A Study to Evaluate Efficacy of YM060 on Diarrhea-predominant Irritable Bowel Syndrome (D-IBS) in Female Patients

Phase II Study of YM060 - Double-blind, Parallel-group Comparative Study in Patients (Female) With Diarrhea-predominant Irritable Bowel Syndrome

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01274000

Enrollment

409

Registered

2011-01-11

Start date

2010-11-30

Completion date

2011-10-31

Last updated

2015-10-12

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

Conditions

Irritable Bowel Syndrome

Keywords

diarrhea, IBS, Colonic disease, YM060, Ramosetron

Brief summary

A study to verify the superiority of YM060 (ramosetron) to placebo for female patients with diarrhea-predominant irritable bowel syndrome (D-IBS) and to evaluate its safety.

Interventions

DRUGYM060

oral

DRUGplacebo

oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 64 Years

Healthy volunteers

Inclusion criteria

* Patients meeting the Rome III Diagnostic Criteria * Loose (mushy) or watery stools within the last 3 months * Abdominal discomfort and/or pain during their non-menstrual period

Exclusion criteria

* Patients with a history of surgical resection of the stomach, small intestine or large intestine * Patients with a history or current diagnosis of inflammatory bowel disease (Crohn's disease or colitis ulcerative) * Patients with a history or current diagnosis of colitis ischemic * Patients with a current diagnosis of enteritis infectious * Patients with a current diagnosis of hyperthyroidism or hypothyroidism * Patients who are currently participating in another clinical trial (including a post-marketing clinical study) or those who participated in another clinical trial (including a post-marketing clinical study) within 12 weeks before the study * Patients with a history or current diagnosis of malignant tumor * Patients with a history of abuse of drugs or alcohol within 1 year or those who are currently abusing them

Design outcomes

Primary

Measure	Time frame
Responder rate of patients reported global assessment of relief of IBS symptoms	for 4 weeks

Secondary

Measure	Time frame
Responder rate of patients reported assessment of relief of abdominal discomfort and/or pain	for 4 weeks
Responder rate of patients reported assessment of improvement of abnormal bowel habits	for 4 weeks
Change in weekly average scores of stool form (appearance)	Baseline and for 4 weeks
Safety assessed by the incidence of adverse events and abnormal values in lab-tests	for 4 weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026