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Nolpitantium Besylate In Patients With Ulcerative Colitis a Double-Blind, Placebo Controlled Efficacy and Safety Study

NCT ID: NCT00232258

Last Updated: 2008-12-10

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

307 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2006-09-30

Brief Summary

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To evaluate the safety and efficacy on clinical symptoms, mucosal histology and endoscopic mucosal appearance of two doses of SR140333B against placebo in patients with mild to moderate ulcerative colitis resistant to treatment with 5-ASA.

Detailed Description

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Patients with active mild to moderate ulcerative colitis that has not responded to a minimum of 4 weeks of 5-ASA will be randomized to receive single daily doses of either placebo, 600 mg SR140333B or 1800 mg of SR140333B for eight weeks. Patients will undergo baseline and end of study sigmoidoscopic assessments and complete daily symptom diaries during the study. Ulcerative colitis disease activity will be measured by both the overall and component subscores of the Mayo Disease Activity Index.

Conditions

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Ulcerative Colitis Inflammatory Bowel Disease

Keywords

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NK1 Antagonist Inflammatory Bowel Disease Mesalamine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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Nolpitantium besylate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age at least 18 years
* Ulcerative colitis of at least 6 months duration
* Patient's ulcerative colitis should remain active while taking 5-ASA or sulfasalazine for at least 4 week
* If taking corticosteroids, dose must be stable for at least 2 weeks prior to enrollment and not exceed 20 mg per day (prednisolone equivalent)

Exclusion Criteria

* Crohn's disease
* Colonic dysplasia
* Stool culture positive for enteric pathogens
* Concurrent cancer or unstable medical condition
* Recent treatment with monoclonal antibody
* Recent introduction of thiazolidinedione
* Recent treatment with methotrexate or cyclosporine
* Recent treatment with an antibiotic prescribed for ulcerative colitis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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sanofi-aventis

Principal Investigators

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Gert Van Assche, MD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhizen Leuven

Locations

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Sanofi-Aventis Administrative Office

Buenos Aires, , Argentina

Site Status

Sanofi-Aventis Administrative Office

Diegem, , Belgium

Site Status

Sanofi-Aventis Administrative Office

São Paulo, , Brazil

Site Status

Sanofi-Aventis Administrative Office

Laval, , Canada

Site Status

Sanofi-Aventis Administrative Office

Santiago, , Chile

Site Status

Sanofi-Aventis Administrative Office

Prague, , Czechia

Site Status

Sanofi-Aventis Administrative Office

Tallinn, , Estonia

Site Status

Sanofi-Aventis Administrative Office

Budapest, , Hungary

Site Status

Sanofi-Aventis Administrative Office

Milan, , Italy

Site Status

Sanofi-Aventis Administrative Office

Moscow, , Russia

Site Status

Sanofi-Aventis Administrative Office

Singapore, , Singapore

Site Status

Sanofi-Aventis Administrative Office

Midrand, , South Africa

Site Status

Sanofi-Aventis Administrative Office

Barcelona, , Spain

Site Status

Sanofi-Aventis Administrative Office

Bromma, , Sweden

Site Status

Countries

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France United States Argentina Belgium Brazil Canada Chile Czechia Estonia Hungary Italy Russia Singapore South Africa Spain Sweden

Related Links

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http://www.sanofi-aventis.com

Related Info

Other Identifiers

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DRI4553

Identifier Type: -

Identifier Source: org_study_id