Clinical trial NCT00924664: Long Term Safety Study of Tanezumab in Chronic Low Back Pain
Official title: A RANDOMIZED, MULTICENTER, LONG TERM STUDY OF THE SAFETY OF TANEZUMAB IN PATIENTS WITH CHRONIC LOW BACK PAIN
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Low Back Pain
Keywords: low back pain monoclonal antibody nerve growth factor
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-06-19
Enrollment: 849
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to 112 days after last dose of study treatment (up to 448 days)
measure: Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 4
timeFrame: A4091012: Baseline, A4091039: Week 4
measure: Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 8
timeFrame: A4091012: Baseline, A4091039: Week 8
measure: Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 16
timeFrame: A4091012: Baseline, A4091039: Week 16
measure: Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 24
timeFrame: A4091012: Baseline, A4091039: Week 24
measure: Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 32
timeFrame: A4091012: Baseline, A4091039: Week 32
measure: Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 40
timeFrame: A4091012: Baseline, A4091039: Week 40
measure: Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 48
timeFrame: A4091012: Baseline, A4091039: Week 48
measure: Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 56
timeFrame: A4091012: Baseline, A4091039: Week 56
measure: Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 4
timeFrame: A4091012: Baseline, A4091039: Week 4
measure: Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 8
timeFrame: A4091012: Baseline, A4091039: Week 8
measure: Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 16
timeFrame: A4091012: Baseline, A4091039: Week 16
measure: Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 24
timeFrame: A4091012: Baseline, A4091039: Week 24
measure: Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 32
timeFrame: A4091012: Baseline, A4091039: Week 32
measure: Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 40
timeFrame: A4091012: Baseline, A4091039: Week 40
measure: Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 48
timeFrame: A4091012: Baseline, A4091039: Week 48
measure: Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 56
timeFrame: A4091012: Baseline, A4091039: Week 56
measure: Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 4
timeFrame: A4091012: Baseline, A4091039: Week 4
measure: Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 8
timeFrame: A4091012: Baseline, A4091039: Week 8
measure: Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 16
timeFrame: A4091012: Baseline, A4091039: Week 16
measure: Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 24
timeFrame: A4091012: Baseline, A4091039: Week 24
measure: Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 32
timeFrame: A4091012: Baseline, A4091039: Week 32
measure: Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 40
timeFrame: A4091012: Baseline, A4091039: Week 40
measure: Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 48
timeFrame: A4091012: Baseline, A4091039: Week 48
measure: Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 56
timeFrame: A4091012: Baseline, A4091039: Week 56
measure: Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 4
timeFrame: A4091012: Baseline, A4091039: Week 4
measure: Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 8
timeFrame: A4091012: Baseline, A4091039: Week 8
measure: Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 16
timeFrame: A4091012: Baseline, A4091039: Week 16
measure: Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 24
timeFrame: A4091012: Baseline, A4091039: Week 24
measure: Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 32
timeFrame: A4091012: Baseline, A4091039: Week 32
measure: Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 40
timeFrame: A4091012: Baseline, A4091039: Week 40
measure: Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 48
timeFrame: A4091012: Baseline, A4091039: Week 48
measure: Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 56
timeFrame: A4091012: Baseline, A4091039: Week 56
measure: Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 4
timeFrame: A4091012: Baseline, A4091039: Week 4
measure: Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 8
timeFrame: A4091012: Baseline, A4091039: Week 8
measure: Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 16
timeFrame: A4091012: Baseline, A4091039: Week 16
measure: Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 24
timeFrame: A4091012: Baseline, A4091039: Week 24
measure: Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 32
timeFrame: A4091012: Baseline, A4091039: Week 32
measure: Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 40
timeFrame: A4091012: Baseline, A4091039: Week 40
measure: Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 48
timeFrame: A4091012: Baseline, A4091039: Week 48
