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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00232258
First received: October 3, 2005
Last updated: December 9, 2008
Last verified: December 2008
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Gert Van Assche, MD Universitaire Ziekenhizen Leuven
  More Information

Additional Information:
No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00232258     History of Changes
Other Study ID Numbers: DRI4553
Study First Received: October 3, 2005
Last Updated: December 9, 2008
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:
NK1 Antagonist
Inflammatory Bowel Disease
Mesalamine

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

ClinicalTrials.gov processed this record on September 16, 2014