A Study of YM060 in Diarrhea-predominant Irritable Bowel Syndrome (d-IBS)

A Randomized, Double-blind, Placebo-controlled Study to Investigate the Potential Efficacy, Safety and Tolerability of Different Oral Doses of YM060 in Patients With Diarrhea-predominant Irritable Bowel Syndrome

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00189813

Enrollment

691

Registered

2005-09-19

Start date

2005-03-31

Completion date

2005-12-31

Last updated

2014-08-28

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

Conditions

Irritable Bowel Syndrome

Keywords

Irritable Bowel Syndrome, Diarrhea, Nasea®, Irribow®, ramosetron

Brief summary

This study will examine the efficacy, safety and tolerability of different oral dose of YM060, 5-HT3 receptor antagonist, in patients with d-IBS.

Interventions

DRUGYM060

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Patient meets Rome II criteria for IBS and the subgroup of diarrhea predominant IBS

Exclusion criteria

* Patient with severe cardiovascular disease, respiratory diseases, renal diseases, hepatic diseases, digestive tract diseases (excluding IBS), blood diseases, or neurological or psychiatric diseases * Patient reported having any Type 1 or Type 2 stool on the Bristol Stool Form Scale during the run-in period

Countries

Bulgaria, Czechia, Estonia, Germany, Lithuania, Poland, Russia, Ukraine

Outcome results

None listed

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