NCT00557401已完成2 期
A Multi-Center Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Study of XP19986 in Subjects With Symptomatic Gastroesophageal Reflux Disease (GERD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Number of heartburn events over the treatment period
研究概览
简要总结
To evaluate efficacy and safety of treatment with XP19986 Sustained Release (SR) Tablet compared to placebo in subjects with symptomatic 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)
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
- •History and documentation of GERD diagnosed by a gastroenterologist, with symptoms (heartburn and/or regurgitation) on ≥ 3 days during the week prior to screening and prior to randomization
排除标准
- •Current or historical endoscopic evidence of erosive esophagitis LA Classification Grade B, C, or D
研究组 & 干预措施
XP19986 SR3, 40 mg QD
Experimental
XP19986, 40 mg QD for approximately 32 days
干预措施: XP19986 SR3, 40 mg QD (Drug)
XP19986 SR3, 60 mg QD
Experimental
XP19986, 60 mg QD for approximately 32 days
干预措施: XP19986 SR3, 60 mg QD (Drug)
XP19986 SR3, 30 mg BID
Experimental
XP19986, 30 mg BID for approximately 32 days
干预措施: XP19986 SR3, 30 mg BID (Drug)
Placebo
Placebo Comparator
Placebo for approximately 32 days
干预措施: Placebo (Drug)
XP19986 SR3, 20 mg QD
Experimental
XP19986, 20 mg QD for approximately 32 days
干预措施: XP19986 SR3, 20 mg QD (Drug)
结局指标
主要结局
Number of heartburn events over the treatment period
时间窗: 4-weeks
次要结局
- Frequency of regurgitation; severity of heartburn and regurgitation; sleep symptoms(4-weeks)
研究者
研究点 (1)
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