A Study of YM060 in Diarrhea-predominant Irritable Bowel Syndrome (d-IBS)

NCT ID: NCT00189813

Last Updated: 2014-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

691 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2005-12-31

Brief Summary

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

Detailed Description

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Conditions

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Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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YM060

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Europe B.V.

INDUSTRY

Sponsor Role collaborator

Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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F. Verbeeck

Role: STUDY_CHAIR

Director of Late Phase Development

Locations

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Plovdiv, , Bulgaria

Site Status

Sofia, , Bulgaria

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Varna, , Bulgaria

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České Budějovice, , Czechia

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Hradec Králové, , Czechia

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Ostrava Hrabuvka, , Czechia

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Prague, , Czechia

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Tábor, , Czechia

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Ústí nad Orlicí, , Czechia

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Tallinn, , Estonia

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Tartu, , Estonia

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Viljandi, , Estonia

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Berlin, , Germany

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Bochum, , Germany

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Dietzenbach, , Germany

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Essen, , Germany

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Frankfurt, , Germany

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Friedberg, , Germany

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Hamburg, , Germany

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Haßloch, , Germany

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Königstein, , Germany

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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

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Klaipėda, , Lithuania

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Vilnius, , Lithuania

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Bialystok, , Poland

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Bydgoszcz, , Poland

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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

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Moscow, , Russia

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Saint Petersburg, , Russia

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Yaroslavl, , Russia

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Dnipropetrovsk, , Ukraine

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Kiev, , Ukraine

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Lviv, , Ukraine

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Odesa, , Ukraine

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Simferopol, , Ukraine

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Sumy, , Ukraine

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Countries

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Bulgaria Czechia Estonia Germany Lithuania Poland Russia Ukraine

Other Identifiers

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060-CL-305

Identifier Type: -

Identifier Source: org_study_id

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