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

Purpose

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

Condition	Intervention	Phase
Colitis, Ulcerative	Biological: Single dose-group A Biological: Multiple dose- Group B Biological: Multiple dose-Group B	Phase 1

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

Resource links provided by NLM:

Genetics Home Reference related topics: ulcerative colitis

MedlinePlus related topics: Ulcerative Colitis

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Safety and toleration [ Time Frame: up to 12 weeks ] [ Designated as safety issue: Yes ]
Endoscopic score changes as calculated using section 3 of the Mayo Score [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
Disease activity score changes as calculated using the Mayo Score [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Plasma concentrations of PF-00547659 [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
Fecal concentrations of calprotectin [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
Plasma concentrations of CRP [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	80
Study Start Date:	September 2005
Study Completion Date:	October 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
0.03 mg/kg or placebo iv	Biological: Single dose-group A PF-00547659, single iv dose
0.1 mg/kg or placebo iv	Biological: Single dose-group A PF-00547659, single iv dose Biological: Multiple dose- Group B PF-00547659, multiple dose
0.3 mg/kg or placebo iv	Biological: Single dose-group A PF-00547659, single iv 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 dose
3.0 mg/kg or placebo sc	Biological: Single dose-group A PF-00547659, single dose
10 mg/kg or placebo iv	Biological: Single dose-group A PF-00547659, single dose
0.3 mg/kg or placebo sc	Biological: Single dose-group A PF-00547659, single dose Biological: Multiple dose-Group B PF-00547659, multiple dose
0.1 mg/kg or placebo iv (multiple dose)	Biological: Multiple dose- Group B PF-00547659, multiple dose
0.3 mg/kg or placebo iv (multiple dose)	Biological: Multiple dose- Group B PF-00547659, multiple dose
3.0 mg/kg or placebo iv	Biological: Multiple dose- Group B PF-00547659, multiple dose
0.1 mg/kg or placebo sc	Biological: Multiple dose- Group B PF-00547659, multiple dose
0.3 mg/kg or placebo sc (multiple dose)	Biological: Multiple dose-Group B PF-00547659, multiple dose

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00928681

Locations

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

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00928681 History of Changes
Other Study ID Numbers:	A7281001
Study First Received:	June 22, 2009
Last Updated:	June 25, 2009
Health Authority:	Germany: Bfarm

Additional relevant MeSH terms:

Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases

Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013