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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Nolpitantium Besylate in Patients With Mild to Moderate Ulcerative Colitis, a Double-Blind, Placebo Controlled Efficacy and Safety, 8 Week Study

Conditions
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Ulcerative Colitis, Inflammatory Bowel Disease

Intervention / Treatment
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* Drug: Nolpitantium besylate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Nolpitantium besylate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical remission at 8 weeks defined as a clinical Mayo subscore </= 1 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NK1 Antagonist, Inflammatory Bowel Disease, Mesalamine