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

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ClinicalTrials.gov Identifier: NCT00232258
Recruitment Status : Completed
First Posted : October 4, 2005
Last Update Posted : December 10, 2008
Sponsor:
Information provided by:
Sanofi

Tracking Information
First Submitted Date  ICMJE October 3, 2005
First Posted Date  ICMJE October 4, 2005
Last Update Posted Date December 10, 2008
Study Start Date  ICMJE April 2005
Actual Primary Completion Date September 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2005)
Clinical remission at 8 weeks defined as a clinical Mayo subscore </= 1
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00232258 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2005)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nolpitantium Besylate In Patients With Ulcerative Colitis a Double-Blind, Placebo Controlled Efficacy and Safety Study
Official Title  ICMJE Nolpitantium Besylate in Patients With Mild to Moderate Ulcerative Colitis, a Double-Blind, Placebo Controlled Efficacy and Safety, 8 Week Study
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Ulcerative Colitis
  • Inflammatory Bowel Disease
Intervention  ICMJE Drug: Nolpitantium besylate
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 9, 2008)
307
Original Enrollment  ICMJE
 (submitted: October 3, 2005)
300
Actual Study Completion Date  ICMJE September 2006
Actual Primary Completion Date September 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden,   Argentina,   Belgium,   Brazil,   Canada,   Chile,   Czech Republic,   Estonia,   Hungary,   Italy,   Russian Federation,   Singapore,   South Africa,   Spain
Removed Location Countries France,   United States
 
Administrative Information
NCT Number  ICMJE NCT00232258
Other Study ID Numbers  ICMJE DRI4553
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ICD Study Director, sanofi-aventis
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gert Van Assche, MD Universitaire Ziekenhizen Leuven
PRS Account Sanofi
Verification Date December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP