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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00232258
Recruitment Status : Completed
First Posted : October 4, 2005
Last Update Posted : December 10, 2008
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Ulcerative Colitis Inflammatory Bowel Disease Drug: Nolpitantium besylate Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 307 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Nolpitantium Besylate in Patients With Mild to Moderate Ulcerative Colitis, a Double-Blind, Placebo Controlled Efficacy and Safety, 8 Week Study
Study Start Date : April 2005
Primary Completion Date : September 2006
Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Clinical remission at 8 weeks defined as a clinical Mayo subscore </= 1

Secondary Outcome Measures :
  1. Clinical response defined as at least 3 point reduction from baseline on Clinical Mayo Sub-score
  2. Global change in overall Disease Activity Index
  3. Abdominal pain score at 8 weeks
  4. Safety profile

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00232258

Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
Sanofi-Aventis Administrative Office
Diegem, Belgium
Sanofi-Aventis Administrative Office
Sao Paulo, Brazil
Sanofi-Aventis Administrative Office
Laval, Canada
Sanofi-Aventis Administrative Office
Santiago, Chile
Czech Republic
Sanofi-Aventis Administrative Office
Praha, Czech Republic
Sanofi-Aventis Administrative Office
Tallinn, Estonia
Sanofi-Aventis Administrative Office
Budapest, Hungary
Sanofi-Aventis Administrative Office
Milano, Italy
Russian Federation
Sanofi-Aventis Administrative Office
Moscow, Russian Federation
Sanofi-Aventis Administrative Office
Singapore, Singapore
South Africa
Sanofi-Aventis Administrative Office
Midrand, South Africa
Sanofi-Aventis Administrative Office
Barcelona, Spain
Sanofi-Aventis Administrative Office
Bromma, Sweden
Sponsors and Collaborators
Principal Investigator: Gert Van Assche, MD Universitaire Ziekenhizen Leuven

Additional Information:
Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00232258     History of Changes
Other Study ID Numbers: DRI4553
First Posted: October 4, 2005    Key Record Dates
Last Update Posted: December 10, 2008
Last Verified: December 2008

Keywords provided by Sanofi:
NK1 Antagonist
Inflammatory Bowel Disease

Additional relevant MeSH terms:
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes