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

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Astellas

Status and phase

Completed
Phase 2

Conditions

Irritable Bowel Syndrome

Treatments

Drug: YM060
Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01274000
060-CL-701

Details and patient eligibility

About

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.

Enrollment

409 patients

Sex

Female

Ages

20 to 64 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

409 participants in 4 patient groups, including a placebo group

placebo group
Placebo Comparator group
Treatment:
Drug: placebo
YM060 low-dose group
Experimental group
Treatment:
Drug: YM060
YM060 middle-dose group
Experimental group
Treatment:
Drug: YM060
YM060 high-dose group
Experimental group
Treatment:
Drug: YM060

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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