A National, Randomized, 12-Week, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Plecanatide (3.0 and 6.0 mg) in Patients With Chronic Idiopathic Constipation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,410
- 试验地点
- 1
- 主要终点
- Number of Durable Overall CSBM Responders, Mean Replacement Approach
研究概览
简要总结
The purpose of this study is to confirm that the investigational medication, plecanatide, is safe and effective in treating chronic idiopathic constipation.
详细描述
This is a national, randomized, 12-week, double-blind, placebo-controlled, study in approximately 1350 adult male and female patients with CIC comparing 2 doses of plecanatide to placebo. The study will be conducted at approximately 180 clinical study sites in the United States. The primary objective of the study is to evaluate the efficacy and safety of 3.0 and 6.0 mg of plecanatide administered once daily (QD) for 12 weeks in a population of patients with CIC. The study population will include only patients without other causes of constipation or other chronic conditions that could interfere with study assessments. Patients may not take laxatives (with the exception of the study-provided rescue medication, bisacodyl 5mg tablets), or a number of prohibited drugs that are known to cause constipation or diarrhea, during study participation.
There are 6 scheduled study visits, including the screening and follow-up visits. The planned duration of participation in this study will be 112 days and up to 155 days, with washout and all visit windows considered.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18-80, inclusive
- •Meets modified Rome III criteria for functional chronic idiopathic constipation for at least 3 months with symptom onset for at least 6 months
- •Completed a colonoscopy in accordance with American Gastroenterological Association (AGA) colon cancer screening guidelines (5 years), with no clinically significant findings
- •Willing to maintain a stable diet during the study
排除标准
- •Loose stool (mushy) or watery (Bristol score 6 or 7) stool in the absence of any laxative or prohibited medicine for > 25% of Bowel Movements (BMs) during the 3 months prior to screening visit OR during the 14 day pre-treatment assessment
- •Active peptic ulcer disease, diabetes or hypertension not adequately treated or not stable
- •History of cathartic colon, laxative, enema abuse, or ischemic colitis
- •Fecal impaction within 3 months of screening
- •Patient has had /has any: diseases or conditions associated with constipation (GI or CNS), structural abnormality of the GI tract or gastric bypass surgery, pelvic floor dysfunction, pseudo-obstruction, active infectious gastritis, diverticulitis, anal fissures or any disease or condition that can affect GI motility or defecation or can be associated with abdominal pain
- •Unexplained and clinically significant "alarm symptoms" including lower GI bleeding, iron-deficiency anemia, weight loss or systemic signs of infection or colitis
- •Major surgery, stroke or myocardial infarction (MI) within 60 days of screening
- •Participated in a previous plecanatide clinical trial
研究组 & 干预措施
Plecanatide 3.0 mg
Plecanatide tablets 3.0 mg QD for 12 weeks
干预措施: Plecanatide (Drug)
Placebo
Matching placebo tablets QD for 12 weeks
干预措施: Placebo (Drug)
Plecanatide 6.0 mg
Plecanatide tablets 6.0 mg QD for 12 weeks
干预措施: Plecanatide (Drug)
结局指标
主要结局
Number of Durable Overall CSBM Responders, Mean Replacement Approach
时间窗: 12-Week Treatment Period
The primary efficacy endpoint was measured by the number of durable overall CSBM responders over the 12-week Treatment Period. A durable overall CSBM responder was defined as a weekly CSBM responder for at least 9 of the 12 treatment weeks, including at least 3 of the last 4 weeks. A CSBM weekly responder was defined as a patient who has ≥ 3 Complete Spontaneous Bowel Movements (CSBMs) per week and an increase from baseline of ≥1 CSBM for that week. A CSBM was a bowel movement that occurred in the absence of laxative use within 24 hours and was associated with the feeling of complete evacuation.
次要结局
- Change From Baseline in CSBMs (CSBMs/Week) Over the 12-week Treatment Period , Mean Replacement Approach(Baseline and 12 weeks)
- Change From Baseline in Average Weekly SBM Stool Consistency Over the 12-week Treatment Period, Mean Replacement Approach(Baseline and 12 weeks)
- Change From Baseline in Average Weekly Straining Score Over the 12-week Treatment Period, Mean Replacement Approach(Baseline and 12 weeks)
- Change From Baseline in SBMs (SBMs/Week) Over the 12-week Treatment Period, Mean Replacement Approach(Baseline and 12 weeks)