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

Primary Purpose

Ulcerative Colitis, Inflammatory Bowel Disease

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Nolpitantium besylate

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring NK1 Antagonist, Inflammatory Bowel Disease, Mesalamine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Outcomes

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

Full Information

NCT ID

NCT00232258

First Posted

October 3, 2005

Last Updated

December 9, 2008

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00232258

Brief Title

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

Acronym

NICE

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

2. Study Status

Record Verification Date

December 2008

Overall Recruitment Status

Completed

Study Start Date

April 2005 (undefined)

Primary Completion Date

September 2006 (Actual)

Study Completion Date

September 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ulcerative Colitis, Inflammatory Bowel Disease

Keywords

NK1 Antagonist, Inflammatory Bowel Disease, Mesalamine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

307 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Nolpitantium besylate

Primary Outcome Measure Information:

Title

Clinical remission at 8 weeks defined as a clinical Mayo subscore </= 1

Secondary Outcome Measure Information:

Title

Clinical response defined as at least 3 point reduction from baseline on Clinical Mayo Sub-score

Title

Global change in overall Disease Activity Index

Title

Abdominal pain score at 8 weeks

Title

Safety profile

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gert Van Assche, MD

Organizational Affiliation

Universitaire Ziekenhizen Leuven

Official's Role

Principal Investigator

Facility Information:

Facility Name