NCT00189813

Brief Summary

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

Trial Health

93
On Track

Trial Health Score

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

Enrollment
691

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2005

Shorter than P25 for phase_2

Geographic Reach
8 countries

45 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

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

August 28, 2014

Status Verified

August 1, 2014

Enrollment Period

9 months

First QC Date

September 13, 2005

Last Update Submit

August 27, 2014

Conditions

Irritable Bowel Syndrome

Keywords

Irritable Bowel SyndromeDiarrheaNasea®Irribow®ramosetron

Interventions

YM060DRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient meets Rome II criteria for IBS and the subgroup of diarrhea predominant IBS

You may not qualify if:

  • Patient with severe cardiovascular disease, respiratory diseases, renal diseases, hepatic diseases, digestive tract diseases (excluding IBS), blood diseases, or neurological or psychiatric diseases
  • Patient reported having any Type 1 or Type 2 stool on the Bristol Stool Form Scale during the run-in period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (45)

Unknown Facility

Plovdiv, Bulgaria

Location

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Sofia, Bulgaria

Location

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Varna, Bulgaria

Location

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České Budějovice, Czechia

Location

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Hradec Králové, Czechia

Location

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Ostrava Hrabuvka, Czechia

Location

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Prague, Czechia

Location

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Tábor, Czechia

Location

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Ústí nad Orlicí, Czechia

Location

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Tallinn, Estonia

Location

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Tartu, Estonia

Location

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Viljandi, Estonia

Location

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Berlin, Germany

Location

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Bochum, Germany

Location

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Dietzenbach, Germany

Location

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Essen, Germany

Location

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Frankfurt, Germany

Location

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Friedberg, Germany

Location

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Hamburg, Germany

Location

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Haßloch, Germany

Location

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Königstein, Germany

Location

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Leipzig, Germany

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Mainz, Germany

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Marburg, Germany

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Potsdam, Germany

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Waltershausen, Germany

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Kaunas, Lithuania

Location

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Klaipėda, Lithuania

Location

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Vilnius, Lithuania

Location

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Bialystok, Poland

Location

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Bydgoszcz, Poland

Location

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Krakow, Poland

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Leszno, Poland

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Lublin, Poland

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Oława, Poland

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Warsaw, Poland

Location

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Moscow, Russia

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Saint Petersburg, Russia

Location

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Yaroslavl, Russia

Location

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Dnipropetrovsk, Ukraine

Location

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Kiev, Ukraine

Location

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Lviv, Ukraine

Location

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Odesa, Ukraine

Location

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Simferopol, Ukraine

Location

Unknown Facility

Sumy, Ukraine

Location

MeSH Terms

Conditions

Irritable Bowel SyndromeDiarrhea

Interventions

ramosetron

Condition Hierarchy (Ancestors)

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

Study Officials

  • F. Verbeeck

    Director of Late Phase Development

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 19, 2005

Study Start

March 1, 2005

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

August 28, 2014

Record last verified: 2014-08

Locations

PL(7)BU(3)LI(3)CZ(6)DE(14)RU(3)ES(3)UA(6)