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NCT00101725 · ClinicalTrials.gov registry record · Phase 2

A Study of Crofelemer to Treat Diarrhea Irritable Bowel Syndrome

A Phase 2 study of Irritable Bowel Syndrome and Diarrhea, sponsored by Bausch Health Americas.

Completed
Registry status
Phase 2
Development phase
245
Enrollment target
20
Study locations

NCT00101725 is a Phase 2 study of Irritable Bowel Syndrome and Diarrhea that has completed, run by Bausch Health Americas. The registered enrollment target is 245 participants, above the 139-participant average among 47 other Irritable Bowel Syndrome trials with a reported enrollment target (76% higher). The trial reports 20 study locations across 13 states.

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The verdict

NCT00101725, a Phase 2 study of Irritable Bowel Syndrome and Diarrhea, has completed, sponsored by Bausch Health Americas.

COMPLETED
Registry status
Phase 2
Development phase
245 participants
Enrollment target
20
Study locations

Study 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).

Conditions Studied

Irritable Bowel Syndrome Diarrhea Gastrointestinal Disease Colonic Diseases

Interventions

  • DRUG crofelemer

Study Locations (20)

California

  • AGMG Clinical Research Institute - Anaheim
  • Community Clinical Trials - Orange
  • AGMG Clinical Research - Orange
  • Institute of Healthcare Assessment, Inc. - San Diego

North Carolina

  • LeBauer Research Associates, PA - Greensboro
  • Medoff Medical / Vital Research - Greensboro
  • Hanover Medical Specialists, PA - Wilmington
  • Piedmont Medical Research Assoc., Inc. - Winston-Salem

Florida

  • Consultants for Clinical Research of South Florida - Boynton Beach
  • University Clinical Research DeLand - DeLand

Alabama

  • Clinical Research Associates - Huntsville

Arizona

  • Radiant Research Phoenix Southeast - Chandler

Arkansas

  • Arkansas Gastroenterology - North Little Rock

District of Columbia

  • Washington Gastroenterology - Washington D.C.

Illinois

  • nTouch Research - Peoria

Trial Details

FieldValue
Enrollment Target 245 participants
Start Date 2004-12
Est. Completion 2005-11
Phase Phase 2

Sponsor

Bausch Health Americas

168 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00101725

The ClinicalTrials.gov registry entry for NCT00101725 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 245 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 139-participant average among 47 other Irritable Bowel Syndrome trials with a reported enrollment target (76% higher). The listed sponsor is Bausch Health Americas, which has 168 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Irritable Bowel Syndrome appearing as the primary indexed condition, and to 1 intervention - of which crofelemer is the first listed.

NCT00101725 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, North Carolina, Florida.

Frequently Asked Questions

What is clinical trial NCT00101725 about?

NCT00101725 is a clinical study titled "A Study of Crofelemer to Treat Diarrhea Irritable Bowel Syndrome". 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).

What is the current status of trial NCT00101725?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 245 participants. The study started on 2004-12. Estimated completion is 2005-11.

What conditions does trial NCT00101725 study?

This clinical trial studies the following conditions: Irritable Bowel Syndrome, Diarrhea, Gastrointestinal Disease, Colonic Diseases.

What interventions are being tested in trial NCT00101725?

The interventions under investigation include: crofelemer (DRUG).

Who is sponsoring clinical trial NCT00101725?

This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00101725 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.