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Trial record 1 of 1 for:    NCT00863772
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Tanezumab and Nerve Function In Arthritis Patients

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: NCT00863772
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : March 18, 2009
Last Update Posted : August 29, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE March 17, 2009
First Posted Date  ICMJE March 18, 2009
Last Update Posted Date August 29, 2012
Study Start Date  ICMJE May 2009
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 17, 2009)
Change from Baseline in the composite measure (5NC [nd] + HRdb [nd]) [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2009)
  • Intraepidermal nerve fiber density [ Time Frame: 6 months ]
  • WOMAC subscales [ Time Frame: 6 months ]
  • Patient's Global Assessment of Arthritis [ Time Frame: 6 months ]
  • Tanezumab levels in the plasma [ Time Frame: 6 months ]
  • Anti-tanezumab antibodies in the serum [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tanezumab and Nerve Function In Arthritis Patients
Official Title  ICMJE A Phase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter Study Of Tanezumab On Peripheral Nerve Function In Patients With Osteoarthritis
Brief Summary Tanezumab reduces pain of osteoarthritis without affecting how nerve impulses are transmitted in sensory nerves.
Detailed Description This study was terminated on 16 Nov 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE
  • Biological: tanezumab
    5 mg dose Intravenously every 8 weeks for duration of study
  • Biological: tanezumab
    10 mg dose Intravenously every 8 weeks for duration of study
  • Other: Placebo
    Placebo, Intravenously, every 8 weeks for duration of study
Study Arms  ICMJE
  • Experimental: Tanezumab 5 mg
    Intervention: Biological: tanezumab
  • Experimental: Tanezumab 10 mg
    Intervention: Biological: tanezumab
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 16, 2010)
220
Original Estimated Enrollment  ICMJE
 (submitted: March 17, 2009)
369
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • BMI less or equal to 39 kg/m2
  • Osteoarthritis (arthritis) of the knee or hip with pain score that qualifies
  • Willing to comply with study visit schedule and study requirements, including, for women of child-bearing potential or male patients with female partners of child-bearing potential, the use of 2 forms of birth control, one of which is a barrier method.
  • Patients must consent in writing to participate in the study.

Exclusion Criteria:

  • Untreated, uncontrolled diseases,
  • Unwilling or unable to discontinue the use of prohibited medications, including other pain medications, during the screening period and during the study,
  • Significant cardiac disease within the past 6 months
  • Significant neurological disease (e.g. peripheral neuropathy, multiple sclerosis, stroke) or signs of neuropathy at screening
  • Known bleeding disorder or anticoagulation therapy
  • Planned surgery during the study period
  • History of alcoholism or drug abuse in the past 2 years
  • Unable to use acetaminophen
  • Use of a biologic (including live vaccines, with the exception of Flumist) within the past 3 months
  • Allergic reaction to a biologic or an antibody in the past
  • Disqualifying laboratory values, including Hepatitis B or C, HIV or drug test
  • Cancer in the past 5 years. Basal cell or squamous cell carcinoma are okay.
  • Medical condition that may interfere with study endpoints or safety of the subject as determined by the investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Canada,   United States
 
Administrative Information
NCT Number  ICMJE NCT00863772
Other Study ID Numbers  ICMJE A4091026
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP