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

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00232258

Purpose

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.

Condition	Intervention	Phase
Ulcerative Colitis Inflammatory Bowel Disease	Drug: Nolpitantium besylate	Phase II

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Ulcerative Colitis

Drug Information available for: Mesalamine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Nolpitantium Besylate in Patients With Mild to Moderate Ulcerative Colitis, a Double-Blind, Placebo Controlled Efficacy and Safety, 8 Week Study

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Clinical remission at 8 weeks defined as a clinical Mayo subscore </= 1

Secondary Outcome Measures:

Clinical response defined as at least 3 point reduction from baseline on Clinical Mayo Sub-score
Global change in overall Disease Activity Index
Abdominal pain score at 8 weeks
Safety profile

Enrollment:	307
Study Start Date:	April 2005
Study Completion Date:	September 2006
Primary Completion Date:	September 2006 (Final data collection date for primary outcome measure)

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00232258

Locations

Argentina
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
Belgium
Sanofi-Aventis Administrative Office
Diegem, Belgium
Brazil
Sanofi-Aventis Administrative Office
Sao Paulo, Brazil
Canada
Sanofi-Aventis Administrative Office
Laval, Canada
Chile
Sanofi-Aventis Administrative Office
Santiago, Chile
Czech Republic
Sanofi-Aventis Administrative Office
Praha, Czech Republic
Estonia
Sanofi-Aventis Administrative Office
Tallinn, Estonia
Hungary
Sanofi-Aventis Administrative Office
Budapest, Hungary
Italy
Sanofi-Aventis Administrative Office
Milano, Italy
Russian Federation
Sanofi-Aventis Administrative Office
Moscow, Russian Federation
Singapore
Sanofi-Aventis Administrative Office
Singapore, Singapore
South Africa
Sanofi-Aventis Administrative Office
Midrand, South Africa
Spain
Sanofi-Aventis Administrative Office
Barcelona, Spain
Sweden
Sanofi-Aventis Administrative Office
Bromma, Sweden

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Principal Investigator:

Gert Van Assche, MD

Universitaire Ziekenhizen Leuven

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	DRI4553
Study First Received:	October 3, 2005
Last Updated:	December 9, 2008
ClinicalTrials.gov Identifier:	NCT00232258
Health Authority:	Belgium: AFIGP; Czech Republic: State Institute for Drug Control; Estonia: The State Agency of Medicine; Hungary: National Institute of Pharmacy; Italy: The Italian Medicines Agency; Spain:Agencia Espanola de Mediacmentos y productos Sanitarios; Sweden: Medical Products Agency; Canada: Health Canada; South Africa: Medicines Control Council; Russia: Pharmacological Committee, Ministry of Health; Brazil: National Health Surveillance Agency

Keywords provided by Sanofi-Aventis:

NK1 Antagonist
Inflammatory Bowel Disease
Mesalamine

Study placed in the following topic categories:

Digestive System Diseases
Mesalamine
Gastrointestinal Diseases
Ulcer
Colonic Diseases

Inflammatory Bowel Diseases
Colitis, Ulcerative
Gastroenteritis
Intestinal Diseases
Colitis

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009