Diarrhea Predominant Irritable Bowel Syndrome in Females

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

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

Inclusion 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) Exclusion Criteria: Serious medical or surgical conditions Colon Cancer, Crohns Disease or Ulcerative Colitis Pregnant or breast feeding

Nee J, Salley K, Ludwig AG, Sommers T, Ballou S, Takazawa E, Duehren S, Singh P, Iturrino J, Katon J, Lee HN, Rangan V, Lembo AJ. Randomized Clinical Trial: Crofelemer Treatment in Women With Diarrhea-Predominant Irritable Bowel Syndrome. Clin Transl Gastroenterol. 2019 Dec;10(12):e00110. doi: 10.14309/ctg.0000000000000110.