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A Phase 3 Study of Tanezumab for Chronic Low Back Pain (TANGO)
This study is currently recruiting participants.
Verified July 2017 by Pfizer
Sponsor:
Pfizer
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT02528253
First received: August 11, 2015
Last updated: July 7, 2017
Last verified: July 2017
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Low Back Pain | Biological: 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 | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Participant, Care Provider, Investigator, Outcomes Assessor Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Change from Baseline in Daily average Low Back Pain Intensity (LBPI) Score [ Time Frame: Week 16 ]Change from Baseline to Week 16 in the daily average Low Back Pain Intensity (LBPI) score as measured by an 11 point Numeric Rating Scale for tanezumab vs placebo
Secondary Outcome Measures:
- Roland Morris Disability Questionnaire (RMDQ) [ Time Frame: Week 16 ]Change from Baseline to Week 16 in the Roland Morris Disability Questionnaire (RMDQ) for tanezumab vs placebo
- Change from Baseline in Daily average Low Back Pain Intensity (LBPI) Score [ Time Frame: Week 16 ]Change from Baseline to Week 16 in the daily average LBPI score as measured by an 11 point Numeric Rating Scale for tanezumab vs tramadol PR.
- Change from Baseline in Daily average Low Back Pain Intensity (LBPI) Score [ Time Frame: Weeks 2, 4, 8, 12, 24, 32, 40, 48, 56, and 64 ]Change from Baseline to Weeks 2, 4, 8, 12, 24, 32, 40, 48, 56, and 64 in average LBPI score
- Roland Morris Disability Questionnaire (RMDQ) [ Time Frame: Weeks 2, 4, 8, 16 (for tanezumab vs tramadol) 24, 32, 40, 48, 56, 64 and 80 ]Change from Baseline to Weeks 2, 4, 8, 16 (for tanezumab vs tramadol) 24, 32, 40, 48, 56, 64 and 80 in RMDQ total score
- Patient's Global Assessment of Low Back Pain [ Time Frame: Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, and 64 ]Change from Baseline to Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, and 64 in Patient's Global Assessment of Low Back Pain
- Cumulative distribution of percent change from Baseline in average Low Back Pain Intensity (LBPI) score [ Time Frame: Weeks 16, 24, and 56 ]Cumulative distribution of percent change from Baseline in average LBPI score to Weeks 16, 24, and 56 (endpoint for summary only)
- Pain Intensity Response [ Time Frame: Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56, and 64 ]Response as defined by a >=30%, >=50%, >=70% and>=90% reduction from Baseline in daily average LBPI score derived from the subject diary at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56, and 64.
- Roland Morris Disability Questionnaire (RMDQ) [ Time Frame: Weeks 16, 24, and 56 ]Cumulative distribution of percent change from Baseline in RMDQ score to Weeks 16, 24, and 56
- Change from Baseline in the Brief Pain Inventory short form (BPI-sf) [ Time Frame: Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, and 64 ]Change from Baseline to Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, and 64 in the Brief Pain Inventory short form (BPI sf) scores for Worst Pain, Average Pain, Pain Interference Index (composite function score), Pain Interference with General Activity, Pain Interference with Walking Ability, Pain Interference with Sleep, and Pain Interference with Normal Work
- Chronic Low Back Pain (CLBP) Responder Index [ Time Frame: Weeks 2, 4, 8 16, 24, 32, 40, 48 and 56 ]Chronic Low Back Pain Responder Index analysis [composite endpoint of average LBPI score, Patient's Global Assessment of Low Back Pain, and RMDQ total score at Weeks 2, 4, 8 16, 24, 32, 40, 48 and 56
- Patients Global Assessment of Low Back Pain Treatment Response [ Time Frame: Weeks 2, 4, 8 16, 24, 32, 40, 48, and 64 ]Treatment Response: Improvement of >=2 points in Patient's Global Assessment of Low Back Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, and 64
