NCT01274000

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
409

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2010

Shorter than P25 for phase_2

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

November 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 11, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

October 12, 2015

Status Verified

October 1, 2015

Enrollment Period

11 months

First QC Date

January 5, 2011

Last Update Submit

October 9, 2015

Conditions

Irritable Bowel Syndrome

Keywords

diarrheaIBSColonic diseaseYM060Ramosetron

Outcome Measures

Primary Outcomes (1)

  • Responder rate of patients reported global assessment of relief of IBS symptoms

    for 4 weeks

Secondary Outcomes (4)

  • 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

Study Arms (4)

placebo group

PLACEBO COMPARATOR
Drug: placebo

YM060 low-dose group

EXPERIMENTAL
Drug: YM060

YM060 middle-dose group

EXPERIMENTAL
Drug: YM060

YM060 high-dose group

EXPERIMENTAL
Drug: YM060

Interventions

YM060DRUG

oral

Also known as: ramosetron, Irribow
YM060 high-dose groupYM060 low-dose groupYM060 middle-dose group
placeboDRUG

oral

placebo group

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

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

Kyusyu, Japan

Location

Related Publications (1)

  • Fukudo S, Matsueda K, Haruma K, Ida M, Hayase H, Akiho H, Nakashima Y, Hongo M. Optimal dose of ramosetron in female patients with irritable bowel syndrome with diarrhea: A randomized, placebo-controlled phase II study. Neurogastroenterol Motil. 2017 Jun;29(6). doi: 10.1111/nmo.13023. Epub 2017 Feb 16.

    PMID: 28205278DERIVED

Related Links

MeSH Terms

Conditions

Irritable Bowel SyndromeDiarrheaColonic Diseases

Interventions

ramosetron

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Use Central Contact

    Astellas Pharma Inc

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2011

First Posted

January 11, 2011

Study Start

November 1, 2010

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

October 12, 2015

Record last verified: 2015-10

Locations

JP(4)