diarrhea predominant irritable bowel syndrome in females

Conditions: Irritable Bowel Syndrome

Summary: 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

Eligibility criteria:
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

Keywords: ibs d-ibs irritable bowel syndrome