- Euro Quality of Life Health State Profile (EQ 5D 5L) [ Time Frame: Weeks 8, 16, 24, 40, 56, and 64 ]Euro Quality of Life Health State Profile (EQ 5D 5L) dimensions and overall health utility score at Baseline, Weeks 8, 16, 24, 40, 56, and 64;
- Work Productivity and Activity Impairment Questionnaire: Low Back Pain [ Time Frame: Weeks 16, 56, or 64 ]Work Productivity and Activity Impairment Questionnaire: Low Back Pain (WPAI:LBP) change from Baseline to Weeks 16, 56, or 64, in the percent work time missed due to chronic low back pain, percent impairment while working due to chronic low back pain, percent overall work impairment due to chronic low back pain, and percent activity impairment due to chronic low back pain
- Discontinuation due to lack of efficacy [ Time Frame: Up to Week 56 ]Incidence of and time to discontinuation due to lack of efficacy
- Usage of rescue medication [ Time Frame: Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and Week 64 ]Usage of rescue medication (incidence, and number of days of usage);
- Usage of rescue medication [ Time Frame: Weeks 2, 4, 8, 12 and 16 ]Usage of rescue medication (amount taken) during Weeks 2, 4, 8, 12 and 16
- Health Care Resource Utilization [ Time Frame: Baseline, Weeks 64 and 80 ]Data will be summarized for each timepoint
- Roland Morris Disability Questionnaire (RMDQ) Response [ Time Frame: Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 ]Response as defined by a >=30%, >=50%, >=70% and>=90% reduction from Baseline Baseline in the RMDQ score at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
- Treatment Satisfaction Questionnaire for Medication [ Time Frame: Week 16 and 56 ]Data will be summarized for each timepoint.
- Patient Reported Treatment Impact Assessment Modified [ Time Frame: Weeks 16 and 56 ]Data will be summarized for each timepoint.
| Estimated Enrollment: | 1800 |
| Actual Study Start Date: | August 18, 2015 |
| Estimated Study Completion Date: | January 16, 2019 |
| Estimated Primary Completion Date: | October 17, 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo to Week 16; tanezumab 5 mg SC |
Biological: Placebo to Week 16; tanezumab 5mg SC
Placebo SC injection every 8 weeks for 2 injections followed by tanezumab 5 mg injection every 8 weeks for 5 injections
|
| Placebo Comparator: Placebo to Week 16, tanezumab 10 mg SC |
Biological: Placebo to Week 16, tanezumab 10 mg SC
Placebo SC injection every 8 weeks for 2 injections, followed by tanezumab 10 mg SC injection for 5 injections
|
| Experimental: Tanezumab 5 mg SC |
Biological: Tanezumab 5 mg SC
Tanezumab 5 mg SC
|
| Experimental: Tanezumab 10 mg SC |
Biological: Tanezumab 10 mg SC
Tanezumab 10 mg SC
|
| Active Comparator: Tramadol PR oral |
Biological: Tramadol PR oral
Tramadol PR oral
|
Detailed Description:
This is a randomized, double blind, placebo and active controlled, multicenter, parallel group Phase 3 study of the efficacy and safety of tanezumab when administered by SC injection for up to 56 weeks in subjects with chronic low back pain. Approximately 1800 subjects will be randomized to 1 of 4 treatment groups in a 2:2:2:3 ratio (ie, 400 subjects per treatment group for the placebo, tanezumab 5 mg and tanezumab 10 mg treatment groups and 600 subjects in the tramadol PR treatment group). Treatment groups will include: 1.) Placebo administered SC at an 8 week interval plus placebo matching tramadol PR up to Week 16. At the Week 16 visit, subjects in this group who meet the efficacy responder criteria will be switched in a blinded fashion in a 1:1 ratio to either tanezumab 5 mg or tanezumab 10 mg administered SC at an 8 week interval plus placebo matching tramadol PR to Week 56; 2.)Tanezumab 5 mg SC administered at an 8 week interval plus placebo matching tramadol PR to Week 56; 3.) Tanezumab 10 mg SC administered at an 8 week interval plus placebo matching tramadol PR to Week 56; 