Tanezumab In Osteoarthritis Of The Knee (2)

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00830063
First received: January 23, 2009
Last updated: June 7, 2011
Last verified: June 2011
  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 3

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Naproxen
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Gout Suppressants
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014