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) in Females

Trial Information

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) in Females

Clinical Trial with TRN-002 in Women with Irritable Bowel Syndrome (IBS)

The purpose of this study is to investigate the safety and effectiveness of a new
investigational drug in women for the treatment of diarrhea-predominant irritable bowel
syndrome. 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 will
be not able to remain on certain standard IBS medications (anti-diarrheals) while
participating in the study. The total duration of the study is 18 weeks.

The study requires five study visits that include physical exams, ECG, blood draws,
laboratory studies, and a colon procedure (such as a colonoscopy or flexible sigmoidoscopy
if an appropriate procedure has not been performed in the last 5 years.) Participants will
be asked to make entries into a touch-tone telephone diary on a daily basis.

Participants must meet all of the following criteria:

- Females at least 18 years of age

- 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 in the past 5 years.

- Willingness to take an approved method of birth control (if required)

Participants CANNOT meet any of the following criteria:

- Serious medical or surgical conditions

- Colon Cancer, Crohns Disease or Ulcerative Colitis

- Pregnant or breast feeding