4.) Oral tramadol PR plus placebo administered SC at an 8 week interval to Week 56. The study is designed with a total duration (post randomization) of up to 80 weeks and will consist of three periods: Screening (up to a maximum of 37 days; includes a Washout Period and an Initial Pain Assessment Period), a Double blind Treatment Period (comprised of a 16 week Primary Efficacy Phase and a 40 week Long Term Safety and Efficacy Phase), and a Follow up Period (24 weeks). The Screening Period (beginning up to 37 days prior to Randomization) includes a Washout Period (lasting 2 32 days), if required, and an Initial Pain Assessment Period (the 5 days prior to Randomization/Baseline). Prior to entering the study, subjects must have a documented history of previous inadequate treatment response to medications in 3 different categories of agents commonly used to treat and generally considered effective for the treatment of chronic low back pain.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
-Chronic low back pain ≥3 months in duration, Quebec Task Force in Spinal Disorders class 1 or 2, with documented history of previous inadequate treatment response to at least 3 different categories of agents commonly used and generally considered effective for the treatment of chronic low back pain.
Exclusion Criteria:
--Diagnosis of osteoarthritis of the knee or hip as defined by the American College of Rheumatology (ACR) criteria.
- Subjects who have Kellgren Lawrence Grade > or =2 radiographic evidence of hip or Grade > or=3 radiographic evidence of knee osteoarthritis will be excluded;
- History or radiographic evidence of other diseases that could confound efficacy or safety assessments (e.g., rheumatoid arthritis).
- History or radiographic evidence of orthopedic conditions that may increase the risk of, or confound assessment of joint safety conditions during the study.
- Signs and symptoms of clinically significant cardiac disease within 6 months of the study (e.g., unstable angina, myocardial infarction, resting bradycardia, poorly controlled or untreated hypertension) as defined in the protocol or subjects with any other cardiovascular illness that in the opinion of the Investigator would render a subject unsuitable to participate in the study
- History, diagnosis, or signs and symptoms of clinically significant neurological disease (e.g., transient ischemic attack, stroke, peripheral or autonomic neuropathy) as specified in the protocol
- Subjects with evidence or symptoms consistent with autonomic dysfunction (e.g., orthostatic hypotension and/or autonomic symptoms) as defined in the protocol.
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: NCT02528253
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02528253
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
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Locations
| United States, Alabama | |
| Central Alabama Research | Recruiting |
| Birmingham, Alabama, United States, 35209 | |
| Cahaba Research | Recruiting |
| Birmingham, Alabama, United States, 35242 | |
| Alabama Clinical Research, LLC | Recruiting |
| Mobile, Alabama, United States, 36608 | |
| Horizon Research Partners, LLC | Terminated |
| Mobile, Alabama, United States, 36608 | |
| The Center for Clinical Trials, Inc. | Recruiting |
| Saraland, Alabama, United States, 36571 | |
| United States, Arizona | |
| Ferguson Family Medicine | Recruiting |
| Mesa, Arizona, United States, 85215 | |
| The Pain Center of Arizona | Recruiting |
| Phoenix, Arizona, United States, 85018 | |
| Arizona Research Center | Recruiting |
| Phoenix, Arizona, United States, 85023 | |
| Valley Pain Consultants | Terminated |
| Scottsdale, Arizona, United States, 85254 | |
| United States, Arkansas | |
| KLR Business Group dba Arkansas Clinical Research | Recruiting |
| Little Rock, Arkansas, United States, 72205 | |
| Larry Watkins, MD | Recruiting |
