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.