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A Study To Investigate The Safety And Efficacy Properties Of PF-00547659 In Patients With Active Ulcerative Colitis

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Brussels, , B-1070 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ulcerative Colitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00928681
Pfizer
Completed
A Study To Investigate The Safety And Efficacy Properties Of PF-00547659 In Patients With Active Ulcerative Colitis

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A Study To Investigate The Safety And Efficacy Properties Of PF-00547659 In Patients With Active Ulcerative Colitis
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 to investigate the safety and efficacy properties of PF-00547659 in patients with active ulcerative colitis
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Colitis, Ulcerative
  • Biological: Single dose-group A
    PF-00547659, single iv dose
  • Biological: Multiple dose- Group B
    PF-00547659, multiple dose
  • Biological: Single dose-group A
    PF-00547659, single dose
  • Biological: Multiple dose-Group B
    PF-00547659, multiple dose
  • 0.03 mg/kg or placebo iv
    Intervention: Biological: Single dose-group A
  • 0.1 mg/kg or placebo iv
    Interventions:
    • Biological: Single dose-group A
    • Biological: Multiple dose- Group B
  • 0.3 mg/kg or placebo iv
    Interventions:
    • Biological: Single dose-group A
    • Biological: Multiple dose- Group B
  • Experimental: 1.0 mg/kg or placebo iv
    Intervention: Biological: Single dose-group A
  • 3.0 mg/kg or placebo sc
    Intervention: Biological: Single dose-group A
  • 10 mg/kg or placebo iv
    Intervention: Biological: Single dose-group A
  • 0.3 mg/kg or placebo sc
    Interventions:
    • Biological: Single dose-group A
    • Biological: Multiple dose-Group B
  • 0.1 mg/kg or placebo iv (multiple dose)
    Intervention: Biological: Multiple dose- Group B
  • 0.3 mg/kg or placebo iv (multiple dose)
    Intervention: Biological: Multiple dose- Group B
  • 3.0 mg/kg or placebo iv
    Intervention: Biological: Multiple dose- Group B
  • 0.1 mg/kg or placebo sc
    Intervention: Biological: Multiple dose- Group B
  • 0.3 mg/kg or placebo sc (multiple dose)
    Intervention: Biological: Multiple dose-Group B
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.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
October 2008
April 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Czech Republic,   Denmark,   Germany,   Norway,   Slovakia,   Spain
 
 
NCT00928681
A7281001
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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