measure: Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 56
timeFrame: A4091012: Baseline, A4091039: Week 56
Secondary outcomes:
measure: Time to Discontinuation Due to Lack of Efficacy
timeFrame: Baseline up to Week 56
measure: Plasma Concentration of Tanezumab
timeFrame: Baseline (Day 1), Week 8, 24, 40, 56, 64
measure: Total Nerve Growth Factor (NGF) Concentration
timeFrame: Baseline (Day 1), Week 8, 24, 40, 56, 64
Other outcomes:
measure: Number of Participants Using Concomitant Medication for Chronic Low Back Pain (CLBP)
timeFrame: Baseline up to Week 56
measure: Change From A4091012 (NCT00876187) Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 24 and 56
timeFrame: A4091012: Baseline, A4091039: Week 24, 56
measure: Number of Participants Who Developed Anti-Tanezumab Antibodies
timeFrame: Baseline (Day 1), Week 8, 24, 40, 56, 64
measure: Number of Participants With Injection and Infusion Site Reactions
timeFrame: Baseline (Day 1), Week 4, 8, 16, 24, 32 for intravenous infusion; Week 24, 32, 40, 56, 64 for subcutaneous injection
measure: Number of Participants With Intravenous and Subcutaneous Doses of Study Medication
timeFrame: Day 1 up to Week 56
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group, LLC
state: Alabama
city: Anniston
country: United States
facility: Pinnacle Research Group, Anniston Medical Clinic
state: Alabama
city: Anniston
country: United States
facility: Pinnacle Research Group
state: Alabama
city: Birmingham
country: United States
facility: Simon Williamson Clinic, PC
state: Alabama
city: Hueytown
country: United States
facility: Simon-Williamson Clinic, PC
state: Alabama
city: Huntsville
country: United States
facility: Saadat Ansari, MD
state: Alabama
city: Mobile
country: United States
facility: Alabama Orthopaedic Clinic
state: Alabama
city: Mobile
country: United States
facility: Horizon Research Group
state: Alabama
city: Chandler
country: United States
facility: Phoenix Diagnostic Imaging
state: Arizona
city: Chandler
country: United States
facility: Radiant Research - Phoenix Southeast
state: Arizona
city: Mesa
country: United States
facility: Simon Med
state: Arizona
city: Peoria
country: United States
facility: Pivotal Research Centers
state: Arizona
city: Peoria
country: United States
facility: Sun Radiology
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center, LLC
state: Arizona
city: Scottsdale
country: United States
facility: Radiant Research
state: Arizona
city: Scottsdale
country: United States
facility: Scottsdale Medical Imaging
state: Arizona
city: Tempe
country: United States
facility: Premiere Phamaceutical Research, LLC
state: Arizona
city: Tempe
country: United States
facility: Clinical Research Advantage, Inc./Fiel Family and Sports Medicine, PC
state: Arizona
city: Little Rock
country: United States
facility: Little Rock Family Practice Clinic
state: Arkansas
city: Burbank
country: United States
facility: Providence Clinical Research
state: California
city: Fresno
country: United States
facility: Valley Research
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network, Inc.
state: California
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Los Gatos
country: United States
facility: Samaritan Center for Medical Research Medical Group
state: California
city: Newport Beach
country: United States
facility: Newport Diagnostic Center
state: California
city: Oceanside
country: United States
facility: North County Clinical Research (NCCR)
state: California
city: Rancho Mirage
country: United States
facility: Advances in Medicine
state: California
city: Roseville
country: United States
facility: Trinity Medical Research
state: California
city: Sacramento
country: United States
facility: Center for Clinical Trials of Sacramento, Inc.
state: California
city: San Diego
country: United States
facility: Wetlin Research Associates, Inc
state: California
city: Upland
country: United States
facility: Inland Rheumatology & Osteoporosis Medical Group, Inc.
state: California
city: Wildomar
country: United States
facility: Elite Clinical Trials, Inc.
state: California
city: Boulder
country: United States
facility: Alpine Clinical Research Center
state: Colorado
city: Colorado Springs
country: United States
facility: Clinicos, LLC
state: Colorado
city: Stamford
country: United States
facility: Advanced Radiology
state: Connecticut
city: Stamford
country: United States
facility: Stamford Therapeutics Consortium
state: Connecticut
city: Trumbull
country: United States
facility: New England Research Associates, LLC
state: Connecticut
city: Chiefland
country: United States
facility: Southeast Clinical Research, LLC
state: Florida
city: Chiefland
country: United States
facility: Southeast Clinical Research
state: Florida
city: DeFuniak Springs
country: United States
facility: Doctors Medical Center
state: Florida
city: DeLand
country: United States
facility: Avail Clinical Research, LLC
state: Florida
city: Destin
country: United States
facility: SJS Clinical Research, Inc.
