Diarrhea Predominant Irritable Bowel Syndrome in Females
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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
Full description
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
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
240 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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