Overview

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

Status:
Completed
Trial end date:
2005-12-01
Target enrollment:
0
Participant gender:
Female
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
GlaxoSmithKline
Treatments:
Alosetron
Criteria
Inclusion Criteria:

- Diagnosed with severe diarrhea-predominant Irritable Bowel Syndrome (IBS).

- Failed conventional therapy.

- Willing to make daily calls on a touch-tone telephone.

Exclusion criteria:

- 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.