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Long Term Safety Study of Tanezumab in Chronic Low Back Pain

Last updated on March 15, 2019

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.
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- 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parent study or has been withdrawn for lack of efficacy.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.
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- 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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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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