Diarrhea Predominant Irritable Bowel Syndrome in Females

Official Title: “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

Intervention(s) in this Clinical Trial

• Drug: crofelemer
  • 125 mg crofelemer vs. placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 125 mg crofelemer
• Placebo Comparator: placebo

Primary Measures

• To assess the safety of TRN-002 when administered twice daily for 12 consecutive weeks.
  • Time Frame: March 2008
    Safety Issue?: Yes
• To assess the efficacy of TRN-002 when administered twice daily for 12 consecutive weeks.
  • Time Frame: March 2008
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Salix Pharmaceuticals Industry

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00461526

Study ID Number: TRN-002-202

ClinicalTrials.gov Identifier: NCT00461526

Health Authority: United States: Food and Drug Administration