Long Term Safety Study of Tanezumab in Chronic Low Back Pain

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00924664
First received: June 18, 2009
Last updated: August 23, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Low Back Pain
Biological: Tanezumab 20 mg
Biological: Tanezumab 10 mg
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Long Term Study of the Safety of Tanezumab in Patients With Chronic Low Back Pain

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Adverse events; Injection site assessments; Safety laboratory testing; Electrocardiogram; Neurological examination; Anti-drug antibody assessments; Physical examinations; Vital signs. [ Time Frame: 64 weeks ] [ Designated as safety issue: Yes ]
  • Change from Baseline to various time points throughout the study in the Brief Pain Inventory Short Form (BPI sf) pain scores, Pain Interference with Function Composite Score, and Pain Interference subscales. [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]
  • Roland Morris Disability Questionnaire (RMDQ) total score, Patient Global Assessment of Low Back Pain, and Work Productivity and Activity Impairment Questionnaire total score change from Baseline to various time points throughout the study. [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]
  • Time to discontinuation due to lack of efficacy. [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]
  • Use of concomitant analgesic medication for CLBP. [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics of tanezumab and NGF assay [ Time Frame: 64 weeks ] [ Designated as safety issue: No ]

Enrollment: 849
Study Start Date: August 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tanezumab 20 mg 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
Experimental: Tanezumab 10 mg 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00924664

  Show 106 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00924664     History of Changes
Other Study ID Numbers: A4091039
Study First Received: June 18, 2009
Last Updated: August 23, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
low back pain monoclonal antibody nerve growth factor

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 18, 2014