NCT00730665终止2 期
A Parallel-Group, Randomized, Double-Blind, Multi-Center Dose Response Study To Evaluate The Efficacy And Safety Of PF-00885706, A 5-HT4 Receptor Partial Agonist, As Add-On Therapy To Esomeprazole For The Relief Of Symptoms In Subjects With Gastro-esophageal Reflux Disease (GERD) Who Have A Poor Response To Proton Pump Inhibitor (PPI) Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Complete resolution of heartburn and regurgitation. [i.e. no more than one day with either mild heartburn or regurgitation over the seven days prior to the assessment time-point (Visit 6 and Visit 8)]
研究概览
简要总结
To understand the dose-response characteristics of PF-00885706 for efficacy in terms of symptomatic relief when used as add-on treatment to esomeprazole 20mg (standard proton pump inhibitor [PPI] treatment), in subjects with gastro-esophageal reflux (GERD) who have inadequate relief with PPIs.
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
- Triple (Participant, 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
- •Subjects with a diagnosis of GERD who fulfill the following criteria:
- •who have symptoms for least six months prior to enrollment; who are currently on daily treatment with a PPI and have been on such treatment for at least 3 months; whose symptoms are persistent, troublesome and that include heartburn and/or regurgitation as their predominant symptoms despite treatment with a PPI; who are seeking relief of persistent symptoms.
排除标准
- •Subjects with erosive esophagitis - An endoscopy within the last 5 years is required to verify absence.
- •Subjects with any esophageal or gastric diseases/conditions that may contribute to their GERD symptoms.
- •If female; pregnant, lactating or positive serum or urine pregnancy tests.
研究组 & 干预措施
100ug
Experimental
干预措施: PF-00885706 (Drug)
100ug
Experimental
干预措施: Esomeprazole (Drug)
300ug
Experimental
干预措施: PF-00885706 (Drug)
300ug
Experimental
干预措施: Esomeprazole (Drug)
1mg
Experimental
干预措施: PF-00885706 (Drug)
1mg
Experimental
干预措施: Esomeprazole (Drug)
3mg
Experimental
干预措施: PF-00885706 (Drug)
3mg
Experimental
干预措施: Esomeprazole (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
Placebo
Placebo Comparator
干预措施: Esomeprazole (Drug)
结局指标
主要结局
Complete resolution of heartburn and regurgitation. [i.e. no more than one day with either mild heartburn or regurgitation over the seven days prior to the assessment time-point (Visit 6 and Visit 8)]
时间窗: 28 days
次要结局
- Number of days with heartburn (daytime and night-time)(28 days)
- Number of days with regurgitation (daytime and night-time)(28 days)
- Number of heartburn and regurgitation-free days (24hrs)(28 days)
- Composite score of heartburn and regurgitation frequency and severity(28 days)
- Time to resolution of symptoms of heartburn/regurgitation(28 days)
- Number of antacid rescue medication (Gaviscon) tablets used(28 days)
- Severity of additional GERD symptoms(28 days)
- Quality of Life (assessed using PAGI-QOL to PGIC (Patient Global Impression of Change)(28 days)
- Complete resolution of heartburn(28 days)
- Complete resolution of regurgitation(28 days)
- Average severity of heartburn (daytime and night-time)(28 days)
- Average severity of regurgitation (daytime and night-time)(28 days)
研究者
研究点 (1)
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