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A Study of Crofelemer to Treat Diarrhea Irritable Bowel Syndrome

This study has been completed.
Sponsor:
Information provided by:
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00101725
First received: January 12, 2005
Last updated: November 19, 2010
Last verified: November 2010
  Purpose

This study is designed to evaluate the safety and effectiveness of an investigational drug, TRN-002 (crofelemer) to relieve the symptoms of diarrhea-predominant irritable bowel syndrome (IBS).


Condition Intervention Phase
Irritable Bowel Syndrome
Colonic Diseases
Diarrhea
Gastrointestinal Disease
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)
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)

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.

Secondary Outcome Measures:
  • To assess the efficacy of TRN-002 when administered twice daily for 12 consecutive weeks.

Enrollment: 245
Study Start Date: December 2004
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 125 mg crofelemer Drug: crofelemer
Experimental: 250 mg crofelemer Drug: crofelemer
Experimental: 500 mg crofelemer Drug: crofelemer
Placebo Comparator: placebo Drug: crofelemer

Detailed Description:

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 who are eligible to participate will have a 75% chance of receiving TRN-002 and a 25% chance of receiving placebo (a substance that looks similar to TRN 002 but has no activity). Subjects will not be able to remain on certain standard IBS medications (antidiarrheals) while participating in the study. The total duration is 16 weeks.

The study requires five study visits that include physical exams, ECG and blood draws for laboratory studies. A colon procedure (such as a colonoscopy or flexible sigmoidoscopy) may also be required if it has not been performed since your diagnosis and within the last 5 years. Participants will be asked to make daily entries into a touch-tone telephone diary on a daily basis.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 since your IBS diagnosis and in the past 5 years
  • Willingness to use an approved method of birth control

Exclusion Criteria:

  • Serious medical or surgical conditions
  • Gastrointestinal Cancers, Crohns Disease or Ulcerative Colitis
  • Pregnancy 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: NCT00101725

  Show 29 Study Locations
Sponsors and Collaborators
Salix Pharmaceuticals
  More Information

No publications provided

Responsible Party: Michelle Widmann, Salix Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00101725     History of Changes
Other Study ID Numbers: TRN 002 201
Study First Received: January 12, 2005
Last Updated: November 19, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Salix Pharmaceuticals:
Diarrhea
IBS
Irritable Bowel Syndrome
Abdominal pain

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

ClinicalTrials.gov processed this record on November 20, 2014