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A Study of Crofelemer to Treat Diarrhea Irritable Bowel Syndrome

Primary Purpose

Irritable Bowel Syndrome, Colonic Diseases, Diarrhea

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
crofelemer
Sponsored by
Bausch Health Americas, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Diarrhea, IBS, Irritable Bowel Syndrome, Abdominal pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Research Associates
  • Radiant Research Phoenix Southeast
  • Arkansas Gastroenterology
  • AGMG Clinical Research Institute
  • Community Clinical Trials
  • AGMG Clinical Research
  • Institute of Healthcare Assessment, Inc.
  • Washington Gastroenterology
  • Consultants for Clinical Research of South Florida
  • University Clinical Research DeLand
  • nTouch Research
  • Synergy Medical Education Alliance
  • CRC of Jakson
  • Mercy Medical Group
  • Tobey Village Office Park
  • LeBauer Research Associates, PA
  • Medoff Medical / Vital Research
  • Hanover Medical Specialists, PA
  • Piedmont Medical Research Assoc., Inc.
  • Consultants for Clinical Research
  • Radient Research
  • Grandview Medical Research, Inc
  • Anderson Gastroenterology
  • TriCities Medical Research
  • ClinSearch
  • Jackson Clinic
  • Memphis Gastroenterology
  • Radiant Research Dallas-North
  • Tacoma Digestive Disease Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

125 mg crofelemer

250 mg crofelemer

500 mg crofelemer

placebo

Arm Description

Outcomes

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.

Full Information

First Posted
January 12, 2005
Last Updated
November 21, 2019
Sponsor
Bausch Health Americas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00101725
Brief Title
A Study of Crofelemer to Treat Diarrhea Irritable Bowel Syndrome
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)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
November 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bausch Health Americas, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome, Colonic Diseases, Diarrhea, Gastrointestinal Disease
Keywords
Diarrhea, IBS, Irritable Bowel Syndrome, Abdominal pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
245 (Actual)

8. Arms, Groups, and Interventions

Arm Title
125 mg crofelemer
Arm Type
Experimental
Arm Title
250 mg crofelemer
Arm Type
Experimental
Arm Title
500 mg crofelemer
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
crofelemer
Primary Outcome Measure Information:
Title
To assess the safety of TRN-002 when administered twice daily for 12 consecutive weeks.
Secondary Outcome Measure Information:
Title
To assess the efficacy of TRN-002 when administered twice daily for 12 consecutive weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Clinical Research Associates
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Radiant Research Phoenix Southeast
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85225
Country
United States
Facility Name
Arkansas Gastroenterology
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Facility Name
AGMG Clinical Research Institute
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Community Clinical Trials
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
AGMG Clinical Research
City
Orange
State/Province
California
ZIP/Postal Code
92869
Country
United States
Facility Name
Institute of Healthcare Assessment, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Washington Gastroenterology
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Consultants for Clinical Research of South Florida
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Facility Name
University Clinical Research DeLand
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
nTouch Research
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
Synergy Medical Education Alliance
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48602
Country
United States
Facility Name
CRC of Jakson
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Mercy Medical Group
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Tobey Village Office Park
City
Pittsford
State/Province
New York
ZIP/Postal Code
14534
Country
United States
Facility Name
LeBauer Research Associates, PA
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
Medoff Medical / Vital Research
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Hanover Medical Specialists, PA
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Piedmont Medical Research Assoc., Inc.
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Consultants for Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Radient Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Grandview Medical Research, Inc
City
Sellersville
State/Province
Pennsylvania
ZIP/Postal Code
18960
Country
United States
Facility Name
Anderson Gastroenterology
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
TriCities Medical Research
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
ClinSearch
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Jackson Clinic
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38301
Country
United States
Facility Name
Memphis Gastroenterology
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Radiant Research Dallas-North
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Tacoma Digestive Disease Research Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Study of Crofelemer to Treat Diarrhea Irritable Bowel Syndrome

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