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CompletedNCT00918411Updated Oct 12, 2015

A Preliminary Study to Explore Clinical Endpoints in Patients (Male) With Diarrhea-predominant Irritable Bowel Syndrome

A Phase 4 interventional study of Ramosetron and Placebo in Irritable Bowel Syndrome, sponsored by Astellas Pharma Inc. Completed at 4 sites in Japan. Open to male participants aged 20 Years to 64 Years. Per ClinicalTrials.gov, last updated 2015-10-12.

Sponsored by Astellas Pharma Inc · Phase 4 and Interventional

Phase
Phase 4
Study type
Interventional
Enrollment
98
Allocation
Randomized
Ages
20 Years to 64 Years
Sex
Male
01

Study summary

The purpose of this study is to explore and examine endpoints that allow evaluation of the "clinically significant improvements, focusing on the patient's chief complaint and the severity of major IBS symptoms" by this drug in patients with diarrhea-predominant irritable bowel syndrome (IBS).

02

Conditions studied

  • Irritable Bowel Syndrome

Keywords

  • diarrhea
  • IBS
  • Colonic diseases
  • YM060
03

In context

Irritable Bowel Syndrome

1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.

This study's enrollment of 98 is above the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.

Browse Irritable Bowel Syndrome studies →

Lead sponsor

Astellas Pharma Inc is the lead sponsor of 512 studies on the registry; 4 are open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 19 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 64 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • Patients meeting the Rome III Diagnostic Criteria
  • Loose (mushy) or watery stools within the last 3 months

Exclusion criteria

Exclusion Criteria:

  • Patients having hyperthyroidism or hypothyroidism
05

Study design

Phase
Phase 4
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
98 participants (actual)

Study arms

  • Experimental
    Ramosetron group

    oral

    Drug: Ramosetron

  • Placebo comparator
    Placebo group

    oral

    Drug: Placebo

Interventions

  • DrugRamosetron

    oral

    Also known as: Irribow, YM060

  • DrugPlacebo

    oral

06

What researchers measure

Primary outcomes

  1. IBS severity index (Japanese version)

    Time frame: 12 weeks

Secondary outcomes

  1. Patient reported global assessment of relief of IBS symptoms

    Time frame: 12 weeks

  2. Patient reported assessment of relief of abdominal discomfort and/or pain

    Time frame: 12 weeks

  3. Patient reported assessment of improvement of abdominal bowel habits

    Time frame: 12 weeks

07

Study locations

4 sites
  • Hokkaido, Japan
  • Kansai, Japan
  • Kantou, Japan
  • Kyusyu, Japan
08

References and documents

Publications

  • Ida M, Nishida A, Akiho H, Nakashima Y, Matsueda K, Fukudo S. Randomized, placebo-controlled, phase IV pilot study of ramosetron to evaluate the co-primary end points in male patients with irritable bowel syndrome with diarrhea. Biopsychosoc Med. 2017 Mar 16;11:8. doi: 10.1186/s13030-017-0093-9. eCollection 2017. PubMed 28331539 ↗
  • Ida M, Nishida A, Akiho H, Nakashima Y, Matsueda K, Fukudo S. Evaluation of the irritable bowel syndrome severity index in Japanese male patients with irritable bowel syndrome with diarrhea. Biopsychosoc Med. 2017 Mar 11;11:7. doi: 10.1186/s13030-017-0092-x. eCollection 2017. PubMed 28293280 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 12, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00918411
Lead sponsor
Astellas Pharma Inc
Responsible party
Sponsor
First posted
Jun 11, 2009
Start date
Jun 2009
Primary completion
Dec 2009
Completion
Dec 2009
Last update
Oct 12, 2015

Study contacts

Use Central Contact
study chair · Astellas Pharma Inc

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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