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Southeast Clinical Research, LLC
state: Florida
city: Naples
country: United States
facility: Collier Neurologic Specialists
state: Florida
city: Orlando
country: United States
facility: Compass Research, LLC
state: Florida
city: Palm Beach Gardens
country: United States
facility: Palm Beach Gardens Open Imaging Center
state: Florida
city: Pembroke Pines
country: United States
facility: University Clinical Research
state: Florida
city: Pinellas Park
country: United States
facility: Advent Clinical Research Center
state: Florida
city: Saint Petersburg
country: United States
facility: Meridien Research
state: Florida
city: Saint Petersburg
country: United States
facility: St Petersburg General Hospital - X-Rays only
state: Florida
city: Saint Petersburg
country: United States
facility: Dale G. Bramlet, MD., P.L.
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: West Palm Beach
country: United States
facility: MD Now Urgent Care
state: Florida
city: West Palm Beach
country: United States
facility: Midtown Imaging
state: Florida
city: Atlanta
country: United States
facility: Center for Prospective Outcome Studies
state: Georgia
city: Atlanta
country: United States
facility: Southeastern Radiology Associates, LLC
state: Georgia
city: Blue Ridge
country: United States
facility: River Birch Research Alliance, LLC
state: Georgia
city: Marietta
country: United States
facility: CT: Marietta Imaging Center LLC
state: Georgia
city: Marietta
country: United States
facility: Drug Studies America
state: Georgia
city: Boise
country: United States
facility: Selah Medical Center, PA
state: Idaho
city: Evansville
country: United States
facility: Advanced Diagnostic Imaging (ADI)
state: Indiana
city: Evansville
country: United States
facility: MediSphere Medical Research Center, LLC
state: Indiana
city: Overland Park
country: United States
facility: Diagnostic Imaging Centers
state: Kansas
city: Prairie Village
country: United States
facility: Clinical Trials Technology, Inc.
state: Kansas
city: Topeka
country: United States
facility: Cotton-O'Neil Clinical Research Center
state: Kansas
city: Topeka
country: United States
facility: Cotton-O'Neil Clinic
state: Kansas
city: Lexington
country: United States
facility: Central Kentucky Research Associates, Inc.
state: Kentucky
city: Madisonville
country: United States
facility: Commonwealth Biomedical Research
state: Kentucky
city: Monroe
country: United States
facility: Arthritis and Diabetes Clinic
state: Louisiana
city: Baltimore
country: United States
facility: Office of Peter A. Holt, MD
state: Maryland
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: Biloxi
country: United States
facility: The Center for Clinical Trials
state: Mississippi
city: Jackson
country: United States
facility: Clinical Research Center of Jackson
state: Mississippi
city: Jackson
country: United States
facility: Physician's Surgery Center
state: Mississippi
city: Saint Louis
country: United States
facility: Medex Healthcare Research, Inc.
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Health Research
state: Missouri
city: Springfield
country: United States
facility: Clinvest, A Division of Banyan Group, Inc
state: Missouri
city: Omaha
country: United States
facility: Quality Clinical Research, Inc.
state: Nebraska
city: Omaha
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Las Vegas
country: United States
facility: Clinical Research Consortium
state: Nevada
city: Las Vegas
country: United States
facility: Mirkil Medical
state: Nevada
city: Las Vegas
country: United States
facility: Advanced Biomedical Research of America
state: Nevada
city: Berlin
country: United States
facility: Comprehensive Clinical Research
state: New Jersey
city: Stratford
country: United States
facility: Booth Radiology
state: New Jersey
city: Willingboro
country: United States
facility: CRI Worldwide, LLC
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials, Inc.
state: New Mexico
city: Manlius
country: United States
facility: Central New York Clinical Research
state: New York
city: New York
country: United States
facility: Medex Healthcare Research
state: New York
city: New York
country: United States
facility: The Medical Research Network, LLC
state: New York
city: Rochester
country: United States
facility: B & I Imaging
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc.
state: New York
city: Rochester
country: United States
facility: Finger Lakes Clinical Research
state: New York
city: Williamsville
country: United States
facility: Upstate Clinical Research Associates
state: New York
city: Greensboro
country: United States
facility: Greensboro Imaging
state: North Carolina
city: Greensboro
country: United States
facility: Pharmquest
state: North Carolina
city: Lenoir
country: United States
facility: Caldwell Memorial Hospital
state: North Carolina
city: Lenoir
country: United States
facility: Northstate Clinical Research, PLLC
state: North Carolina
city: Raleigh
country: United States
facility: Wake Internal Medicine Consultants, Inc.
