A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of RDX5791 for the Treatment of Constipation-Predominant Irritable Bowel Syndrome (IBS-C)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Ardelyx
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- Complete Spontaneous Bowel Movement (CSBM) Frequency Change From Baseline
研究概览
简要总结
This is a multi-center, Phase 2, randomized, double-blind, placebo controlled study of RDX5791 in subjects with IBS-C. Patients who are 18 to 75 years old, meeting the definition of IBS-C as defined by the Rome III Criteria for the Diagnosis of IBS will undergo a battery of screening procedures to determine eligibility for the trial.
The study will consist of a 2-week treatment-free screening period, a 4-week blinded treatment period, and a 2-week treatment-free follow-up period.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject meets Rome III criteria for IBS-C
- •If > 50 years old, colonoscopy evaluation within 10 years
- •All ages, negative colonoscopy if any "warning symptoms"
- •Active disease during 2-week screening period
- •Compliant with IVRS
排除标准
- •Subjects has IBS-D, IBS-M or un-subtyped IBS according to Rome III criteria
- •Diagnosis or treatment of any clinically symptomatic biochemical or structural abnormality of the GI tract
- •Use of medications that are known to affect stool consistency
- •Subject has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments or prevent completion of study
研究组 & 干预措施
Placebo
Capsule that is identical in size and color to other treatments
干预措施: RDX5791 (Drug)
Low Dose
10 mg capsule of tenapanor
干预措施: RDX5791 (Drug)
Mid Dose
30 mg capsule of tenapanor
干预措施: RDX5791 (Drug)
High Dose
100 mg capsule of tenapanor
干预措施: RDX5791 (Drug)
结局指标
主要结局
Complete Spontaneous Bowel Movement (CSBM) Frequency Change From Baseline
时间窗: Baseline and Week 4
Patients complete a phone diary daily. They are asked "how many bowel movements have you had today?" they are then asked for each spontaneous bowel movement (unaided with laxative use) wether there was its was a complete evacuation. if it was then it is a complete spontaneous bowel movement. All CSBMs are added and adjusted for a mean compete sponteneous bowel movement.
次要结局
- Spontaneous Bowel Movement (SBM) Frequency Change From Baseline(baseline and week 4)