Status:
COMPLETED
A Study To Investigate The Safety And Efficacy Properties Of PF-00547659 In Patients With Active Ulcerative Colitis
Lead Sponsor:
Pfizer
Conditions:
Colitis, Ulcerative
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
study to investigate the safety and efficacy properties of PF-00547659 in patients with active ulcerative colitis
Eligibility Criteria
Inclusion
- A positive histological diagnosis of UC ≥3 months prior to entry into the study. If a histological diagnosis is not available but all signs and symptoms suggest UC, the subject's eligibility should be discussed with Pfizer.
- Active UC as defined by a score of ≥6 on the Mayo score.
- An endoscopic (by flexible sigmoidoscopy) sub-score of ≥2 on the Mayo score determined within 7 days of first dosing.
Exclusion
- Subjects with UC, which is confined to a proctitis on a flexible sigmoidoscopy.
- Subjects who have had surgery as a treatment for UC or are likely to require surgery within the duration of the study.
- Subjects displaying clinical signs of ischemic colitis.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00928681
Start Date
September 1 2005
End Date
October 1 2008
Last Update
June 26 2009
Active Locations (18)
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1
Pfizer Investigational Site
Brussels, Belgium, 1200
2
Pfizer Investigational Site
Brussels, Belgium, B-1070
3
Pfizer Investigational Site
Leuven, Belgium, 3000
4
Pfizer Investigational Site
Brno, Czechia, 625 00