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

NCT00928681

Last updated date
Study Location
Pfizer Investigational Site
Brussels, , B-1070, Belgium
Contact
1-800-718-1021

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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.

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Advanced Information
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 CenterPfizer
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