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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Irritable Colon; Irritable Bowel Syndrome (IBS)

Treatments: Drug: Alosetron

Study type: Interventional

Funder types: Industry

Identifiers

NCT00067561

S3B30040

Details and patient eligibility

About

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.

Enrollment: 702 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind