A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-range-finding Study of MD-7246 Administered Orally for 12 Weeks to Treat Abdominal Pain in Patients With Diarrhea-predominant Irritable Bowel Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 515
- 试验地点
- 75
- 主要终点
- Change From Baseline in Abdominal Pain at Its Worst on a NRS Through the Treatment Period
研究概览
简要总结
To evaluate the safety and tolerability, treatment effect on abdominal pain, and dose response of MD-7246 administered orally to patients with diarrhea-predominant irritable bowel syndrome (IBS-D).
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
- •Patient meets the Rome IV criteria for diagnosis of IBS-D
- •Patient maintains a minimum level of compliance with daily diary
- •Female patients of childbearing potential must agree to use one of the following methods of birth control:
- •Hormonal contraception
- •Double-barrier method
- •Maintenance of a monogamous relationship with a male partner who has been surgically sterilized by vasectomy
排除标准
- •Patient has clinically significant findings on a physical examination and/or clinical laboratory tests
- •Patient has symptoms of or been diagnosed with a medical condition that may contribute to abdominal pain
- •Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility
- •Patient has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments
- •NOTE: Additional inclusion/exclusion criteria may apply
研究组 & 干预措施
MD-7246 300 μg
1 MD-7246 300-μg oral tablet and 3 matching placebo oral tablets
干预措施: MD-7246 (Drug)
MD-7246 300 μg
1 MD-7246 300-μg oral tablet and 3 matching placebo oral tablets
干预措施: Placebo (Drug)
MD-7246 600 μg
2 MD-7246 300-μg oral tablets and 2 matching placebo oral tablets
干预措施: MD-7246 (Drug)
MD-7246 600 μg
2 MD-7246 300-μg oral tablets and 2 matching placebo oral tablets
干预措施: Placebo (Drug)
MD-7246 1200 μg
4 MD-7246 300-μg oral tablets
干预措施: MD-7246 (Drug)
Placebo
4 matching placebo oral tablets
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Abdominal Pain at Its Worst on a NRS Through the Treatment Period
时间窗: Baseline, up to Week 12 (end of the Treatment Period)
Abdominal pain is measured daily in an eDiary, using an 11-point NRS, where 0 is anchored with "no abdominal pain" and 10 is anchored with "worst possible abdominal pain." The postbaseline weekly abdominal pain score is the average of the non-missing daily abdominal pain at its worst scores during a week (Weeks 1-12) if there are at least 4 daily scores entered into the eDiary during the week. Weekly change from baseline was calculated for each week as the weekly score minus the baseline score. Mixed model repeated measures (MMRM) results are based on a repeated measures analysis with treatment, analysis week, and treatment-by-week interaction as fixed effects and baseline as covariate. An unstructured covariance structure was used to model intra-subject correlation with subjects as a random effect. Baseline is derived from the eDiary data collected daily in the Pretreatment Period, specifically the period of time from 14 days before randomization up to the time of randomization.
Percentage of Participants Who Were 6/12 Week Abdominal Pain 30% Change Responders
时间窗: Baseline through Week 12
A 6/12 Week Abdominal Pain 30% Responder was a participant who had a decrease from baseline of ≥30% in the weekly abdominal pain score for that week for at least 6 out of the 12 weeks of the Treatment Period; for any week, a participant with \< 4 daily abdominal pain scores available was considered a non-responder for that week. Abdominal pain is measured daily in an eDiary, using an 11-point NRS, where 0 is anchored with "no abdominal pain" and 10 is anchored with "worst possible abdominal pain." The postbaseline weekly abdominal pain score is the average of the non-missing daily abdominal pain at its worst scores during a week (Weeks 1-12) if there are at least 4 daily scores entered into the eDiary during the week.
次要结局
未报告次要终点