ClinicalTrials.gov record
A Phase 3 Study of Tanezumab for Chronic Low Back Pain
ClinicalTrials.gov ID: NCT02528253
Public ClinicalTrials.gov record NCT02528253. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO AND ACTIVE-CONTROLLED, MULTICENTER, PARALLEL-GROUP STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB IN ADULT SUBJECTS WITH CHRONIC LOW BACK PAIN
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will investigate the efficacy and safety of tanezumab 5 mg and 10 mg administered by subcutaneous injection seven times at 8 week intervals (56 weeks). The primary objective of this study is to evaluate the effectiveness of tanezumab 10 mg and 5 mg compared to placebo for the treatment of chronic low back pain. Secondary objectives are to evaluate the long-term safety and effectiveness of tanezumab 10 mg and 5 mg compared to placebo for the treatment of chronic low back pain. In addition, the study will evaluate the effectiveness and long term safety profile of tanezumab treatment for chronic low back pain compared to tramadol Prolonged Release (PR), a medication commonly utilized for the treatment of chronic low back pain.
Study identification
- NCT ID
- NCT02528253
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,832 participants
Conditions and interventions
Conditions
Interventions
- Placebo to Week 16; tanezumab 5mg SC Biological
- Placebo to Week 16, tanezumab 10 mg SC Biological
- Tanezumab 5 mg SC Biological
- Tanezumab 10 mg SC Biological
- Tramadol PR oral Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 17, 2015
- Primary completion
- Oct 16, 2017
- Completion
- Dec 19, 2018
- Last update posted
- Feb 20, 2020
2015 – 2018
United States locations
- U.S. sites
- 179
- U.S. states
- 39
- U.S. cities
- 127
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Central Alabama Research | Birmingham | Alabama | 35209 | — |
| Cahaba Research | Birmingham | Alabama | 35242 | — |
| Alabama Clinical Research, LLC | Mobile | Alabama | 36608 | — |
| Alabama Orthopaedic Clinic, P.C. | Mobile | Alabama | 36608 | — |
| Coastal Clinical Research | Mobile | Alabama | 36608 | — |
| Horizon Research Partners, LLC | Mobile | Alabama | 36608 | — |
| The Center for Clinical Trials, Inc. | Saraland | Alabama | 36571 | — |
| Ferguson Family Medicine | Mesa | Arizona | 85215 | — |
| The Pain Center of Arizona | Phoenix | Arizona | 85018 | — |
| Arizona Research Center | Phoenix | Arizona | 85053 | — |
| Valley Pain Consultants | Scottsdale | Arizona | 85254 | — |
| KLR Business Group dba Arkansas Clinical Research | Little Rock | Arkansas | 72205 | — |
| Lynn Institute of the Ozarks | Little Rock | Arkansas | 72205 | — |
| Primary Care of Arkansas, P.A. | Little Rock | Arkansas | 72205 | — |
| Anaheim Clinical Trials, LLC | Anaheim | California | 92801 | — |
| Core Healthcare Group | Cerritos | California | 90703 | — |
| eStudySite | Chula Vista | California | 91911 | — |
| Triwest Research Associates, LLC | El Cajon | California | 92020 | — |
| Research Center of Fresno, Inc. | Fresno | California | 93702 | — |
| Neuro-Pain Medical Center | Fresno | California | 93710 | — |
| Valley Research-Trials | Fresno | California | 93720 | — |
| Collaborative Neuroscience Network, LLC. | Garden Grove | California | 92845 | — |
| eStudySite | La Mesa | California | 91942 | — |
| Collaborative Neuroscience Network, LLC. | Long Beach | California | 90806 | — |
| University of Southern California | Los Angeles | California | 90033 | — |
| USC IDS Pharmacy | Los Angeles | California | 90033 | — |
| Catalina Research Institute, LLC | Montclair | California | 91763 | — |
