Clinical trial NCT00928681: A Study To Investigate The Safety And Efficacy Properties Of PF-00547659 In Patients With Active Ulcerative Colitis
Official title: A Randomized, Double-Blind (Sponsor Open), Placebo Controlled, Dose Escalating, Parallel Group, Multi-Centre Study To Investigate The Safety, Toleration, Pharmacokinetics And Pharmacodynamics Of Single And Multiple Intravenous/Sub-Cutaneous Doses Of PF-00547659 In Patients With Active Ulcerative Colitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Colitis, Ulcerative
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-06-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: study to investigate the safety and efficacy properties of PF-00547659 in patients with active ulcerative colitis


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Safety and toleration
timeFrame: up to 12 weeks
measure: Endoscopic score changes as calculated using section 3 of the Mayo Score
timeFrame: up to 12 weeks
measure: Disease activity score changes as calculated using the Mayo Score
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Plasma concentrations of PF-00547659
timeFrame: up to 12 weeks
measure: Fecal concentrations of calprotectin
timeFrame: up to 12 weeks
measure: Plasma concentrations of CRP
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Pfizer Investigational Site
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Leuven
country: Belgium
facility: Pfizer Investigational Site
city: Brno
country: Czech Republic
facility: Pfizer Investigational Site
city: Praha 2
country: Czech Republic
facility: Pfizer Investigational Site
city: Praha 2
country: Czech Republic
facility: Pfizer Investigational Site
city: Aarhus C
country: Denmark
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Kiel
country: Germany
facility: Pfizer Investigational Site
city: Muenster
country: Germany
facility: Pfizer Investigational Site
city: Regensburg
country: Germany
facility: Pfizer Investigational Site
city: Oslo
country: Norway
facility: Pfizer Investigational Site
city: Nitra
country: Slovakia
facility: Pfizer Investigational Site
city: L'hospitalet Del Llobregat
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Majadahonda
country: Spain
facility: Pfizer Investigational Site
state: Madrid
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.