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

Primary Purpose

Colitis, Ulcerative

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Single dose-group A
Single dose-group A
Multiple dose- Group B
Single dose-group A
Multiple dose- Group B
Single dose-group A
Single dose-group A
Single dose-group A
Single dose-group A
Multiple dose-Group B
Multiple dose- Group B
Multiple dose- Group B
Multiple dose- Group B
Multiple dose- Group B
Multiple dose-Group B
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colitis, Ulcerative

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm Type

Other

Other

Other

Experimental

Other

Other

Other

Other

Other

Other

Other

Other

Arm Label

0.03 mg/kg or placebo iv

0.1 mg/kg or placebo iv

0.3 mg/kg or placebo iv

1.0 mg/kg or placebo iv

3.0 mg/kg or placebo sc

10 mg/kg or placebo iv

0.3 mg/kg or placebo sc

0.1 mg/kg or placebo iv (multiple dose)

0.3 mg/kg or placebo iv (multiple dose)

3.0 mg/kg or placebo iv

0.1 mg/kg or placebo sc

0.3 mg/kg or placebo sc (multiple dose)

Arm Description

Outcomes

Primary Outcome Measures

Safety and toleration
Endoscopic score changes as calculated using section 3 of the Mayo Score
Disease activity score changes as calculated using the Mayo Score

Secondary Outcome Measures

Plasma concentrations of PF-00547659
Fecal concentrations of calprotectin
Plasma concentrations of CRP

Full Information

First Posted
June 22, 2009
Last Updated
June 25, 2009
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00928681
Brief Title
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

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colitis, Ulcerative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.03 mg/kg or placebo iv
Arm Type
Other
Arm Title
0.1 mg/kg or placebo iv
Arm Type
Other
Arm Title
0.3 mg/kg or placebo iv
Arm Type
Other
Arm Title
1.0 mg/kg or placebo iv
Arm Type
Experimental
Arm Title
3.0 mg/kg or placebo sc
Arm Type
Other
Arm Title
10 mg/kg or placebo iv
Arm Type
Other
Arm Title
0.3 mg/kg or placebo sc
Arm Type
Other
Arm Title
0.1 mg/kg or placebo iv (multiple dose)
Arm Type
Other
Arm Title
0.3 mg/kg or placebo iv (multiple dose)
Arm Type
Other
Arm Title
3.0 mg/kg or placebo iv
Arm Type
Other
Arm Title
0.1 mg/kg or placebo sc
Arm Type
Other
Arm Title
0.3 mg/kg or placebo sc (multiple dose)
Arm Type
Other
Intervention Type
Biological
Intervention Name(s)
Single dose-group A
Intervention Description
PF-00547659, single iv dose
Intervention Type
Biological
Intervention Name(s)
Single dose-group A
Intervention Description
PF-00547659, single iv dose
Intervention Type
Biological
Intervention Name(s)
Multiple dose- Group B
Intervention Description
PF-00547659, multiple dose
Intervention Type
Biological
Intervention Name(s)
Single dose-group A
Intervention Description
PF-00547659, single iv dose
Intervention Type
Biological
Intervention Name(s)
Multiple dose- Group B
Intervention Description
PF-00547659, multiple dose
Intervention Type
Biological
Intervention Name(s)
Single dose-group A
Intervention Description
PF-00547659, single dose
Intervention Type
Biological
Intervention Name(s)
Single dose-group A
Intervention Description
PF-00547659, single dose
Intervention Type
Biological
Intervention Name(s)
Single dose-group A
Intervention Description
PF-00547659, single dose
Intervention Type
Biological
Intervention Name(s)
Single dose-group A
Intervention Description
PF-00547659, single dose
Intervention Type
Biological
Intervention Name(s)
Multiple dose-Group B
Intervention Description
PF-00547659, multiple dose
Intervention Type
Biological
Intervention Name(s)
Multiple dose- Group B
Intervention Description
PF-00547659, multiple dose
Intervention Type
Biological
Intervention Name(s)
Multiple dose- Group B
Intervention Description
PF-00547659, multiple dose
Intervention Type
Biological
Intervention Name(s)
Multiple dose- Group B
Intervention Description
PF-00547659, multiple dose
Intervention Type
Biological
Intervention Name(s)
Multiple dose- Group B
Intervention Description
PF-00547659, multiple dose
Intervention Type
Biological
Intervention Name(s)
Multiple dose-Group B
Intervention Description
PF-00547659, multiple dose
Primary Outcome Measure Information:
Title
Safety and toleration
Time Frame
up to 12 weeks
Title
Endoscopic score changes as calculated using section 3 of the Mayo Score
Time Frame
up to 12 weeks
Title
Disease activity score changes as calculated using the Mayo Score
Time Frame
up to 12 weeks
Secondary Outcome Measure Information:
Title
Plasma concentrations of PF-00547659
Time Frame
up to 12 weeks
Title
Fecal concentrations of calprotectin
Time Frame
up to 12 weeks
Title
Plasma concentrations of CRP
Time Frame
up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Brussels
ZIP/Postal Code
B-1070
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Brno
ZIP/Postal Code
625 00
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Praha 2
ZIP/Postal Code
120 00
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Praha 2
ZIP/Postal Code
128 01
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Pfizer Investigational Site
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Pfizer Investigational Site
City
Muenster
ZIP/Postal Code
48129
Country
Germany
Facility Name
Pfizer Investigational Site
City
Regensburg
ZIP/Postal Code
93042
Country
Germany
Facility Name
Pfizer Investigational Site
City
Oslo
ZIP/Postal Code
0027
Country
Norway
Facility Name
Pfizer Investigational Site
City
Nitra
ZIP/Postal Code
950 01
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
L'hospitalet Del Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Pfizer Investigational Site
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
21317177
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A7281001&StudyName=A%20Study%20To%20Investigate%20The%20Safety%20And%20Efficacy%20Properties%20Of%20PF-00547659%20In%20Patients%20With%20Active%20Ulcerative%20Colitis
Description
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A Study To Investigate The Safety And Efficacy Properties Of PF-00547659 In Patients With Active Ulcerative Colitis

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