| Providence Clinical Research | North Hollywood | California | 91606 | — |
| Northern California Research | Sacramento | California | 95821 | — |
| Artemis Institute for Clinical Research | San Diego | California | 92103 | — |
| Encompass Clinical Research | Spring Valley | California | 91978 | — |
| Bayview Research Group | Valley Village | California | 91607 | — |
| Diablo Clinical Research, Inc. | Walnut Creek | California | 94598 | — |
| Elite Clinical Trials, Inc. | Wildomar | California | 92595 | — |
| Alpine Clinical Research Center | Boulder | Colorado | 80301 | — |
| Mountain View Clinical Research, Inc. | Denver | Colorado | 80209 | — |
| Mountain View Clinical Research, Inc | Denver | Colorado | 80209 | — |
| New England Research Associates, LLC | Bridgeport | Connecticut | 06606 | — |
| My Health 1st Urgent Care | Milford | Connecticut | 06460 | — |
| Stamford Therapeutics Consortium | Stamford | Connecticut | 06905 | — |
| JEM Research Institute | Atlantis | Florida | 33462 | — |
| Orthopedic Research Institute | Boynton Beach | Florida | 33472 | — |
| Clinical Research of South Florida | Coral Gables | Florida | 33134 | — |
| Avail Clinical Research,LLC | DeLand | Florida | 32720 | — |
| Midland Florida Clinical Research Center, LLC | DeLand | Florida | 32720 | — |
| S&W Clinical Research | Fort Lauderdale | Florida | 33306 | — |
| MD Clinical | Hallandale | Florida | 33009 | — |
| Pines Clinical Research Inc. | Hollywood | Florida | 33024 | — |
| Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida | 32256 | — |
| Health Awareness, Inc. | Jupiter | Florida | 33458 | — |
| Columbus Clinical Services, LLC | Miami | Florida | 33125 | — |
| Larkin Imaging Center | Miami | Florida | 33173 | — |
| M & M Medical Center, Inc | Miami | Florida | 33185 | — |
| Quality Research & Medical Center LLC | Miami | Florida | 33186 | — |
| Crystal Biomedical Research, LLC | Miami Lakes | Florida | 33014 | — |
| Sensible Healthcare, LLC. | Ocoee | Florida | 34761 | — |
| Compass Research, LLC | Orlando | Florida | 32806 | — |
| National Pain Research Institute | Orlando | Florida | 32807 | — |
| Progressive Medical Research | Port Orange | Florida | 32127 | — |
| Gulfcoast Research Institute | Sarasota | Florida | 34232 | — |
| Meridien Research | St. Petersburg | Florida | 33709 | — |
| Meridien Research | Tampa | Florida | 33634 | — |
| Palm Beach Research Center | West Palm Beach | Florida | 33409 | — |
| River Birch Research Alliance, LLC | Blue Ridge | Georgia | 30513 | — |
| Columbus Regional Research Institute | Columbus | Georgia | 31904 | — |
| Center for Advanced Research & Education | Gainesville | Georgia | 30501 | — |
| Drug Studies America | Marietta | Georgia | 30060 | — |
| Georgia Institute for Clinical Research, LLC | Marietta | Georgia | 30060 | — |
| Non-Surgical Orthopaedics, P.C. | Marietta | Georgia | 30060 | — |
| Better Health Clinical Research Inc | Newnan | Georgia | 30265 | — |
| Better Health Clinical Research, Inc. | Newnan | Georgia | 30265 | — |
| Southeast Regional Research Group | Savannah | Georgia | 31401 | — |
| North Georgia Clinical Research | Woodstock | Georgia | 30189 | — |
| North Georgia Internal Medicine | Woodstock | Georgia | 30189 | — |
| East-West Medical Research Institute | Honolulu | Hawaii | 96814 | — |
| Medex Healthcare Research Inc | Chicago | Illinois | 60602 | — |
| Chicago Clinical Research Institute, Inc. | Chicago | Illinois | 60607 | — |
| Northwestern Memorial Hospital - Arkes Pavilion, Diagnostic Testing Center | Chicago | Illinois | 60611 | — |
