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

A 12-Week, Randomized, Double-Blind, Placebo- Controlled Study of PRN BID and Fixed Dosing Regimens of Alosetron in Female Subjects With Severe Diarrhea-Predominant Irritable Bowel Syndrome Who Have Failed Conventional Therapy

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00067457

Enrollment

700

Registered

2003-08-21

Start date

2003-06-30

Completion date

2005-12-31

Last updated

2015-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome (IBS), Irritable Colon

Keywords

PRN, Diarrhea-Predominant Irritable Bowel Syndrome, Irritable Bowel Syndrome (IBS)

Brief 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.

Interventions

DRUGalosetron

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Subject self assessment of improvement between treatment groups using the IBS Global Improvement Scale; comparison of safety and tolerability between treatment groups with respect to adverse events & laboratory abnormalities.	12 Weeks

Secondary

Measure	Time frame
Comparison of treatment groups with respect to subject relief of IBS pain & discomfort; lower GI symptoms, changes in quality of life, lost workplace productivity, & lost household/leisure activity, & subject satisfaction with assigned study drug.	12 Weeks

Countries

Australia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026