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NCT00928681 Clinical Trial

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

Colitis, Ulcerative Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00928681
Other study ID # A7281001
Secondary ID
Status Completed
Phase Phase 1
First received June 22, 2009
Last updated June 25, 2009
Start date September 2005
Est. completion date October 2008

Study information
Verified date June 2009
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Germany: Bfarm
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date October 2008
Est. primary completion date April 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Biological:
• Single dose-group A
PF-00547659, single iv dose
• Single dose-group A
PF-00547659, single iv dose
• Multiple dose- Group B
PF-00547659, multiple dose
• Single dose-group A
PF-00547659, single iv dose
• Multiple dose- Group B
PF-00547659, multiple dose
• Single dose-group A
PF-00547659, single dose
• Single dose-group A
PF-00547659, single dose
• Single dose-group A
PF-00547659, single dose
• Single dose-group A
PF-00547659, single dose
• Multiple dose-Group B
PF-00547659, multiple dose
• Multiple dose- Group B
PF-00547659, multiple dose
• Multiple dose- Group B
PF-00547659, multiple dose
• Multiple dose- Group B
PF-00547659, multiple dose
• Multiple dose- Group B
PF-00547659, multiple dose
• Multiple dose-Group B
PF-00547659, multiple dose

Locations
Country Name City State
Belgium Pfizer Investigational Site Brussels
Belgium Pfizer Investigational Site Bruxelles
Belgium Pfizer Investigational Site Leuven
Czech Republic Pfizer Investigational Site Brno
Czech Republic Pfizer Investigational Site Praha 2
Czech Republic Pfizer Investigational Site Praha 2
Denmark Pfizer Investigational Site Aarhus C
Germany Pfizer Investigational Site Berlin
Germany Pfizer Investigational Site Kiel
Germany Pfizer Investigational Site Muenster
Germany Pfizer Investigational Site Regensburg
Norway Pfizer Investigational Site Oslo
Slovakia Pfizer Investigational Site Nitra
Spain Pfizer Investigational Site Barcelona
Spain Pfizer Investigational Site Barcelona
Spain Pfizer Investigational Site L'hospitalet Del Llobregat Barcelona
Spain Pfizer Investigational Site Madrid
Spain Pfizer Investigational Site Majadahonda Madrid

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

Belgium,  Czech Republic,  Denmark,  Germany,  Norway,  Slovakia,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety and toleration up to 12 weeks Yes
Primary Endoscopic score changes as calculated using section 3 of the Mayo Score up to 12 weeks No
Primary Disease activity score changes as calculated using the Mayo Score up to 12 weeks No
Secondary Plasma concentrations of PF-00547659 up to 12 weeks No
Secondary Fecal concentrations of calprotectin up to 12 weeks No
Secondary Plasma concentrations of CRP up to 12 weeks No
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