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | — |
| Northwestern University, Feinberg School of Medicine, Lavin Pavilion | Chicago | Illinois | 60611 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Great Lakes Clinical Trials | Chicago | Illinois | 60640 | — |
| Chicago Anesthesia Pain Specialists | Chicago | Illinois | 60657 | — |
| Clinical Investigation Specialists, Inc. | Skokie | Illinois | 60076 | — |
| Investigators Research Group, LLC | Brownsburg | Indiana | 46112 | — |
| MediSphere Medical Research Center, LLC | Evansville | Indiana | 47714 | — |
| Lafayette Clinical Research Group | Lafayette | Indiana | 47905 | — |
| Lafayette Regional Vein and Laser Center | Lafayette | Indiana | 47905 | — |
| Buynak Clinical Research, P.C. | Valparaiso | Indiana | 46383 | — |
| The Iowa Clinic - Internal Medicine | Des Moines | Iowa | 50309 | — |
| The Iowa Clinic Medical Imaging | Des Moines | Iowa | 50309 | — |
| The Iowa Clinic | Des Moines | Iowa | 50309 | — |
| The Iowa Clinic Medical Imaging | West Des Moines | Iowa | 50266 | — |
| The Iowa Clinic | West Des Moines | Iowa | 50266 | — |
| Mid-America Physiatrists, P.A. | Overland Park | Kansas | 66210 | — |
| Professional Research Network of Kansas, LLC | Wichita | Kansas | 67205 | — |
| Mayfield Imaging Center | Crestview Hills | Kentucky | 41017 | — |
| Otri-Med Corporation | Edgewood | Kentucky | 41017 | — |
| St Elizabeth Hospital Edgewood | Edgewood | Kentucky | 41017 | — |
| Willis-Knighton Physician Network/ Spine and Pain Specialist | Bossier City | Louisiana | 71111 | — |
| Willis-Knighton Physician Network/WKB Family Medicine Associates | Bossier City | Louisiana | 71111 | — |
| Centex Studies, Inc | Lake Charles | Louisiana | 70601 | — |
| Best Clinical Trials, LLC | New Orleans | Louisiana | 70115 | — |
| George Stanley Walker, MD | New Orleans | Louisiana | 70115 | — |
| Klein & Associates, M.D., P.A. | Cumberland | Maryland | 21502 | — |
| The Center for Rheumatology and Bone Research | Wheaton | Maryland | 20902 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| Brigham and Women's Hospital | Chestnut Hill | Massachusetts | 02467 | — |
| Beacon Clinical Research, LLC | Quincy | Massachusetts | 02169 | — |
| MedVadis Research Corporation | Watertown | Massachusetts | 02472 | — |
| Great Lakes Research Group, Inc. | Bay City | Michigan | 48706 | — |
| Michigan Orthopaedic Spine Surgeons | Rochester Hills | Michigan | 48307 | — |
| Oakland Medical Research | Troy | Michigan | 48085 | — |
| Michigan Pain Consultants | Wyoming | Michigan | 49519 | — |
| CRC of Jackson, LLC | Jackson | Mississippi | 39202 | — |
| Physician's Surgery Center | Jackson | Mississippi | 39202 | — |
| Olive Branch Family Medical Center | Olive Branch | Mississippi | 38654 | — |
| Medex Healthcare Research, Inc. | St Louis | Missouri | 63117 | — |
| Heartland Clinical Research, Inc. | Omaha | Nebraska | 68134 | — |
| Affiliated Clinical Research, Inc. | Las Vegas | Nevada | 89106 | — |
| Office of Stephen H. Miller, MD | Las Vegas | Nevada | 89117 | — |
| Office of Robert Kaplan, DO | Las Vegas | Nevada | 89119 | — |
| Advanced Biomedical Research of America | Las Vegas | Nevada | 89123 | — |
| ActivMed Practices & Research, Inc. | Portsmouth | New Hampshire | 03801 | — |
| Comprehensive Clinical Research | Berlin | New Jersey | 08009 | — |
| CRI Worldwide, LLC | Marlton | New Jersey | 08053 | — |
| University Clinical Research Center | Somerset | New Jersey | 08873 | — |
| Premier Research | Trenton | New Jersey | 08611 | — |
| Albuquerque Clinical Trials, Inc. | Albuquerque | New Mexico | 87102 | — |