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: The Center for Clinical Research
state: North Carolina
city: Cleveland
country: United States
facility: Rapid Medical Research, Inc.
state: Ohio
city: Oklahoma City
country: United States
facility: Christine Codding, MD
state: Oklahoma
city: Oklahoma City
country: United States
facility: Health Research of Oklahoma
state: Oklahoma
city: Oklahoma City
country: United States
facility: McBride Clinic, Inc
state: Oklahoma
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Medford
country: United States
facility: Medford Medical Clinic, LLP
state: Oregon
city: Medford
country: United States
facility: Rogue Valley Medical Center
state: Oregon
city: Medford
country: United States
facility: Sunstone Research
state: Oregon
city: Portland
country: United States
facility: Summit Research Network (Oregon), Inc.
state: Oregon
city: Altoona
country: United States
facility: Allegheny Pain Management
state: Pennsylvania
city: Altoona
country: United States
facility: Blair Medical Associates-Radiology
state: Pennsylvania
city: Bridgeville
country: United States
facility: Paramount Clinical Research
state: Pennsylvania
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Philadelphia
country: United States
facility: CRI Worldwide LLC
state: Pennsylvania
city: Cranston
country: United States
facility: New England Center for Clinical Research
state: Rhode Island
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Columbia
country: United States
facility: Columbia Arthritis Center, P.A.
state: South Carolina
city: Columbia
country: United States
facility: Southern Orthopaedic Sports Medicine
state: South Carolina
city: Greer
country: United States
facility: Radiant Research
state: South Carolina
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Germantown
country: United States
facility: SCRI Research Center, LLC
state: Tennessee
city: Germantown
country: United States
facility: Wolf River Medical Group, LLC
state: Tennessee
city: Johnson City
country: United States
facility: Advanced Therapeutics, Inc.
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials of Neurology
state: Texas
city: Beaumont
country: United States
facility: DiscoveResearch, Inc.
state: Texas
city: Beaumont
country: United States
facility: Beaumont Internal Medicine & Geriatric Associates
state: Texas
city: Bryan
country: United States
facility: DiscoveResearch Incorporated
state: Texas
city: Carrollton
country: United States
facility: Punzi Medical Center
state: Texas
city: Dallas
country: United States
facility: KRK Medical Research
state: Texas
city: Houston
country: United States
facility: Advances In Health, Inc.
state: Texas
city: Houston
country: United States
facility: St. Luke's Diagnostic & Treatment Center Kirby Glen
state: Texas
city: Houston
country: United States
facility: Centex Research Inc.
state: Texas
city: Houston
country: United States
facility: Centex Research
state: Texas
city: Nassau Bay
country: United States
facility: Centex Research
state: Texas
city: San Antonio
country: United States
facility: Paragon Research Center
state: Texas
city: San Antonio
country: United States
facility: Office of Theresia Lee, MD
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Sendero Imaging and Treatment Center
state: Texas
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc.
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Incorporated/Foothill Family Clinic South
state: Utah
city: Charlottesville
country: United States
facility: Charlottesville Medical Research
state: Virginia
city: Norfolk
country: United States
facility: Chesapeake Regional Imaging Center-Kempsville
state: Virginia
city: Norfolk
country: United States
facility: Hampton Road Center for Clinical Research
state: Virginia
city: Richmond
country: United States
facility: National Clinical Research - Richmond
state: Virginia
city: Virginia Beach
country: United States
facility: Virginia Beach Radiology
state: Virginia
city: Virginia Beach
country: United States
facility: Advanced Pain Management
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Hochberg MC, Tive LA, Abramson SB, Vignon E, Verburg KM, West CR, Smith MD, Hungerford DS. When Is Osteonecrosis Not Osteonecrosis?: Adjudication of Reported Serious Adverse Joint Events in the Tanezumab Clinical Development Program. Arthritis Rheumatol. 2016 Feb;68(2):382-91. doi: 10.1002/art.39492.
citation: Gimbel JS, Kivitz AJ, Bramson C, Nemeth MA, Keller DS, Brown MT, West CR, Verburg KM. Long-term safety and effectiveness of tanezumab as treatment for chronic low back pain. Pain. 2014 Sep;155(9):1793-1801. doi: 10.1016/j.pain.2014.06.004. Epub 2014 Jun 14.