Tanezumab in Osteoarthritis of the Hip - Full Text View

Purpose

The purpose of this study is to test the efficacy and safety of 3 doses of tanezumab in osteoarthritis of the hip in patients

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

MedlinePlus related topics:

Osteoarthritis

Drug Information available for:

Nerve growth factor

U.S. FDA Resources

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 Hip

Further study details as provided by Pfizer:

Primary Outcome Measures:

Womac Function [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Womac Pain [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Patient Global Assessment of Arthritis [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Womac pain, physical function and stiffness [ 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 ]
Safety (laboratory, ECGs, vitals) [ Time Frame: all weeks ] [ Designated as safety issue: Yes ]
Time to discontinuations [ Time Frame: all weeks ] [ Designated as safety issue: No ]
Daily NRS scores [ Time Frame: daily to Week 32 ] [ Designated as safety issue: No ]

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

Arms	Assigned Interventions
Tanezumab 10 mg: Experimental Tanezumab 10 mg IV every 8 weeks	Biological: tanezumab Tanezumab 10 mg IV every 8 weeks
Tanezumab 5 mg: Experimental Tanezumab 5mg IV every 8 weeks	Biological: tanezumab Tanezumab 5mg IV every 8 weeks
Tanezumab 2.5 mg: Experimental Tanezumab 2.5 mg IV every 8 weeks.	Biological: tanezumab Tanezumab 2.5 mg IV every 8 weeks.
Placebo: Experimental Placebo	Biological: Placebo Placebo to match tanezumab IV every 8 weeks

Eligibility

Criteria

Inclusion Criteria:

Osteoarthritis of the hip according to ACR criteria with 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 Hip injections, arthroplasty or replacement surgery
Pain level and fuction 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
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: NCT00744471

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

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A4091014
First Received:	August 29, 2008
Last Updated:	October 14, 2008
ClinicalTrials.gov Identifier:	NCT00744471
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

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

Study placed in the following topic categories:

Antibodies, Monoclonal

Antibodies

Musculoskeletal Diseases

Osteoarthritis

Joint Diseases

Arthritis

Rheumatic Diseases

Osteoarthritis, Hip

ClinicalTrials.gov processed this record on October 24, 2008

Sponsors and Collaborators:	Pfizer PharmaNet
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00744471