| New Mexico Clinical Research & Osteoporosis Center, Inc. | Albuquerque | New Mexico | 87106 | — |
| Healthwise Medical Associates | Brooklyn | New York | 11206 | — |
| Drug Trials America | Hartsdale | New York | 10530 | — |
| The Medical Research Network, LLC | New York | New York | 10128 | — |
| AAIR Research Center | Rochester | New York | 14618 | — |
| University of Rochester | Rochester | New York | 14618 | — |
| Northstate Clinical Research | Lenoir | North Carolina | 28645 | — |
| On Site Clinical Solutions, LLC | Mooresville | North Carolina | 28117 | — |
| Wake Research Associates, LLC | Raleigh | North Carolina | 27612 | — |
| PMG Research of Winston-Salem, LLC | Winston-Salem | North Carolina | 27103 | — |
| The Center for Clinical Research | Winston-Salem | North Carolina | 27103 | — |
| Lillestol Research, LLC | Fargo | North Dakota | 58104 | — |
| Plains Clinical Research Center, LLC | Fargo | North Dakota | 58104 | — |
| Heartland Diagnostics | Frgi | North Dakota | 58104 | — |
| Clinical Inquest Center Ltd | Beavercreek | Ohio | 45431 | — |
| Valley Medical Research/Valley Medical Primary Care | Centerville | Ohio | 45459 | — |
| Hightop Medical Research Center | Cincinnati | Ohio | 45224 | — |
| New Horizons Clinical Research | Cincinnati | Ohio | 45242 | — |
| Optimed Research LTD | Columbus | Ohio | 43235 | — |
| Prestige Clinical Research | Franklin | Ohio | 45005 | — |
| Great Lakes Medical Research, LLC | Mentor | Ohio | 44060 | — |
| Oaktree Clinic | Mentor | Ohio | 44060 | — |
| Bone Joint & Spine Surgeons, Inc. | Toledo | Ohio | 43623 | — |
| COR Clinical Research, L.L.C | Oklahoma City | Oklahoma | 73103 | — |
| Health Research of Oklahoma | Oklahoma City | Oklahoma | 73103 | — |
| NPC Research | Oklahoma City | Oklahoma | 73109 | — |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | — |
| Brandywine Clinical Research | Downingtown | Pennsylvania | 19335 | — |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | — |
| Omega Medical Research | Warwick | Rhode Island | 02886 | — |
| TLM Medical Services | Columbia | South Carolina | 29204 | — |
| DeGarmo Institute of Medical Research | Greer | South Carolina | 29650 | — |
| Lowcountry Orthopaedics & Sports Medicine | North Charleston | South Carolina | 29406 | — |
| Health Concepts | Rapid City | South Dakota | 57702 | — |
| PCET Research Center, LLC | Knoxville | Tennessee | 37909 | — |
| Quality Medical Research | Nashville | Tennessee | 37211 | — |
| KRK Medical Research | Arlington | Texas | 76012 | — |
| Advances In Health | Houston | Texas | 77030 | — |
| Centex Studies, Inc./Clear Lake Family Physicians | Houston | Texas | 77058 | — |
| Clinical Trial Network | Houston | Texas | 77074 | — |
| The Pain Relief Center | Plano | Texas | 75024 | — |
| Quality Research, Inc. | San Antonio | Texas | 78209 | — |
| Lee Medical Associates, PA | San Antonio | Texas | 78213 | — |
| Progressive Clinical Research, PA | San Antonio | Texas | 78213 | — |
| Physicians Research Options, LLC | Draper | Utah | 84020 | — |
| Charlottesville Medical Research Center, LLC | Charlottesville | Virginia | 22911 | — |
| Virginia Research Center | Midlothian | Virginia | 23114 | — |
| National Clinical Research - Richmond, Inc. | Richmond | Virginia | 23294 | — |
| Washington Center for Pain Management | Bellevue | Washington | 98004 | — |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 83 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02528253, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 20, 2020 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02528253 live on ClinicalTrials.gov.