A Study To Investigate The Safety And Efficacy Properties Of PF-00547659 In Patients With Active Ulcerative Colitis
NCT ID: NCT00928681
Last Updated: 2009-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
80 participants
INTERVENTIONAL
2005-09-30
2008-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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0.3 mg/kg or placebo sc
Single dose-group A
PF-00547659, single dose
Multiple dose-Group B
PF-00547659, multiple dose
0.1 mg/kg or placebo iv (multiple dose)
Multiple dose- Group B
PF-00547659, multiple dose
0.3 mg/kg or placebo iv (multiple dose)
Multiple dose- Group B
PF-00547659, multiple dose
3.0 mg/kg or placebo iv
Multiple dose- Group B
PF-00547659, multiple dose
0.1 mg/kg or placebo sc
Multiple dose- Group B
PF-00547659, multiple dose
0.3 mg/kg or placebo sc (multiple dose)
Multiple dose-Group B
PF-00547659, multiple dose
0.03 mg/kg or placebo iv
Single dose-group A
PF-00547659, single iv dose
0.1 mg/kg or placebo iv
Single dose-group A
PF-00547659, single iv dose
Multiple dose- Group B
PF-00547659, multiple dose
0.3 mg/kg or placebo iv
Single dose-group A
PF-00547659, single iv dose
Multiple dose- Group B
PF-00547659, multiple dose
1.0 mg/kg or placebo iv
Single dose-group A
PF-00547659, single dose
3.0 mg/kg or placebo sc
Single dose-group A
PF-00547659, single dose
10 mg/kg or placebo iv
Single dose-group A
PF-00547659, single dose
Interventions
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Single dose-group A
PF-00547659, single iv dose
Single dose-group A
PF-00547659, single iv dose
Multiple dose- Group B
PF-00547659, multiple dose
Single dose-group A
PF-00547659, single iv dose
Multiple dose- Group B
PF-00547659, multiple dose
Single dose-group A
PF-00547659, single dose
Single dose-group A
PF-00547659, single dose
Single dose-group A
PF-00547659, single dose
Single dose-group A
PF-00547659, single dose
Multiple dose-Group B
PF-00547659, multiple dose
Multiple dose- Group B
PF-00547659, multiple dose
Multiple dose- Group B
PF-00547659, multiple dose
Multiple dose- Group B
PF-00547659, multiple dose
Multiple dose- Group B
PF-00547659, multiple dose
Multiple dose-Group B
PF-00547659, multiple dose
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Pfizer, Inc.
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Brussels, , Belgium
Pfizer Investigational Site
Brussels, , Belgium
Pfizer Investigational Site
Leuven, , Belgium
Pfizer Investigational Site
Brno, , Czechia
Pfizer Investigational Site
Prague, , Czechia
Pfizer Investigational Site
Prague, , Czechia
Pfizer Investigational Site
Aarhus C, , Denmark
Pfizer Investigational Site
Berlin, , Germany
Pfizer Investigational Site
Kiel, , Germany
Pfizer Investigational Site
Münster, , Germany
Pfizer Investigational Site
Regensburg, , Germany
Pfizer Investigational Site
Oslo, , Norway
Pfizer Investigational Site
Nitra, , Slovakia
Pfizer Investigational Site
Barcelona, BARCELONA, Spain
Pfizer Investigational Site
Barcelona, BARCELONA, Spain
Pfizer Investigational Site
L'hospitalet DEL Llobregat, BARCELONA, Spain
Pfizer Investigational Site
Madrid, Madrid, Spain
Pfizer Investigational Site
Majadahonda, Madrid, Spain
Countries
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References
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Vermeire S, Ghosh S, Panes J, Dahlerup JF, Luegering A, Sirotiakova J, Strauch U, Burgess G, Spanton J, Martin SW, Niezychowski W. The mucosal addressin cell adhesion molecule antibody PF-00547,659 in ulcerative colitis: a randomised study. Gut. 2011 Aug;60(8):1068-75. doi: 10.1136/gut.2010.226548. Epub 2011 Feb 11.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A7281001
Identifier Type: -
Identifier Source: org_study_id
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