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

Completed · Phase 3

Conditions studied: Irritable Colon, Irritable Bowel Syndrome (IBS)

In brief

The purpose of this study is to compare the safety and effectiveness of as needed versus fixed dosing of an investigational medication for women with severe diarrhea-predominant Irritable Bowel Syndrome (IBS) who have failed conventional therapy.

Key facts

Study ID

NCT00067457

Run by

GlaxoSmithKline

People needed

700

Starts

2003-06-01

Expected to finish

2005-12-01

Last updated by the study team

2015-04-16

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with severe diarrhea-predominant Irritable Bowel Syndrome (IBS).
• Failed conventional therapy.
• Willing to make daily calls on a touch-tone telephone.

You may not qualify if…

• History of or current chronic or severe constipation.
• Bloody diarrhea, abdominal pain with rectal bleeding.
• Thrombophlebitis.
• Abnormal thyroid stimulating hormone (TSH) value.
• Alcohol and/or substance abuse within past two years.
• Pregnant or lactating.
• History/treatment of malignancy within past five years.

Where it is running

• GSK Investigational Site — Birmingham, Alabama, United States
• GSK Investigational Site — Huntsville, Alabama, United States
• GSK Investigational Site — Mobile, Alabama, United States
• GSK Investigational Site — Pell City, Alabama, United States
• GSK Investigational Site — Tallassee, Alabama, United States
• GSK Investigational Site — Tucson, Arizona, United States
• GSK Investigational Site — Little Rock, Arkansas, United States
• GSK Investigational Site — North Little Rock, Arkansas, United States
• GSK Investigational Site — Beverly Hills, California, United States
• GSK Investigational Site — Carlsbad, California, United States
• GSK Investigational Site — Concord, California, United States
• GSK Investigational Site — Encinitas, California, United States
• GSK Investigational Site — Fresno, California, United States
• GSK Investigational Site — Garden Grove, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Orange, California, United States
• GSK Investigational Site — Roseville, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — San Francisco, California, United States
• GSK Investigational Site — San Francisco, California, United States
• GSK Investigational Site — San Francisco, California, United States
• GSK Investigational Site — Santa Ana, California, United States
• GSK Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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