Long Term Safety Study of Tanezumab in Chronic Low Back Pain
NCT ID: NCT00924664
Last Updated: 2021-04-21
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
849 participants
INTERVENTIONAL
2009-08-20
2011-06-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Tanezumab 20 mg
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
Tanezumab 10 mg
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pinnacle Research Group, LLC
Anniston, Alabama, United States
Pinnacle Research Group, Anniston Medical Clinic
Anniston, Alabama, United States
Pinnacle Research Group
Anniston, Alabama, United States
Simon Williamson Clinic, PC
Birmingham, Alabama, United States
Simon-Williamson Clinic, PC
Hueytown, Alabama, United States
Saadat Ansari, MD
Huntsville, Alabama, United States
Alabama Orthopaedic Clinic
Mobile, Alabama, United States
Horizon Research Group
Mobile, Alabama, United States
Phoenix Diagnostic Imaging
Chandler, Arizona, United States
Radiant Research - Phoenix Southeast
Chandler, Arizona, United States
Simon Med
Mesa, Arizona, United States
Pivotal Research Centers
Peoria, Arizona, United States
Sun Radiology
Peoria, Arizona, United States
Arizona Research Center, LLC
Phoenix, Arizona, United States
Radiant Research
Scottsdale, Arizona, United States
Scottsdale Medical Imaging
Scottsdale, Arizona, United States
Premiere Phamaceutical Research, LLC
Tempe, Arizona, United States
Clinical Research Advantage, Inc./Fiel Family and Sports Medicine, PC
Tempe, Arizona, United States
Little Rock Family Practice Clinic
Little Rock, Arkansas, United States
Providence Clinical Research
Burbank, California, United States
Valley Research
Fresno, California, United States
Collaborative Neuroscience Network, Inc.
Garden Grove, California, United States
University of California San Diego
La Jolla, California, United States
Samaritan Center for Medical Research Medical Group
Los Gatos, California, United States
Newport Diagnostic Center
Newport Beach, California, United States
North County Clinical Research (NCCR)
Oceanside, California, United States
Advances in Medicine
Rancho Mirage, California, United States
Trinity Medical Research
Roseville, California, United States
Center for Clinical Trials of Sacramento, Inc.
Sacramento, California, United States
Wetlin Research Associates, Inc
San Diego, California, United States
Inland Rheumatology & Osteoporosis Medical Group, Inc.
Upland, California, United States
Elite Clinical Trials, Inc.
Wildomar, California, United States
Alpine Clinical Research Center
Boulder, Colorado, United States
Clinicos, LLC
Colorado Springs, Colorado, United States
Advanced Radiology
Stamford, Connecticut, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, United States
New England Research Associates, LLC
Trumbull, Connecticut, United States
Southeast Clinical Research, LLC
Chiefland, Florida, United States
Southeast Clinical Research
Chiefland, Florida, United States
Doctors Medical Center
DeFuniak Springs, Florida, United States
Avail Clinical Research, LLC
DeLand, Florida, United States
SJS Clinical Research, Inc.
Destin, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Southeast Clinical Research, LLC
Jacksonville, Florida, United States
Collier Neurologic Specialists
Naples, Florida, United States
Compass Research, LLC
Orlando, Florida, United States
Palm Beach Gardens Open Imaging Center
Palm Beach Gardens, Florida, United States
University Clinical Research
Pembroke Pines, Florida, United States
Advent Clinical Research Center
Pinellas Park, Florida, United States
Miami Research Associates
South Miami, Florida, United States
Meridien Research
St. Petersburg, Florida, United States
St Petersburg General Hospital - X-Rays only
St. Petersburg, Florida, United States
Dale G. Bramlet, MD., P.L.
St. Petersburg, Florida, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
MD Now Urgent Care
West Palm Beach, Florida, United States
Midtown Imaging
West Palm Beach, Florida, United States
Center for Prospective Outcome Studies
Atlanta, Georgia, United States
Southeastern Radiology Associates, LLC
Atlanta, Georgia, United States
River Birch Research Alliance, LLC
Blue Ridge, Georgia, United States
CT: Marietta Imaging Center LLC
Marietta, Georgia, United States
Drug Studies America
Marietta, Georgia, United States
Selah Medical Center, PA
Boise, Idaho, United States
Advanced Diagnostic Imaging (ADI)
Evansville, Indiana, United States
MediSphere Medical Research Center, LLC
Evansville, Indiana, United States
Diagnostic Imaging Centers
Overland Park, Kansas, United States
Clinical Trials Technology, Inc.
Prairie Village, Kansas, United States
Cotton-O'Neil Clinical Research Center
Topeka, Kansas, United States
Cotton-O'Neil Clinic
Topeka, Kansas, United States
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, United States
Commonwealth Biomedical Research
Madisonville, Kentucky, United States
Arthritis and Diabetes Clinic
Monroe, Louisiana, United States
Office of Peter A. Holt, MD
Baltimore, Maryland, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States
The Center for Clinical Trials
Biloxi, Mississippi, United States
Clinical Research Center of Jackson
Jackson, Mississippi, United States
Physician's Surgery Center
Jackson, Mississippi, United States
Clinvest, A Division of Banyan Group, Inc
Springfield, Missouri, United States
Medex Healthcare Research, Inc.
St Louis, Missouri, United States
Mercy Health Research
St Louis, Missouri, United States
Quality Clinical Research, Inc.
Omaha, Nebraska, United States
Meridian Clinical Research, LLC
Omaha, Nebraska, United States
Clinical Research Consortium
Las Vegas, Nevada, United States
Mirkil Medical
Las Vegas, Nevada, United States
Advanced Biomedical Research of America
Las Vegas, Nevada, United States
Comprehensive Clinical Research
Berlin, New Jersey, United States
Booth Radiology
Stratford, New Jersey, United States
CRI Worldwide, LLC
Willingboro, New Jersey, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, United States
Central New York Clinical Research
Manlius, New York, United States
Medex Healthcare Research
New York, New York, United States
The Medical Research Network, LLC
New York, New York, United States
B & I Imaging
Rochester, New York, United States
Rochester Clinical Research, Inc.
Rochester, New York, United States
Finger Lakes Clinical Research
Rochester, New York, United States
Upstate Clinical Research Associates
Williamsville, New York, United States
Greensboro Imaging
Greensboro, North Carolina, United States
Pharmquest
Greensboro, North Carolina, United States
Caldwell Memorial Hospital
Lenoir, North Carolina, United States
Northstate Clinical Research, PLLC
Lenoir, North Carolina, United States
Wake Internal Medicine Consultants, Inc.
Raleigh, North Carolina, United States
Wake Research Associates, LLC
Raleigh, North Carolina, United States
The Center for Clinical Research
Winston-Salem, North Carolina, United States
Rapid Medical Research, Inc.
Cleveland, Ohio, United States
Christine Codding, MD
Oklahoma City, Oklahoma, United States
Health Research of Oklahoma
Oklahoma City, Oklahoma, United States
McBride Clinic, Inc
Oklahoma City, Oklahoma, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Medford Medical Clinic, LLP
Medford, Oregon, United States
Rogue Valley Medical Center
Medford, Oregon, United States
Sunstone Research
Medford, Oregon, United States
Summit Research Network (Oregon), Inc.
Portland, Oregon, United States
Allegheny Pain Management
Altoona, Pennsylvania, United States
Blair Medical Associates-Radiology
Altoona, Pennsylvania, United States
Paramount Clinical Research
Bridgeville, Pennsylvania, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
CRI Worldwide LLC
Philadelphia, Pennsylvania, United States
New England Center for Clinical Research
Cranston, Rhode Island, United States
Omega Medical Research
Warwick, Rhode Island, United States
Columbia Arthritis Center, P.A.
Columbia, South Carolina, United States
Southern Orthopaedic Sports Medicine
Columbia, South Carolina, United States
Radiant Research
Greer, South Carolina, United States
Health Concepts
Rapid City, South Dakota, United States
SCRI Research Center, LLC
Germantown, Tennessee, United States
Wolf River Medical Group, LLC
Germantown, Tennessee, United States
Advanced Therapeutics, Inc.
Johnson City, Tennessee, United States
FutureSearch Trials of Neurology
Austin, Texas, United States
DiscoveResearch, Inc.
Beaumont, Texas, United States
Beaumont Internal Medicine & Geriatric Associates
Beaumont, Texas, United States
DiscoveResearch Incorporated
Bryan, Texas, United States
Punzi Medical Center
Carrollton, Texas, United States
KRK Medical Research
Dallas, Texas, United States
Advances In Health, Inc.
Houston, Texas, United States
St. Luke's Diagnostic & Treatment Center Kirby Glen
Houston, Texas, United States
Centex Research Inc.
Houston, Texas, United States
Centex Research
Houston, Texas, United States
Centex Research
Nassau Bay, Texas, United States
Paragon Research Center
San Antonio, Texas, United States
Office of Theresia Lee, MD
San Antonio, Texas, United States
Progressive Clinical Research
San Antonio, Texas, United States
Sendero Imaging and Treatment Center
San Antonio, Texas, United States
J. Lewis Research, Inc.
Salt Lake City, Utah, United States
J. Lewis Research, Incorporated/Foothill Family Clinic South
Salt Lake City, Utah, United States
Charlottesville Medical Research
Charlottesville, Virginia, United States
Chesapeake Regional Imaging Center-Kempsville
Norfolk, Virginia, United States
Hampton Road Center for Clinical Research
Norfolk, Virginia, United States
National Clinical Research - Richmond
Richmond, Virginia, United States
Virginia Beach Radiology
Virginia Beach, Virginia, United States
Advanced Pain Management
Virginia Beach, Virginia, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Countries
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References
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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.
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.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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CLBP SAFETY EXTENSION OF 1012
Identifier Type: OTHER
Identifier Source: secondary_id
A4091039
Identifier Type: -
Identifier Source: org_study_id
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