Safety Extension Study Of Tanezumab When Administered By Subcutaneous Injection To Patients With Osteoarthritis

NCT01127893

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Osteoarthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Must have participated in specific Phase 3 parent study

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Failed screening for parent study, pregnant women, lactating mothers

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Advanced Information
Descriptive Information
Brief Title  ICMJE Safety Extension Study Of Tanezumab When Administered By Subcutaneous Injection To Patients With Osteoarthritis
Official Title  ICMJE A Phase 3, Multicenter, Randomized, Long Term Study Of The Safety Of The Subcutaneous Administration Of Tanezumab In Patients With Osteoarthritis Of The Knee
Brief Summary An evaluation of the long term safety of tanezumab when administered by subcutaneous injection every 8 weeks for up to 64 weeks
Detailed Description This study was terminated on 29 September 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
    Tanezumab 10 mg administered by subcutaneous injection every 8 weeks for up to 7 injections
  • Biological: Tanezumab
    Tanezumab 5 mg administered by subcutaneous injection every 8 weeks for up to 7 injections
  • Biological: Tanezumab
    Tanezumab 2.5 mg administered by subcutaneous injection every 8 weeks for up to 7 injections
Study Arms  ICMJE
  • Experimental: Tanezumab 10 mg
    Intervention: Biological: Tanezumab
  • Experimental: Tanezumab 5 mg
    Intervention: Biological: Tanezumab
  • Experimental: Tanezumab 2.5 mg
    Intervention: Biological: Tanezumab
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)
1
Original Estimated Enrollment  ICMJE
 (submitted: May 20, 2010)
510
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Must have participated in specific Phase 3 parent study

Exclusion Criteria:

  • Failed screening for parent study, pregnant women, lactating mothers
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 NCT01127893
Other Study ID Numbers  ICMJE A4091032
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 CenterPfizer
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