A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Trial of Oral IW-3718 Administered to Patients With Gastroesophageal Reflux Disease While Receiving Proton Pump Inhibitors
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 495
- 试验地点
- 99
- 主要终点
- Change From Baseline in WHSS at Week 8
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy of IW-3718 administered to patients with GERD who continue to have persistent symptoms, such as heartburn and regurgitation, while receiving once-daily (QD), standard-dose 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Each patient must meet all of the following criteria to be eligible for enrollment in this study:
- •Patient is an ambulatory male or female (if female, nonpregnant) and is at least 18 years old at the Screening Visit.
- •Patient has a diagnosis of GERD and reports experiencing GERD symptoms (heartburn or regurgitation) while taking standard PPI therapy.
- •Patient has evidence of pathological acid reflux.
- •Female patients must not be pregnant and must agree to avoid pregnancy for the duration of the study.
- •Patient must comply with study procedures.
排除标准
- •Patients who meet any of the following criteria will not be eligible to participate in the study:
- •Patient has a history of complete lack of GERD symptom response to PPI therapy.
- •Patient has a significant medical or surgical history including conditions that would impact drug absorption or metabolism (such as bowel obstruction, poorly controlled diabetes, gastroparesis, hiatal hernia).
- •Patient reports pain or burning behind the breastbone or in the center of the upper stomach as his or her predominant symptom at the Screening Visit.
- •Patient has received an investigational drug during the 30 days before the Screening Visit, or is planning to receive another investigational drug or use an investigational device at any time during the study.
- •NOTE: Other inclusion and exclusion criteria apply, per the study protocol.
研究组 & 干预措施
1500 mg IW-3718 BID + PPI
Three 500 mg IW-3718 tablets administered twice daily (BID), immediately after the morning and evening meals. Standard-dose PPIs administered QD approximately 30-60 minutes before the morning meal each day.
干预措施: IW-3718 (Drug)
1500 mg IW-3718 BID + PPI
Three 500 mg IW-3718 tablets administered twice daily (BID), immediately after the morning and evening meals. Standard-dose PPIs administered QD approximately 30-60 minutes before the morning meal each day.
干预措施: Standard-dose PPIs QD (Drug)
Placebo + PPI
Three placebo tablets administered BID immediately after the morning and evening meals. Standard-dose PPIs administered QD approximately 30-60 minutes before the morning meal each day.
干预措施: placebo (Drug)
Placebo + PPI
Three placebo tablets administered BID immediately after the morning and evening meals. Standard-dose PPIs administered QD approximately 30-60 minutes before the morning meal each day.
干预措施: Standard-dose PPIs QD (Drug)
结局指标
主要结局
Change From Baseline in WHSS at Week 8
时间窗: Baseline, Week 8
The WHSS is defined as the weekly average of the DHSS. The DHSS for a day is the greater of the 2 items assessing heartburn severity (Item #1 "Burning feeling behind the breastbone or in the center of the upper stomach" and Item #2 "Pain behind the breastbone or in the center of the upper stomach"). The DHSS items are assessed on a 5-point ordinal scale, where 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, and 5=Severe; higher scores indicate worse symptoms. A negative change from baseline indicates improvement.
次要结局
- Percentage of Participants Who Were Overall Heartburn Responders During the 8-Week Treatment Period(Up to Week 8)
- Change From Baseline in Weekly Regurgitation Frequency Score (WRFS) at Week 8(Baseline, Week 8)
- Proportion of Heartburn-Free Days During the 8-Week Treatment Period(Up to Week 8)