NCT01736423

Brief Summary

To evaluate the efficacy and safety of YM060 once daily for female patients with diarrhea-predominant irritable bowel syndrome (D-IBS) for a long-term period (up to 52 weeks).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 29, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

October 12, 2015

Status Verified

October 1, 2015

Enrollment Period

1.7 years

First QC Date

November 27, 2012

Last Update Submit

October 9, 2015

Conditions

Diarrhea-predominant Irritable Bowel Syndrome

Keywords

YM060Ramosetronlong term studyDiarrhea-predominant Irritable Bowel SyndromeFemale

Outcome Measures

Primary Outcomes (10)

  • Monthly responder rate of global assessment of relief of overall IBS symptoms

    up to 52 weeks

  • Monthly responder rate of stool form normalization

    up to 52 weeks

  • Monthly responder rate of global assessment of relief of abdominal pain/discomfort

    up to 52 weeks

  • Monthly responder rate of global assessment of improvement of abnormal bowel habits

    up to 52 weeks

  • Change in weekly average of scores of severity of abdominal pain/discomfort

    up to 52 weeks

  • Change in weekly average of scores of stool form

    up to 52 weeks

  • Change in weekly average of stool frequency

    up to 52 weeks

  • Rate of days without urgency

    up to 52 weeks

  • Rate of days without feeling of incomplete bowel movement

    up to 52 weeks

  • Change in entire Japanese version of Irritable Bowel Syndrome Quality of Life (IBS-QOL-J) scores and pairwise IBS-QOL-J scores on the sub-scales

    4, 8, 12, 28 and 52 weeks

Secondary Outcomes (1)

  • Safety assessed through AEs and clinical laboratory values

    up to 52 weeks

Study Arms (1)

Female Patients with D-IBS

EXPERIMENTAL
Drug: YM060

Interventions

YM060DRUG

oral

Also known as: Ramosetron
Female Patients with D-IBS

Eligibility Criteria

Age20 Years - 64 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female patients who meet the following criteria:
  • Patients satisfying the Rome III Diagnostic Criteria
  • Patients whose ≥25% of stools were loose or watery and \<25% of them were hard or lumpy stools
  • Patients who have abdominal pain or discomfort
  • Patients in whom after occurrence of IBS symptoms the following tests were conducted and in whom no organic changes were observed Pancolonoscopy or contrast enema

You may not qualify if:

  • Patients who meet any of the following criteria:
  • Patients with a history of surgical resection of the stomach,gallbladder, small intestine or large intestine
  • Patients with a history or current evidence of inflammatory bowel disease
  • Patients with a history or current evidence of colitis ischemic
  • Patients with concurrent infectious enteritis
  • Patients with concurrent hyperthyroidism or hypothyroidism
  • Patients with concurrent active peptic ulcer
  • Patients with other concurrent disease that may affect the digestive tract passage or large intestinal function or that is likely to interfere with proper assessment of IBS abdominal pain/discomfort

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Hokkaido, Japan

Location

Unknown Facility

Kansai, Japan

Location

Unknown Facility

Kantou, Japan

Location

Unknown Facility

Kyushu, Japan

Location

Related Publications (1)

  • Fukudo S, Kinoshita Y, Okumura T, Ida M, Hayashi K, Akiho H, Nakashima Y, Haruma K. Effect of ramosetron in female patients with irritable bowel syndrome with diarrhea: a phase III long-term study. J Gastroenterol. 2016 Sep;51(9):874-82. doi: 10.1007/s00535-016-1165-5. Epub 2016 Jan 22.

    PMID: 26800997DERIVED

Related Links

MeSH Terms

Interventions

ramosetron

Study Officials

  • Medical Director

    Astellas Pharma Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2012

First Posted

November 29, 2012

Study Start

September 1, 2012

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

October 12, 2015

Record last verified: 2015-10

Locations

JP(4)