We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Tanezumab In Osteoarthritis Of The Hip Or Knee

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00985621
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : September 28, 2009
Last Update Posted : August 30, 2012
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Osteoarthritis Biological: tanezumab 10 mg Biological: tanezumab 5 mg Drug: oxycodone Other: placebo Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : October 2009
Primary Completion Date : December 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Oxycodone
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. WOMAC pain [ Time Frame: Week 8 ]

Secondary Outcome Measures :
  1. WOMAC Pain [ Time Frame: Weeks 2, 4, 12 and 16 ]
  2. WOMAC Physical Function [ Time Frame: Weeks 2, 4, 8, 12, and 16 ]
  3. Patient Global Assessment of Osteoarthritis [ Time Frame: Weeks 2, 4, 8, 12, and 16 ]
  4. OMERACT OARSI responder index [ Time Frame: Weeks 2, 4, 8, 12, and 16 ]
  5. 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 ]
  6. Cumulative distribution of percent change from Baseline in the WOMAC Pain subscale score [ Time Frame: Week 16 ]
  7. Improvement of ≥2 points in Patient Global Assessment of Osteoarthritis [ Time Frame: Week 2, 4, 8, 12, and 16 ]
  8. Average daily NRS pain score in the index knee or index hip change from Baseline [ Time Frame: Weeks 2, 4, 8, 12, and 16 ]
  9. WOMAC Stiffness subscale change from Baseline [ Time Frame: Weeks 2, 4, 8, 12, and 16 ]
  10. WOMAC Average change from Baseline [ Time Frame: Weeks 2, 4, 8, 12, and 16 ]
  11. SF-36 [ Time Frame: Week 12 ]
  12. EQ-5D [ Time Frame: Week 12 ]
  13. Safety (AEs, laboratory, ECGs, PEs, vital signs, neurological exam) [ Time Frame: All Weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00985621

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

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00985621     History of Changes
Other Study ID Numbers: A4091030
First Posted: September 28, 2009    Key Record Dates
Last Update Posted: August 30, 2012
Last Verified: August 2012

Keywords provided by Pfizer:
monoclonal antibody
nerve growth factor

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents