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
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:
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 April 17, 2014