Second Phase 3 Randomized, 12-Week, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Plecanatide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,135
- 试验地点
- 2
- 主要终点
- Number of Overall Responders - ITT Population
研究概览
简要总结
This study in patients with IBS-C is a randomized, double-blind, placebo-controlled, parallel-group clinical trial with 12 weeks of study drug therapy.
详细描述
This study in patients with IBS-C is a randomized, double-blind, placebo-controlled, parallel-group clinical trial with 12 weeks of study drug therapy.
Screening/Baseline: Patients will undergo an up to 28-day Screening/Baseline period to allow for any necessary diagnostic procedures, allow for required washout of medications and to determine study eligibility. If otherwise eligible based on screening criteria, patients will undergo a 2-week baseline assessment using an electronic diary where they will record daily assessments of bowel movements (BMs), stool consistency (Bristol Stool Form Scale-BSFS), abdominal pain and other IBS-related symptoms. Data from the two-week electronic diary assessment just prior to the randomization visit will be used to confirm IBS-C and study eligibility as well as define the patient's baseline from which change will be determined.
Treatment: Patients who meet all entry criteria will be randomized (1:1:1) to one of three blinded treatment groups on Day 1 of the Treatment period. Patients will take an oral dose of study drug OD for 12 weeks and continue the daily electronic diaries (BMs, rescue medication use, abdominal pain, and other symptoms). During treatment weeks 4, 8, and 12, patients will return to the clinic to undergo safety and efficacy assessments.
Post-Treatment: For 2 weeks after completing dosing, patients will continue to complete daily electronic diaries. Patients will then return to the clinical site for a final follow-up visit during Week 14 following randomization.
The planned duration of participation in this study will be at least 116 days from signing of informed consent through post-treatment or up to approximately 135 days with 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients between the ages of 18 and 85 years (inclusive) with a diagnosis of IBS based on ROME III diagnostic criteria and meeting criteria for diagnosis of the constipation predominant subtype - IBS-C
排除标准
- •Refusal or inability to sign informed consent for the trial
- •Refusal or inability to complete daily Episodic (real-time) BM / RM calls, End of Day daily Calls, and/or complete electronic questionnaires
- •BMI ≥ 40 or < 18
- •Women of child bearing potential who refuse to use an acceptable method of birth control for the duration of the trial
- •Women who are pregnant or lactating
- •Diagnosis of IBS-D or IBS-M
- •Organic or obstructive disease of the small or large intestine
- •Use of laxatives other than the study-supplied rescue medication (Dulcolax®, bisacodyl)
- •Use of a prohibited concomitant medication within the time frame prior to screening outlined in the study protocol for that medication
- •Unstable medical illness
- •Bilirubin > 3X ULN in the absence of a conjugation defect
- •Any laboratory value > 3X ULN unless discussed and approved by the study Medical Monitor
研究组 & 干预措施
3.0 mg plecanatide
Plecanatide 3.0 mg dosed daily for 12 weeks
干预措施: Plecanatide (Drug)
6.0 mg plecanatide
Plecanatide 6.0 mg dosed daily for 12 weeks
干预措施: Plecanatide (Drug)
Matching placebo
Placebo dosed daily for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Overall Responders - ITT Population
时间窗: 12 weeks
An Overall Responder was a patient who was a weekly responder (i.e., decrease of 30% from baseline for abdominal pain intensity and an increase of at least 1 complete spontaneous bowel movement in the same week) for at least 6 of the 12 treatment weeks.
Number of Abdominal Pain Responders for at Least 6 of 12 Treatment Weeks
时间窗: 12 Weeks
An Abdominal Pain Intensity Responder was a patient who had a decrease of 30 % from baseline for abdominal pain intensity. Baseline is the mean of non-missing abdominal pain scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug.
Number of Stool Frequency Responder for at Least 6 of the 12 Treatment Weeks
时间窗: 12 Weeks
A Stool Frequency Responder was a patient who experienced an increase of at least one CSBM (complete spontaneous bowel movement) per week from baseline. Baseline was the mean number of CSBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug.
次要结局
- Change From Baseline in Straining(Baseline and 12-Week)
- Change From Baseline in CSBMs (CSBMs/Week)Complete Spontaneous Bowel Movement(Baseline and 12-Week)
- Number of Patients With a SBM Within 24 Hours After First Dose of Study Medication(Up to 24 hours after the first dose of study drug)
- Change From Baseline in Abdominal Pain(Baseline and 12-Week)
- Number of Sustained Efficacy Responders(12 Weeks)
- Change From Baseline in Stool Consistency(Baseline and 12-Week)