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A Long Term Study of the Safety of Tanezumab When Administered By Subcutaneous Injections

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ClinicalTrials.gov Identifier: NCT00994890
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : October 14, 2009
Last Update Posted : October 5, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE October 12, 2009
First Posted Date  ICMJE October 14, 2009
Last Update Posted Date October 5, 2012
Study Start Date  ICMJE November 2009
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 13, 2009)
  • Adverse events [ Time Frame: Baseline to Week 64 ]
  • Safety laboratory testing [ Time Frame: Day 1, Weeks 8, 16, 24, 40, 56 and 64 ]
  • Electrocardiograms (ECGs) [ Time Frame: Baseline, Weeks 2, 8, 24 and 56 ]
  • Neurologic examinations, Vital Signs and Injection Site Assessments [ Time Frame: Baseline, Weeks 2, 4 ,8, 16, 24, 32, 40, 48, 56 and 64 ]
  • Anti-drug antibody concentrations [ Time Frame: Baseline, Weeks 8, 24, 40, 56 and 64 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00994890 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2009)
  • WOMAC Pain [ Time Frame: Baseline , Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 ]
  • WOMAC Physical Function [ Time Frame: Baseline , Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 ]
  • WOMAC Stiffness [ Time Frame: Baseline , Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 ]
  • Patient Global Assessment of Osteoarthritis [ Time Frame: Baseline , Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 ]
  • OMERACT-OARSI Responder Index [ Time Frame: Baseline , Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 ]
  • Treatment Response: Reduction in WOMAC Pain [ Time Frame: Baseline , Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 ]
  • Cumulative Distribution of Percent Change in WOMAC Pain [ Time Frame: Baseline , Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 ]
  • Treatment Response in Patient Global Assessment of Osteoarthritis [ Time Frame: Baseline , Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 ]
  • WOMAC Average Score [ Time Frame: Baseline , Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 ]
  • WOMAC Pain Item: Pain When Walking on Flat Surface [ Time Frame: Baseline , Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 ]
  • WOMAC Pain Item: Pain When Going up or Down Stairs [ Time Frame: Baseline , Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 ]
  • Time to discontinuation Due to Lack of Efficacy [ Time Frame: Baseline to Week 64 ]
  • Incidence of patients who use concomitant analgesics for osteoarthritis [ Time Frame: Baseline , Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 ]
  • Number of days per week of use of concomitant analgesic medication for osteoarthritis [ Time Frame: Baseline , Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 ]
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 A Long Term Study of the Safety of Tanezumab When Administered By Subcutaneous Injections
Official Title  ICMJE A Multicenter, Randomized, Double-Blind, Long Term Study Of The Safety Of Subcutaneous Administration Of Tanezumab In Patients With Osteoarthritis Of The Knee Or Hip
Brief Summary This study will investigate the safety of three fixed dose levels of tanezumab (2.5 mg, 5 mg, and 10 mg) administered at an 8-week interval by subcutaneous injection multiple (7) times during the study treatment period.
Detailed Description Safety study of tanezumab in relief of osteoarthritis pain This study was terminated on 6 December 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 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE
  • Osteoarthritis, Knee
  • Osteoarthritis, Hip
Intervention  ICMJE
  • Biological: Tanezumab 2.5 mg
    Tanezumab 2.5 mg administered by subcutaneous injection every 8 weeks for a total of 7 injections administered over approximately 1 year
    Other Name: Biological
  • Biological: Tanezumab 5 mg
    Tanezumab 5 mg administered by subcutaneous injection every 8 weeks for a total of 7 injections administered over approximately 1 year
    Other Name: Biological
  • Biological: Tanezumab 10 mg
    Tanezumab 10 mg administered by subcutaneous injection every 8 weeks for a total of 7 injections administered over approximately 1 year
    Other Name: Biological
Study Arms  ICMJE
  • Experimental: Tanezumab 2.5 mg
    Intervention: Biological: Tanezumab 2.5 mg
  • Experimental: Tanezumab 5 mg
    Intervention: Biological: Tanezumab 5 mg
  • Experimental: Tanezumab 10 mg
    Intervention: Biological: Tanezumab 10 mg
Publications * Not Provided

*   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)
679
Original Estimated Enrollment  ICMJE
 (submitted: October 13, 2009)
600
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Osteoarthritis of the knee or hip based on American College of Rheumatology criteria with a radiographic (X ray) confirmation (a Kellgren Lawrence x-ray grade of ≥2);

Exclusion Criteria:

  • Body mass index (BMI) of >39 kg/m2;
  • Pregnancy or intent to become pregnant
  • Planned surgical procedure during the duration of the study
  • History of clinically significant cardiovascular, central nervous system or psychiatric disease
  • Previous exposure to exogenous NGF or to an anti NGF antibody;
  • Use of biologics other than study medication, Live or live-attenuated intranasal vaccines (eg, Flumist), are allowable exceptions
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 United States
 
Administrative Information
NCT Number  ICMJE NCT00994890
Other Study ID Numbers  ICMJE A4091043
Has Data Monitoring Committee Yes
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 October 2012

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