Long Term Safety Study of Tanezumab in Chronic Low Back Pain
NCT00924664
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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- Patient has completed the Preferred Rollover Time Point visit of the double blind CLBP parent study or has been withdrawn for lack of efficacy.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)
- 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- Withdrawn from a parent tanezumab double blind CLBP study for an adverse event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
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Descriptive Information | ||||
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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 |
| |||
Study Arms ICMJE |
| |||
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 | 849 | |||
Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
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 |
| |||
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 |