A Study of Tanezumab in Adults With Chronic Low Back Pain
NCT ID: NCT00876187
Last Updated: 2021-07-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
1359 participants
INTERVENTIONAL
2009-06-15
2011-02-01
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
TRIPLE
Study Groups
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Tanezumab 20 mg IV
Tanezumab 20 mg IV
2 IV administrations of tanezumab 20 mg at an 8 week interval
Placebo for naproxen
Oral placebo for naproxen twice a day for 16 weeks
Tanezumab 10 mg IV
Tanezumab 10 mg IV
2 IV administrations of tanezumab 10 mg at an 8 week interval
Placebo for naproxen
Oral placebo for naproxen twice a day for 16 weeks
Tanezumab 5 mg IV
Tanezumab 5 mg IV
2 IV administrations of tanezumab 5 mg at an 8 week interval
Placebo for naproxen
Oral placebo for naproxen twice a day for 16 weeks
Naproxen
Placebo for tanezumab
2 IV administrations of placebo for tanezumab at an 8 week interval
Naproxen
Oral naproxen 500 mg twice a day for 16 weeks
Placebo
Placebo for tanezumab
2 IV administrations of placebo for tanezumab at an 8 week interval
Placebo for naproxen
Oral placebo for naproxen twice a day for 16 weeks
Interventions
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Tanezumab 20 mg IV
2 IV administrations of tanezumab 20 mg at an 8 week interval
Placebo for naproxen
Oral placebo for naproxen twice a day for 16 weeks
Tanezumab 10 mg IV
2 IV administrations of tanezumab 10 mg at an 8 week interval
Placebo for naproxen
Oral placebo for naproxen twice a day for 16 weeks
Tanezumab 5 mg IV
2 IV administrations of tanezumab 5 mg at an 8 week interval
Placebo for naproxen
Oral placebo for naproxen twice a day for 16 weeks
Placebo for tanezumab
2 IV administrations of placebo for tanezumab at an 8 week interval
Naproxen
Oral naproxen 500 mg twice a day for 16 weeks
Placebo for tanezumab
2 IV administrations of placebo for tanezumab at an 8 week interval
Placebo for naproxen
Oral placebo for naproxen twice a day for 16 weeks
Eligibility Criteria
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Inclusion Criteria
* Primary location of low back pain must be between the 12th thoracic vertebra and the lower gluteal folds, with or without radiation into the posterior thigh
* Must meet criteria for pain severity and global assessment of low back pain at Screening and Baseline visits
* Female patients of child-bearing potential (and male patients with female partners who are of child-bearing potential) must use 2 methods of contraception throughout the study
* Patients must be willing to discontinue all pain medications for chronic low back pain except rescue medication and not use prohibited pain medications throughout the duration of the study
Exclusion Criteria
* Back pain due to visceral disorder (eg, endometriosis).
* Back pain due to major trauma or osteoporotic compression fracture in the past 6 months.
* History of rheumatoid arthritis, seronegative spondyloarthropathy, Paget's disease of spine, pelvis or femur; fibromyalgia; tumors or infections of the spinal cord.
* Surgical intervention during the past 6 months for the treatment of low back pain or plans for surgical intervention during the course of the study.
* Current or pending worker's compensation, litigation, disability, or any other monetary settlement regarding his/her CLBP or any other pain condition, or any closed claim within the past 5 years.
* Use of any analgesic or muscle relaxant within 48 hours prior to the five days before Baseline
* Patients receiving only acetaminophen, gabapentin or pregabalin to manage their chronic low back pain.
* Patients taking \>325 mg/day of aspirin.
* Use of any antidepressants with the exception of stable treatment with selective serotonin reuptake inhibitors (SSRIs).
* Use of any sedatives/hypnotics, anxiolytics, tranquilizers, or benzodiazepines unless daily dose has been stable and will remain unchanged throughout the study period.
* Systemic corticosteroid therapy within 30 days (inhaled and topical corticosteroids are permitted).
* Local or epidural injection of corticosteroids, as well as injections of corticosteroids in the back within 3 months.
* Botulinum toxin (Botox®) injection for chronic low back pain within 4 months.
* Requirement for new, concomitant physiotherapy including, but not limited to, transdermal electroneural stimulation (TENS), massage or spinal manipulation for the duration of the study period.
* Active or suspected esophageal, gastric, pyloric channel, or duodenal ulceration within 3 months, or any history of gastrointestinal bleeding.
* Current use of lithium or anticoagulant agents.
* Known hypersensitivity or intolerance to NSAIDs; history of asthma, urticaria, or allergic type reactions after taking aspirin or NSAIDs.
* Inflammatory bowel disease, a chronic or acute renal or hepatic disorder, a significant coagulation defect, or other condition that might preclude the use of an NSAID.
* History of intolerance to acetaminophen or paracetamol or any of its excipients.
* History of known alcohol, analgesic or narcotic abuse within 2 years.
* Presence of drugs of abuse (including prescription medications without a valid prescription), other illegal drugs or marijuana in the urine toxicology screen obtained at Screening.
* History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG fusion protein.
* Use of biologics other than study medication, including any live vaccines, within 3 months, or use during the study (intranasal Flumist® vaccine is an exception).
* Signs and symptoms of clinically significant cardiac disease.
* Diagnosis of a transient ischemic attack within the 6 months, or residual deficits from stroke that would preclude completion of required study activities.
* History of cancer within 5 years.
* Use of any investigational medication within 30 days (3 months for investigational biologics).
* Expected to undergo a therapeutic procedure or to use any analgesic other than those specified in the protocol throughout the study period.
* Previous exposure to exogenous NGF or to an anti NGF antibody.
* Screening laboratory results and blood pressure within specified limits.
* Positive Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV) tests at screening.
* History, diagnosis, or signs and symptoms of clinically significant neurological disease.
* History, diagnosis, signs or symptoms of any clinically significant psychiatric disorder.
* Hospital admission for depression or suicide attempt within 5 years or active, severe major depression at Screening.
* Likelihood of being non compliant with study procedures.
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 LLC
Anniston, Alabama, United States
Pinnacle Research Group, LLC
Anniston, Alabama, United States
Simon Williamson Clinic, PC
Birmingham, Alabama, United States
Simon-Williamson Clinic, PC
Hueytown, Alabama, United States
Saadat Ansari, MD office
Huntsville, Alabama, United States
Horizon Research Group
Mobile, Alabama, United States
Radiant Research - Phoenix Southeast
Chandler, Arizona, United States
Pivotal Research Centers
Peoria, Arizona, United States
Arizona Research Center
Phoenix, Arizona, United States
Radiant Research, Inc.: Scottsdale, AZ
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
Alta Clinical Research, LLC
Tucson, 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
North County Clinical Research (NCCR)
Oceanside, California, United States
Advances in Medicine
Rancho Mirage, California, United States
Quality Control Research, Inc
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
Wildomar, California, United States
Alpine Clinical Research Center
Boulder, Colorado, United States
Clinicos, LLC
Colorado Springs, Colorado, 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 of Walton County
DeFuniak Springs, Florida, United States
Avail Clinical Research, LLC
DeLand, Florida, United States
SJS Clinical Research, Inc.
Destin, Florida, United States
CRIA Research
Fort Lauderdale, 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
University Clinical Research Incorporated
Pembroke Pines, Florida, United States
Advent Clinical Research Center
Pinellas Park, Florida, United States
Arthntis & Rheumatic Care Center
South Miami, Florida, United States
Miami Research Associates
South Miami, Florida, United States
Meridien Research
St. Petersburg, Florida, United States
Dale G. Bramlet, MD
St. Petersburg, Florida, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
Center for Prospective Outcome Studies
Atlanta, Georgia, United States
River Birch Research Alliance, LLC
Blue Ridge, Georgia, United States
Drug Studies America
Marietta, Georgia, United States
Selah Medical Center, PA
Boise, Idaho, United States
MediSphere Medical Research Center, LLC
Evansville, Indiana, United States
Vince and Associates Clinical Research
Overiand Park, Kansas, United States
Vince and Associates Clinical Research
Overland Park, Kansas, United States
Clinical Trials Technology, Inc.
