A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of TRN 002 (Crofelemer) for the Symptomatic Treatment of Diarrhea-Predominant Irritable Bowel Syndrome (d-IBS)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 245
- 试验地点
- 29
- 主要终点
- To assess the safety of TRN-002 when administered twice daily for 12 consecutive weeks.
研究概览
简要总结
This study is designed to evaluate the safety and effectiveness of an investigational drug, TRN-002 (crofelemer) to relieve the symptoms of diarrhea-predominant irritable bowel syndrome (IBS).
详细描述
The investigational drug is a natural product taken from a plant that grows in South America. The study medication will be administered orally twice a day. Subjects who are eligible to participate will have a 75% chance of receiving TRN-002 and a 25% chance of receiving placebo (a substance that looks similar to TRN 002 but has no activity). Subjects will not be able to remain on certain standard IBS medications (antidiarrheals) while participating in the study. The total duration is 16 weeks.
The study requires five study visits that include physical exams, ECG and blood draws for laboratory studies. A colon procedure (such as a colonoscopy or flexible sigmoidoscopy) may also be required if it has not been performed since your diagnosis and within the last 5 years. Participants will be asked to make daily entries into a touch-tone telephone diary on a daily basis.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of diarrhea predominant Irritable Bowel Syndrome
- •Willingness to make daily calls on a touch-tone telephone
- •Willingness to have an endoscopic and/or radiologic bowel evaluation, if you have not received one since your IBS diagnosis and in the past 5 years
- •Willingness to use an approved method of birth control
排除标准
- •Serious medical or surgical conditions
- •Gastrointestinal Cancers, Crohns Disease or Ulcerative Colitis
- •Pregnancy or breast feeding
研究组 & 干预措施
500 mg crofelemer
干预措施: crofelemer (Drug)
125 mg crofelemer
干预措施: crofelemer (Drug)
250 mg crofelemer
干预措施: crofelemer (Drug)
placebo
干预措施: crofelemer (Drug)
结局指标
主要结局
To assess the safety of TRN-002 when administered twice daily for 12 consecutive weeks.
次要结局
- To assess the efficacy of TRN-002 when administered twice daily for 12 consecutive weeks.