Clinical trial NCT00232258: Nolpitantium Besylate In Patients With Ulcerative Colitis a Double-Blind, Placebo Controlled Efficacy and Safety Study
Official title: Nolpitantium Besylate in Patients With Mild to Moderate Ulcerative Colitis, a Double-Blind, Placebo Controlled Efficacy and Safety, 8 Week Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ulcerative Colitis
Inflammatory Bowel Disease
Keywords: NK1 Antagonist
Inflammatory Bowel Disease
Mesalamine
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-10-04
Enrollment: 307
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Clinical remission at 8 weeks defined as a clinical Mayo subscore </= 1
Secondary outcomes:
measure: Clinical response defined as at least 3 point reduction from baseline on Clinical Mayo Sub-score
measure: Global change in overall Disease Activity Index
measure: Abdominal pain score at 8 weeks
measure: Safety profile
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Sanofi-Aventis Administrative Office
city: Diegem
country: Belgium
facility: Sanofi-Aventis Administrative Office
city: Sao Paulo
country: Brazil
facility: Sanofi-Aventis Administrative Office
city: Laval
country: Canada
facility: Sanofi-Aventis Administrative Office
city: Santiago
country: Chile
facility: Sanofi-Aventis Administrative Office
city: Praha
country: Czech Republic
facility: Sanofi-Aventis Administrative Office
city: Tallinn
country: Estonia
facility: Sanofi-Aventis Administrative Office
city: Budapest
country: Hungary
facility: Sanofi-Aventis Administrative Office
city: Milano
country: Italy
facility: Sanofi-Aventis Administrative Office
city: Moscow
country: Russian Federation
facility: Sanofi-Aventis Administrative Office
city: Singapore
country: Singapore
facility: Sanofi-Aventis Administrative Office
city: Midrand
country: South Africa
facility: Sanofi-Aventis Administrative Office
city: Barcelona
country: Spain
facility: Sanofi-Aventis Administrative Office
city: Bromma
country: Sweden
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Universitaire Ziekenhizen Leuven
name: Gert Van Assche, MD
role: PRINCIPAL_INVESTIGATOR
References: