Diarrhea Predominant Irritable Bowel Syndrome in Females

This study has been completed.
Sponsor:
Information provided by:
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00461526
First received: November 9, 2006
Last updated: November 19, 2010
Last verified: November 2010
  Purpose

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

Condition Intervention Phase
Irritable Bowel Syndrome
Drug: crofelemer
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Salix Pharmaceuticals:

Primary Outcome Measures:
  • To assess the safety of TRN-002 when administered twice daily for 12 consecutive weeks. [ Time Frame: March 2008 ] [ Designated as safety issue: Yes ]
  • To assess the efficacy of TRN-002 when administered twice daily for 12 consecutive weeks. [ Time Frame: March 2008 ] [ Designated as safety issue: Yes ]

Enrollment: 240
Study Start Date: October 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 125 mg crofelemer Drug: crofelemer
125 mg crofelemer vs. placebo
Placebo Comparator: placebo Drug: crofelemer
125 mg crofelemer vs. placebo

Detailed 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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00461526

  Show 43 Study Locations
Sponsors and Collaborators
Salix Pharmaceuticals
  More Information

No publications provided

Responsible Party: Michelle Widmann, Associate Director, Clinical Operations, Salix Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00461526     History of Changes
Other Study ID Numbers: TRN-002-202
Study First Received: November 9, 2006
Last Updated: November 19, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Salix Pharmaceuticals:
IBS
d-IBS
Irritable Bowel Syndrome

Additional relevant MeSH terms:
Diarrhea
Irritable Bowel Syndrome
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 23, 2014