Prairie Village, Kansas, United States
Cotton-O'Neil Clinical Research
Topeka, Kansas, United States
Central Kentucky Research Association, Inc.
Lexington, Kentucky, United States
Commonwealth Biomedical Research, LLC
Madisonville, Kentucky, United States
Arthritis and Diabetes Clinic
Monroe, Louisiana, United States
Peter A. Holt, MD
Baltimore, Maryland, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States
PCM Medical Services
Lansing, Michigan, 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
CRI Worldwide
Willingboro, New Jersey, United States
Albuquerque Clinical Trials
Albuquerque, New Mexico, United States
Central New York Clinical Research
Manlius, New York, United States
Medex Healthcare Research, Inc.
New York, New York, United States
Medex Healthcare Research
New York, New York, United States
The Medical Research Network, LLC
New York, New York, United States
Rochester Clinical Research
Rochester, New York, United States
Finger Lakes Clinical Research
Rochester, New York, United States
Upstate Clinical Research Associates
Williamsville, New York, United States
Pharmquest
Greensboro, 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
Community Research
Cincinnati, Ohio, United States
Sterling Research
Cincinnati, Ohio, 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
Oklahoma City, Oklahoma, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Sunstone Medical Research, LLC
Medford, Oregon, United States
Summit Research Network (Oregon), Inc.
Portland, Oregon, United States
Allegheny Pain Management
Altoona, Pennsylvania, United States
East Penn Rheumatology Associates, PC
Bethlehem, 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
Germantown, Tennessee, United States
Wolf River Medical Group, LLC
Germantown, Tennessee, United States
Advanced Therapeutics, Inc.
Johnson City, Tennessee, United States
Johnson City Internal Medicine
Johnson City, Tennessee, United States
Capitol Medical Clinic
Austin, Texas, United States
Walter F. Chase, MD, PA
Austin, Texas, United States
FutureSearch Trials of Neurology
Austin, Texas, United States
FutureSearch Trials
Austin, Texas, United States
DiscoveResearch, Inc.
Beaumont, Texas, United States
DiscoveResearch, Incorporated
Bryan, Texas, United States
Trinity Hypertension & Metabolic Research Institute Punzi Medical Center
Carrollton, Texas, United States
KRK Medical Research
Dallas, Texas, United States
Advances In Health, Inc.
Houston, Texas, United States
Centex Research, Inc.
Houston, Texas, United States
Centex Research
Houston, Texas, United States
Centex Research
Nassau Bay, Texas, United States
Office of Theresia Lee, MD
San Antonio, Texas, United States
Paragon Research Center
San Antonio, Texas, United States
Progressive Clinical Research, PA
San Antonio, Texas, United States
Foothill Family Clinic
Salt Lake City, Utah, United States
Foothill Family Clinic
Salt Lake City, Utah, United States
Charlottesville Medical Research
Charlottesville, Virginia, United States
National Clinical Research - Norfolk, Inc.
Norfolk, Virginia, United States
National Clinical Research, Incorporated
Richmond, 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.
Kivitz AJ, Gimbel JS, Bramson C, Nemeth MA, Keller DS, Brown MT, West CR, Verburg KM. Efficacy and safety of tanezumab versus naproxen in the treatment of chronic low back pain. Pain. 2013 Jul;154(7):1009-21. doi: 10.1016/j.pain.2013.03.006. Epub 2013 Mar 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-IV PH2B
Identifier Type: OTHER
Identifier Source: secondary_id
A4091012
Identifier Type: -
Identifier Source: org_study_id
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