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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

307

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Apr 2005

Shorter than P25 for phase_2

Geographic Reach

13 countries

13 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.4 years study duration

Study Start

First participant enrolled

April 1, 2005

Completed

6 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2005

Completed

1 day until next milestone

First Posted

Study publicly available on registry

October 4, 2005

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed

Last Updated

December 10, 2008

Status Verified

December 1, 2008

Enrollment Period

1.4 years

First QC Date

October 3, 2005

Last Update Submit

December 9, 2008

Conditions

Ulcerative Colitis Inflammatory Bowel Disease

Keywords

NK1 AntagonistInflammatory Bowel DiseaseMesalamine

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

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

Interventions

Nolpitantium besylateDRUG

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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)

You may not qualify if:

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

Contact the study team to confirm eligibility.