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

A Twelve-Week, Randomized, Double Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of 0.5 mg QD, 1 mg QD and 1 mg BID of Alosetron in Female Subjects With Severe Diarrhea-predominant IBS Who Have Failed Conventional Therapy

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00067561

Enrollment

702

Registered

2003-08-25

Start date

2003-06-30

Completion date

2005-01-31

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

Dose-ranging, Diarrhea-Predominant Irritable Bowel Syndrome, d-IBS, IBS, Irritable Bowel Syndrome

Brief summary

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.

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.	—

Secondary

Measure	Time frame
Comparison of treatment groups with respect to subject relief of IBS pain & discomfort.	—

Countries

Australia, United States

Outcome results

None listed

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