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Tanezumab In Osteoarthritis Of The Hip Or Knee

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00985621
First received: September 25, 2009
Last updated: August 23, 2012
Last verified: August 2012
  Purpose

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


Condition Intervention Phase
Osteoarthritis
Biological: tanezumab 10 mg
Biological: tanezumab 5 mg
Drug: oxycodone
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 Oxycodone-Controlled, Multicenter Study Of The Efficacy And Safety Of Tanezumab In Patients With Osteoarthritis Of The Knee Or Hip

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • WOMAC pain [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • WOMAC Pain [ Time Frame: Weeks 2, 4, 12 and 16 ] [ Designated as safety issue: No ]
  • WOMAC Physical Function [ 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 index [ Time Frame: Weeks 2, 4, 8, 12, and 16 ] [ Designated as safety issue: No ]
  • Reduction in the WOMAC Pain subscale of greater than or equal to 30/50/70/90% [ Time Frame: Weeks 2, 4, 8, 12, and 16 ] [ Designated as safety issue: No ]
  • Cumulative distribution of percent change from Baseline in the WOMAC Pain subscale score [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Improvement of ≥2 points in Patient Global Assessment of Osteoarthritis [ Time Frame: Week 2, 4, 8, 12, and 16 ] [ Designated as safety issue: No ]
  • Average daily NRS pain score in the index knee or index hip change from Baseline [ Time Frame: Weeks 2, 4, 8, 12, and 16 ] [ Designated as safety issue: No ]
  • WOMAC Stiffness subscale change from Baseline [ Time Frame: Weeks 2, 4, 8, 12, and 16 ] [ Designated as safety issue: No ]
  • WOMAC Average change from Baseline [ Time Frame: Weeks 2, 4, 8, 12, and 16 ] [ Designated as safety issue: No ]
  • SF-36 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • EQ-5D [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Safety (AEs, laboratory, ECGs, PEs, vital signs, neurological exam) [ Time Frame: All Weeks ] [ Designated as safety issue: Yes ]

Enrollment: 600
Study Start Date: October 2009
Study Completion Date: December 2010
Primary Completion Date: December 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: oxycodone
oxycodone CR, 10-40 mg q12h
Placebo Comparator: 4 Other: placebo
placebo

Detailed Description:

This study was terminated on 13 Dec 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • osteoarthritis of the knee or hip 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
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: NCT00985621

  Show 99 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00985621     History of Changes
Other Study ID Numbers: A4091030
Study First Received: September 25, 2009
Last Updated: August 23, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
monoclonal antibody
RN624
PF-04383119
nerve growth factor
OA
pain
arthritis

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Oxycodone
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014