Tanezumab in Osteoarthritis of the Hip or Knee (2) - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00863304

Purpose

Test the efficacy and safety of 2 doses of tanezumab compared with naproxen and placebo in patients with osteoarthritis

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 3 Randomized, Double Blind Placebo And Naproxen Controlled Multicenter Study of the Analgesic Efficacy And Study of Tanezumab in Patients With Osteoarthritis Of The Hip or 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 WOMAC Pain Subscale [ Time Frame: weeks 2, 4, 8, 12 and 16 ] [ Designated as safety issue: No ]

Estimated Enrollment:	800
Study Start Date:	May 2009
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Biological: tanezumab 10 mg tanezumab 10 mg one dose at weeks 0 and 8
2: Experimental	Biological: tanezumab 5 mg tanezumab 5 mg one dose at weeks 0 and 8
3: Active Comparator	Drug: naproxen naproxen 1000 mg daily for 16 weeks
4: Placebo Comparator	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 hip or 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, neurological or psychiatric disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00863304

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Show 73 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:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A4091018
Study First Received:	March 13, 2009
Last Updated:	January 25, 2010
ClinicalTrials.gov Identifier:	NCT00863304 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 arthritis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Naproxen
Molecular Mechanisms of Pharmacological Action
Osteoarthritis
Joint Diseases
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Enzyme Inhibitors
Osteoarthritis, Hip
Rheumatic Diseases
Gout Suppressants

Pharmacologic Actions
Musculoskeletal Diseases
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Arthritis
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010