Long Term Safety Study of Tanezumab in Chronic Low Back Pain

NCT00924664

Last updated date
Study Location
Pfizer Investigational Site
Anniston, Alabama, 36207, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

By email

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Low Back Pain
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

- Written informed consent prior to completing any of the study procedures.

- Female patients must meet one of the following criteria:

1) Female patients of non childbearing potential - Must be post menopausal, defined as women who are >=45 years old with amenorrhea for 24 consecutive months (regardless of FSH levels), or women who are amenorrheic for at least 1 year AND have a serum Follicle Stimulating Hormone (FSH) level greater than 30 IU/L at Screening for the parent double blind CLBP study; or Must be surgically sterile, defined as having had a hysterectomy and/or bilateral oophorectomy.

2.) Female patients of child bearing potential: must not be pregnant or lactating, and must be abstinent or use adequate contraception (2 forms of birth control, one of which must be a barrier method), and must have a negative serum pregnancy test at Screening (within 30 days prior to Baseline) and a negative urine pregnancy test at Baseline prior to initial dosing

- Male patients must agree that they and their female spouses / partners will use adequate contraception (2 forms of birth control, one of which must be barrier method) or be of non childbearing potential.

- Females of child bearing potential and males must be willing to use approved methods of contraception from commencement of screening procedures until 16 weeks after the last dose of IV study medication.

- Patient must be able to comply with lifestyle guidelines, scheduled visits, treatment plan, laboratory tests, and other study procedures

- Patient has been treated in a parent tanezumab double blind CLBP study

- Patient has completed the Preferred Rollover Time Point visit of the double blind CLBP parent study or has been withdrawn for lack of efficacy. At least eight weeks but no more than 12 weeks have elapsed since the last study medication infusion in the parent study. Patients are permitted to enter the extension study up to 12 weeks after their last dose of study medication in their parent study (or 4 weeks after the End of Treatment visit)

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


- Failed screening in a parent tanezumab double blind CLBP study


- Withdrawn from a parent tanezumab double blind CLBP study for an adverse event


- Pregnant women, lactating mothers, women suspected of being pregnant, and women who
wish to become pregnant during the course of clinical study


- Use of any investigational medication within 30 days prior to Baseline (3 months for
any investigational biological other than tanezumab) or plans to receive an
investigational medication other than the study medication during the course of this
study


- Patients who exited the parent double blind CLBP study because of lack of compliance,
protocol violation (including not meeting entrance criteria), no longer willing to
participate (for reasons other than lack of efficacy), or were lost to follow up in
the parent double blind study


- Patients who were randomized into the parent study in violation of inclusion or
exclusion criteria but who were not withdrawn from the parent study;


- Any other condition, which in the opinion of the Investigator, would put the patient
at increased safety risk or otherwise make the patient unsuitable for this study

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

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[email protected]

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Advanced Information
Descriptive Information
Brief Title  ICMJE Long Term Safety Study of Tanezumab in Chronic Low Back Pain
Official Title  ICMJE A Randomized, Multicenter, Long Term Study of the Safety of Tanezumab in Patients With Chronic Low Back Pain
Brief Summary The purpose of this study is to investigate the safety and efficacy of tanezumab for chronic low back pain. Patients who were randomized and treated with study medication in a previous chronic low back pain "parent" study will be eligible to enroll in this safety extension study at the Preferred Rollover Time Point visit or at the Early Termination visit of the parent study upon discontinuation due to lack of efficacy.
Detailed Description This study was terminated on 30 November 2010 following a US FDA clinical hold for tanezumab chronic low back pain clinical studies which halted dosing and enrollment of patients on 19 July 2010 for potential safety issues.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Low Back Pain
Intervention  ICMJE
  • Biological: Tanezumab 20 mg
    Tanezumab 20 mg administered IV every 8 weeks for 3 administrations followed by SC administration every 8 weeks for 4 administrations over a period of 64 weeks
  • Biological: Tanezumab 10 mg
    Tanezumab 10 mg administered IV every 8 weeks for 3 administrations followed by SC administration every 8 weeks for 4 administrations over a period of 64 weeks
Study Arms  ICMJE
  • Experimental: Tanezumab 20 mg
    Intervention: Biological: Tanezumab 20 mg
  • Experimental: Tanezumab 10 mg
    Intervention: Biological: Tanezumab 10 mg
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: August 23, 2012)
849
Original Estimated Enrollment  ICMJE
 (submitted: June 18, 2009)
2500
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:

  • Written informed consent prior to completing any of the study procedures.
  • Female patients must meet one of the following criteria:

    1) Female patients of non childbearing potential - Must be post menopausal, defined as women who are >=45 years old with amenorrhea for 24 consecutive months (regardless of FSH levels), or women who are amenorrheic for at least 1 year AND have a serum Follicle Stimulating Hormone (FSH) level greater than 30 IU/L at Screening for the parent double blind CLBP study; or Must be surgically sterile, defined as having had a hysterectomy and/or bilateral oophorectomy.

    2.) Female patients of child bearing potential: must not be pregnant or lactating, and must be abstinent or use adequate contraception (2 forms of birth control, one of which must be a barrier method), and must have a negative serum pregnancy test at Screening (within 30 days prior to Baseline) and a negative urine pregnancy test at Baseline prior to initial dosing

  • Male patients must agree that they and their female spouses / partners will use adequate contraception (2 forms of birth control, one of which must be barrier method) or be of non childbearing potential.
  • Females of child bearing potential and males must be willing to use approved methods of contraception from commencement of screening procedures until 16 weeks after the last dose of IV study medication.
  • Patient must be able to comply with lifestyle guidelines, scheduled visits, treatment plan, laboratory tests, and other study procedures
  • Patient has been treated in a parent tanezumab double blind CLBP study
  • Patient has completed the Preferred Rollover Time Point visit of the double blind CLBP parent study or has been withdrawn for lack of efficacy. At least eight weeks but no more than 12 weeks have elapsed since the last study medication infusion in the parent study. Patients are permitted to enter the extension study up to 12 weeks after their last dose of study medication in their parent study (or 4 weeks after the End of Treatment visit)

Exclusion Criteria:

  • Failed screening in a parent tanezumab double blind CLBP study
  • Withdrawn from a parent tanezumab double blind CLBP study for an adverse event
  • Pregnant women, lactating mothers, women suspected of being pregnant, and women who wish to become pregnant during the course of clinical study
  • Use of any investigational medication within 30 days prior to Baseline (3 months for any investigational biological other than tanezumab) or plans to receive an investigational medication other than the study medication during the course of this study
  • Patients who exited the parent double blind CLBP study because of lack of compliance, protocol violation (including not meeting entrance criteria), no longer willing to participate (for reasons other than lack of efficacy), or were lost to follow up in the parent double blind study
  • Patients who were randomized into the parent study in violation of inclusion or exclusion criteria but who were not withdrawn from the parent study;
  • Any other condition, which in the opinion of the Investigator, would put the patient at increased safety risk or otherwise make the patient unsuitable for this study
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00924664
Other Study ID Numbers  ICMJE A4091039
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 August 2012

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