Long Term Safety Study of Tanezumab in Chronic Low Back Pain

Pfizer

Status and phase

Terminated

Phase 2

Conditions

Low Back Pain

Treatments

Biological: Tanezumab 10 mg

Biological: Tanezumab 20 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT00924664

A4091039

CLBP SAFETY EXTENSION OF 1012 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

849 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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