主要结局
Change From Baseline in Percent Regurgitation-Free Days Over Weeks 5-8
时间窗: Baseline and over weeks 5-8
次要结局
- Change From Baseline in Heartburn-Free Days Over Weeks 5-8(Baseline and over weeks 5-8)
- Change From Baseline in the Persistent Reflux Integrated Symptom Measurement (PRISM) Liquid and Food Domain Scores Over Weeks 5-8(Baseline and over weeks 5-8)
- Area Under the Steady-state Plasma Concentration-time Curve (AUC) of SSP-002358(Over 8 hours post-dose (week 2 or later))
- Steady State Maximum Plasma Concentration (Cmax) of SSP-002358(Over 8 hours post-dose (week 2 or later))
- Time to Maximum Plasma Concentration (Tmax) of SSP-002358(Over 8 hours post-dose (week 2 or later))
研究者
研究点 (82)
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