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NCT00067561 · ClinicalTrials.gov registry record · Phase 3

Study Of Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional Therapy

A Phase 3 study of Irritable Bowel Syndrome (IBS) and Irritable Colon, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 3
Development phase
702
Enrollment target
20
Study locations

NCT00067561 is a Phase 3 study of Irritable Bowel Syndrome (IBS) and Irritable Colon that has completed, run by GlaxoSmithKline. The registered enrollment target is 702 participants, below the 1,048-participant average among 5 other Irritable Bowel Syndrome (IBS) trials with a reported enrollment target (33% lower). The trial reports 20 study locations across 4 states.

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The verdict

NCT00067561, a Phase 3 study of Irritable Bowel Syndrome (IBS) and Irritable Colon, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 3
Development phase
702 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to compare the safety and effectiveness of different doses of an investigational medication in women with severe diarrhea-predominant Irritable Bowel Syndrome (IBS) who have failed conventional therapy.

Conditions Studied

Irritable Bowel Syndrome (IBS) Irritable Colon

Interventions

  • DRUG Alosetron

Study Locations (20)

California

  • GSK Investigational Site - Chula Vista
  • GSK Investigational Site - Fountain Valley
  • GSK Investigational Site - Garden Grove
  • GSK Investigational Site - Lancaster
  • GSK Investigational Site - Los Angeles
  • GSK Investigational Site - Newport Beach
  • GSK Investigational Site - Rancho Cucamonga
  • GSK Investigational Site - Redlands
  • GSK Investigational Site - San Diego
  • GSK Investigational Site - San Diego
  • GSK Investigational Site - San Rafael
  • GSK Investigational Site - Santa Ana
  • GSK Investigational Site - Santa Ana
  • GSK Investigational Site - Upland

Alabama

  • GSK Investigational Site - Birmingham
  • GSK Investigational Site - Calera
  • GSK Investigational Site - Tuscaloosa

Arizona

  • GSK Investigational Site - Phoenix
  • GSK Investigational Site - Tucson

Arkansas

  • GSK Investigational Site - Fayetteville

Trial Details

FieldValue
Enrollment Target 702 participants
Start Date 2003-06
Est. Completion 2005-01
Phase Phase 3

Sponsor

GlaxoSmithKline

1,345 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00067561

The ClinicalTrials.gov registry entry for NCT00067561 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 702 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,048-participant average among 5 other Irritable Bowel Syndrome (IBS) trials with a reported enrollment target (33% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Irritable Bowel Syndrome (IBS) appearing as the primary indexed condition, and to 1 intervention - of which Alosetron is the first listed.

NCT00067561 reports 20 study locations spanning 4 distinct geographic areas - top geographies include California, Alabama, Arizona.

Frequently Asked Questions

What is clinical trial NCT00067561 about?

NCT00067561 is a clinical study titled "Study Of Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional Therapy". The purpose of this study is to compare the safety and effectiveness of different doses of an investigational medication in women with severe diarrhea-predominant Irritable Bowel Syndrome (IBS) who have failed conventional therapy.

What is the current status of trial NCT00067561?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 702 participants. The study started on 2003-06. Estimated completion is 2005-01.

What conditions does trial NCT00067561 study?

This clinical trial studies the following conditions: Irritable Bowel Syndrome (IBS), Irritable Colon.

What interventions are being tested in trial NCT00067561?

The interventions under investigation include: Alosetron (DRUG).

Who is sponsoring clinical trial NCT00067561?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00067561 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California. 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.