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

Ulcerative Colitis Clinical Trial

— NICE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00232258
• Other study ID #: DRI4553
• Status: Completed
• Phase: Phase 2
• First received: October 3, 2005
• Last updated: December 9, 2008
• Start date: April 2005
• Est. completion date: September 2006

Study information

• Verified date: December 2008
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: AFIGPCzech Republic: State Institute for Drug ControlEstonia: The State Agency of MedicineHungary: National Institute of PharmacyItaly: The Italian Medicines AgencySpain:Agencia Espanola de Mediacmentos y productos SanitariosSweden: Medical Products AgencyCanada: Health CanadaSouth Africa: Medicines Control CouncilRussia: Pharmacological Committee, Ministry of HealthBrazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 307
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Nolpitantium besylate

Locations

Country	Name	City	State
Argentina	Sanofi-Aventis Administrative Office	Buenos Aires
Belgium	Sanofi-Aventis Administrative Office	Diegem
Brazil	Sanofi-Aventis Administrative Office	Sao Paulo
Canada	Sanofi-Aventis Administrative Office	Laval
Chile	Sanofi-Aventis Administrative Office	Santiago
Czech Republic	Sanofi-Aventis Administrative Office	Praha
Estonia	Sanofi-Aventis Administrative Office	Tallinn
Hungary	Sanofi-Aventis Administrative Office	Budapest
Italy	Sanofi-Aventis Administrative Office	Milano
Russian Federation	Sanofi-Aventis Administrative Office	Moscow
Singapore	Sanofi-Aventis Administrative Office	Singapore
South Africa	Sanofi-Aventis Administrative Office	Midrand
Spain	Sanofi-Aventis Administrative Office	Barcelona
Sweden	Sanofi-Aventis Administrative Office	Bromma

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Argentina,  Belgium,  Brazil,  Canada,  Chile,  Czech Republic,  Estonia,  Hungary,  Italy,  Russian Federation,  Singapore,  South Africa,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical remission at 8 weeks defined as a clinical Mayo subscore </= 1
Secondary	Clinical response defined as at least 3 point reduction from baseline on Clinical Mayo Sub-score
Secondary	Global change in overall Disease Activity Index
Secondary	Abdominal pain score at 8 weeks
Secondary	Safety profile

External Links

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