Tanezumab in Osteoarthritis of the Knee - Full Text View

Sponsors and Collaborators:	Pfizer PharmaNet
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00733902

Purpose

Test the efficacy and safety of 3 doses in Osteoarthritis of the knee in patients.

Condition	Intervention	Phase
Arthritis Osteoarthritis	Biological: tanezumab Biological: Placebo	Phase III

MedlinePlus related topics: Osteoarthritis

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 3 Randomized, Double Blind, Placebo-Controlled Multicenter Study Of The Analgesic Efficacy And Safety Of Tanezumab In Patients With Osteoarthritis Of The Knee

Further study details as provided by Pfizer:

Primary Outcome Measures:

WOMAC function [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
WOMAC pain [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
Patient Global Assessment of Osteoarthritis [ Time Frame: Week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Womac pain, physical function and stiffness at other timepoints [ Time Frame: Weeks 2, 4, 8, 12, 16 and 32 ] [ Designated as safety issue: No ]
SF-36 [ Time Frame: Weeks 12 and 24 ] [ Designated as safety issue: No ]
Daily NRS scores [ Time Frame: daily to Week 32 ] [ Designated as safety issue: No ]
Safety (AEs, laboratory, ECGs, physical exam, vital signs) [ Time Frame: All weeks ] [ Designated as safety issue: Yes ]
Time to discontinuation [ Time Frame: All weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	600
Study Start Date:	November 2008
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Tanezumab 10 mg: Experimental	Biological: tanezumab IV tanezumab 10 mg at 1 dose every 8 weeks
Tanezumab 5 mg: Experimental	Biological: tanezumab IV tanezumab 5 mg at 1 dose every 8 weeks
Tanezumab 2.5 mg: Experimental	Biological: tanezumab IV tanezumab 2.5 mg at 1 dose every 8 weeks
Placebo: Placebo Comparator	Biological: Placebo IV placebo to match tanezumab at 1 dose every 8 weeks

Eligibility

Criteria

Inclusion Criteria:

Osteoarthritis of the knee according to ACR criteria with a Kellgren-Lawrence x-ray grade of 2.
Unwilling or unable to take non-opiate pain medications, for whom non-opiate pain medications have not provided adequate pain relief or are candidates for knee injections arthroplasty or replace surgery.
Pain level and function levels as required by the protocol at Screening and Baseline.
Willing to discontinue pain medications (acetaminophen will be permitted up to a certain level) before and during the study.
Must agree to the contraceptive requirements of the protocol if applicable.
Must agree to the treatment plan, scheduled visits, and procedures of the protocol.

Exclusion Criteria:

Pregnancy or intent to become pregnant during the study
BMI greater than 39
other severe pain, significant cardiac, neurological or psychological conditions, or above the protocol limits for laboratory and blood pressure results

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00733902

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Sponsors and Collaborators

Pfizer

PharmaNet

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A4091011
Study First Received:	August 11, 2008
Last Updated:	April 2, 2009
ClinicalTrials.gov Identifier:	NCT00733902 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

monoclonal antibody, RN624, PF-04383119, nerve growth factor, anti-nerve growth factor, OA, pain

Study placed in the following topic categories:

Antibodies, Monoclonal
Osteoarthritis, Knee
Antibodies
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases

Arthritis
Mitogens
Pain
Analgesics
Rheumatic Diseases
Immunoglobulins

Additional relevant MeSH terms:

Osteoarthritis, Knee
Musculoskeletal Diseases
Osteoarthritis

Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 07, 2009