Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bausch Health Americas, Inc.
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
Serious medical or surgical conditions
Gastrointestinal Cancers, Crohns Disease or Ulcerative Colitis
Pregnancy or breast feeding
Clareo Health | A Study of Crofelemer to Treat Diarrhea Irritable Bowel Syndrome
