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

June 25, 2009 updated by: Pfizer

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, B-1070
        • Pfizer Investigational Site
      • Bruxelles, Belgium, 1200
        • Pfizer Investigational Site
      • Leuven, Belgium, 3000
        • Pfizer Investigational Site
  • Czech Republic
      • Brno, Czech Republic, 625 00
        • Pfizer Investigational Site
      • Praha 2, Czech Republic, 120 00
        • Pfizer Investigational Site
      • Praha 2, Czech Republic, 128 01
        • Pfizer Investigational Site
  • Denmark
      • Aarhus C, Denmark, 8000
        • Pfizer Investigational Site
  • Germany
      • Berlin, Germany, 10117
        • Pfizer Investigational Site
      • Kiel, Germany, 24105
        • Pfizer Investigational Site
      • Muenster, Germany, 48129
        • Pfizer Investigational Site
      • Regensburg, Germany, 93042
        • Pfizer Investigational Site
  • Norway
      • Oslo, Norway, 0027
        • Pfizer Investigational Site
  • Slovakia
      • Nitra, Slovakia, 950 01
        • Pfizer Investigational Site
  • Spain
      • Barcelona, Spain, 08035
        • Pfizer Investigational Site
      • Barcelona, Spain, 08025
        • Pfizer Investigational Site
      • Madrid, Spain, 28040
        • Pfizer Investigational Site
    • Barcelona
      • L'hospitalet Del Llobregat, Barcelona, Spain, 08907
        • Pfizer Investigational Site
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 0.03 mg/kg or placebo iv
Biological: Single dose-group A
PF-00547659, single iv dose
Biological: Single dose-group A
PF-00547659, single dose
OTHER: 0.1 mg/kg or placebo iv
Biological: Single dose-group A
PF-00547659, single iv dose
Biological: Single dose-group A
PF-00547659, single dose
Biological: Multiple dose- Group B
PF-00547659, multiple dose
OTHER: 0.3 mg/kg or placebo iv
Biological: Single dose-group A
PF-00547659, single iv dose
Biological: Single dose-group A
PF-00547659, single dose
Biological: Multiple dose- Group B
PF-00547659, multiple dose
EXPERIMENTAL: 1.0 mg/kg or placebo iv
Biological: Single dose-group A
PF-00547659, single iv dose
Biological: Single dose-group A
PF-00547659, single dose
OTHER: 3.0 mg/kg or placebo sc
Biological: Single dose-group A
PF-00547659, single iv dose
Biological: Single dose-group A
PF-00547659, single dose
OTHER: 10 mg/kg or placebo iv
Biological: Single dose-group A
PF-00547659, single iv dose
Biological: Single dose-group A
PF-00547659, single dose
OTHER: 0.3 mg/kg or placebo sc
Biological: Single dose-group A
PF-00547659, single iv dose
Biological: Single dose-group A
PF-00547659, single dose
Biological: Multiple dose-Group B
PF-00547659, multiple dose
OTHER: 0.1 mg/kg or placebo iv (multiple dose)
Biological: Multiple dose- Group B
PF-00547659, multiple dose
OTHER: 0.3 mg/kg or placebo iv (multiple dose)
Biological: Multiple dose- Group B
PF-00547659, multiple dose
OTHER: 3.0 mg/kg or placebo iv
Biological: Multiple dose- Group B
PF-00547659, multiple dose
OTHER: 0.1 mg/kg or placebo sc
Biological: Multiple dose- Group B
PF-00547659, multiple dose
OTHER: 0.3 mg/kg or placebo sc (multiple dose)
Biological: Multiple dose-Group B
PF-00547659, multiple dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and toleration
Time Frame: up to 12 weeks
up to 12 weeks
Endoscopic score changes as calculated using section 3 of the Mayo Score
Time Frame: up to 12 weeks
up to 12 weeks
Disease activity score changes as calculated using the Mayo Score
Time Frame: up to 12 weeks
up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma concentrations of PF-00547659
Time Frame: up to 12 weeks
up to 12 weeks
Fecal concentrations of calprotectin
Time Frame: up to 12 weeks
up to 12 weeks
Plasma concentrations of CRP
Time Frame: up to 12 weeks
up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (ACTUAL)

April 1, 2008

Study Completion (ACTUAL)

October 1, 2008

Study Registration Dates

First Submitted

June 22, 2009

First Submitted That Met QC Criteria

June 25, 2009

First Posted (ESTIMATE)

June 26, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

June 26, 2009

Last Update Submitted That Met QC Criteria

June 25, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A7281001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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