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Trial record 1 of 1 for:    NCT00928681
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A Study To Investigate The Safety And Efficacy Properties Of PF-00547659 In Patients With Active Ulcerative Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00928681
Recruitment Status : Completed
First Posted : June 26, 2009
Last Update Posted : June 26, 2009
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE June 22, 2009
First Posted Date  ICMJE June 26, 2009
Last Update Posted Date June 26, 2009
Study Start Date  ICMJE September 2005
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2009)
  • Safety and toleration [ Time Frame: up to 12 weeks ]
  • Endoscopic score changes as calculated using section 3 of the Mayo Score [ Time Frame: up to 12 weeks ]
  • Disease activity score changes as calculated using the Mayo Score [ Time Frame: up to 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2009)
  • Plasma concentrations of PF-00547659 [ Time Frame: up to 12 weeks ]
  • Fecal concentrations of calprotectin [ Time Frame: up to 12 weeks ]
  • Plasma concentrations of CRP [ Time Frame: up to 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study To Investigate The Safety And Efficacy Properties Of PF-00547659 In Patients With Active Ulcerative Colitis
Official Title  ICMJE 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.
Brief Summary study to investigate the safety and efficacy properties of PF-00547659 in patients with active ulcerative colitis
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Colitis, Ulcerative
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 25, 2009)
80
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Czech Republic,   Denmark,   Germany,   Norway,   Slovakia,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00928681
Other Study ID Numbers  ICMJE A7281001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP