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Phase 3 Study of YM060 in Patients With Diarrhea-predominant Irritable Bowel Syndrome (d-IBS)

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Astellas

Status and phase

Completed
Phase 3

Conditions

Irritable Bowel Syndrome

Treatments

Drug: YM060

Study type

Interventional

Funder types

Industry

Identifiers

NCT00189696
060-CL-202

Details and patient eligibility

About

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

Sex

All

Ages

20 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients satisfying the Rome II Diagnostic Criteria.
  • Patients in whom no organic changes were observed in large intestine.

Exclusion criteria

  • Patients have diseases which interfere with evaluation of the efficacy and safety in this study.
  • Patients are receiving and/or have received prior to the enrollment the treatment which interfere with evaluation of the efficacy and safety in this study.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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