Tanezumab In Osteoarthritis Of The Knee (2) - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00830063

Purpose

The purpose of this study is to test the efficacy and safety of 2 doses of tanezumab compared with naproxen and placebo in patients with osteoarthritis.

Condition	Intervention	Phase
Arthritis Osteoarthritis	Biological: tanezumab 10 mg Biological: tanezumab 5 mg Drug: naproxen Other: placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase 3 Randomized, Double Blind Placebo And Naproxen Controlled Multicenter Study Of The Analgesic Efficacy And Safety Of Tanezumab In Patients With Osteoarthritis Of The Knee

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Naproxen Naproxen sodium

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

WOMAC function [ Time Frame: weeks 12 and 16 ] [ Designated as safety issue: No ]
WOMAC pain [ Time Frame: weeks 12 and 16 ] [ Designated as safety issue: No ]
Patient Global Assessment of Osteoarthritis [ Time Frame: weeks 12 and 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Womac physical function [ Time Frame: weeks 2, 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
Womac pain [ Time Frame: weeks 2, 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
Patient Global Assessment of Osteoarthritis [ Time Frame: weeks 2, 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
OMERACT-OARSI responder criteria [ Time Frame: weeks 2, 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
SF-36 [ Time Frame: weeks 12 and 16 ] [ Designated as safety issue: No ]
Daily NRS scores [ Time Frame: weeks 2, 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
Safety (AEs, laboratory, ECGs, PEs, vital signs) [ Time Frame: all weeks ] [ Designated as safety issue: Yes ]
Time to discontinuation [ Time Frame: all weeks ] [ Designated as safety issue: No ]
Womac stiffness [ Time Frame: weeks 2, 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
Treatment Response: Reduction in the WOMAC Pain subscale [ Time Frame: weeks 2, 4, 8, 12 and 16 ] [ Designated as safety issue: No ]

Enrollment:	848
Study Start Date:	May 2009
Study Completion Date:	July 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Biological: tanezumab 10 mg tanezumab 10 mg one dose at weeks 0 and 8
Experimental: 2	Biological: tanezumab 5 mg tanezumab 5 mg one dose at weeks 0 and 8
Active Comparator: 3	Drug: naproxen naproxen 1000 mg daily for 16 weeks
Placebo Comparator: 4	Other: placebo placebo to match tanezumab and naproxen dosing

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Osteoarthritis of the knee according to Kellgren-Lawrence x-ray grade of 2

Exclusion Criteria:

Pregnancy or intent to become pregnant
BMI greater than 39
other severe pain, significant cardiac, neurologic or cardiac disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00830063

Show 85 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

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

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00830063 History of Changes
Other Study ID Numbers:	A4091015
Study First Received:	January 23, 2009
Last Updated:	June 7, 2011
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

Additional relevant MeSH terms:

Arthritis
Osteoarthritis
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012