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Long Term Safety Study of Tanezumab in Chronic Low Back Pain

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Anniston, Alabama, 36207 United States
Contact
1-800-718-1021
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parent study or has been withdrawn for lack of efficacy.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

NCT00924664
Pfizer
Terminated
Long Term Safety Study of Tanezumab in Chronic Low Back Pain

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Long Term Safety Study of Tanezumab in Chronic Low Back Pain
A Randomized, Multicenter, Long Term Study of the Safety of Tanezumab in Patients With Chronic Low Back Pain
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.
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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Low Back Pain
  • 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
  • Experimental: Tanezumab 20 mg
    Intervention: Biological: Tanezumab 20 mg
  • Experimental: Tanezumab 10 mg
    Intervention: Biological: Tanezumab 10 mg


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
849
November 2010
November 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00924664
A4091039
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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