| Little Rock, Arkansas, United States, 72205 | |
| Lynn Institute of the Ozarks | Recruiting |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Anaheim Clinical Trials, LLC | Terminated |
| Anaheim, California, United States, 92801 | |
| Core Healthcare Group | Recruiting |
| Cerritos, California, United States, 90703 | |
| eStudySite | Active, not recruiting |
| Chula Vista, California, United States, 91911 | |
| Triwest Research Associates, LLC | Recruiting |
| El Cajon, California, United States, 92020 | |
| Research Center of Fresno, Inc. | Terminated |
| Fresno, California, United States, 93702 | |
| Neuro-Pain Medical Center | Recruiting |
| Fresno, California, United States, 93710 | |
| Valley Research | Recruiting |
| Fresno, California, United States, 93720 | |
| Collaborative Neuroscience Network, LLC. | Recruiting |
| Garden Grove, California, United States, 92845 | |
| eStudySite (Site & IP Shipment Only) | Recruiting |
| La Mesa, California, United States, 91942 | |
| Collaborative Neuroscience Network, LLC. | Recruiting |
| Long Beach, California, United States, 90806 | |
| University of Southern California | Recruiting |
| Los Angeles, California, United States, 90033 | |
| USC IDS Pharmacy | Recruiting |
| Los Angeles, California, United States, 90033 | |
| Catalina Research Institute, LLC | Recruiting |
| Montclair, California, United States, 91763 | |
| Providence Clinical Research | Recruiting |
| North Hollywood, California, United States, 91606 | |
| Northern California Research | Recruiting |
| Sacramento, California, United States, 95821 | |
| Artemis Institute for Clinical Research | Recruiting |
| San Diego, California, United States, 92103 | |
| Encompass Clinical Research | Recruiting |
| Spring Valley, California, United States, 91978 | |
| Bayview Research Group | Recruiting |
| Valley Village, California, United States, 91607 | |
| Diablo Clinical Research, Inc. | Terminated |
| Walnut Creek, California, United States, 94598 | |
| Elite Clinical Trials, Inc. | Recruiting |
| Wildomar, California, United States, 92595 | |
| United States, Colorado | |
| Alpine Clinical Research Center | Active, not recruiting |
| Boulder, Colorado, United States, 80301 | |
| Mountain View Clinical Research, Inc. | Recruiting |
| Denver, Colorado, United States, 80209 | |
| Mountain View Clinical Research, Inc | Recruiting |
| Denver, Colorado, United States, 80209 | |
| United States, Connecticut | |
| My Health 1st Urgent Care | Terminated |
| Milford, Connecticut, United States, 06460 | |
| Stamford Therapeutics Consortium | Recruiting |
| Stamford, Connecticut, United States, 06905 | |
| New England Research Associates, LLC | Recruiting |
| Trumbull, Connecticut, United States, 06611 | |
| United States, Florida | |
| JEM Research Institute | Recruiting |
| Atlantis, Florida, United States, 33462 | |
| Orthopedic Research Institute | Recruiting |
| Boynton Beach, Florida, United States, 33472 | |
| Clinical Research of South Florida | Terminated |
| Coral Gables, Florida, United States, 33134 | |
| Midland Florida Clinical Research Center, LLC | Recruiting |
| DeLand, Florida, United States, 32720 | |
| S&W Clinical Research | Recruiting |
| Fort Lauderdale, Florida, United States, 33306 | |
| MD Clinical | Recruiting |
| Hallandale Beach, Florida, United States, 33009 | |
| Clinical Neuroscience Solutions, Inc. | Recruiting |
| Jacksonville, Florida, United States, 32256 | |
| Health Awareness, Inc. | Recruiting |
| Jupiter, Florida, United States, 33458 | |
| Crystal Biomedical Research, LLC | Recruiting |
| Miami Lakes, Florida, United States, 33014 | |
| University of Miami Hospital and Clinics/Sylvester Comprehensive Cancer Center Research Pharmacy | Not yet recruiting |
| Miami, Florida, United States, 33136 | |
| University of Miami Hospital and Clinics/Sylvester Comprehensive Treatment Unit | Not yet recruiting |
| Miami, Florida, United States, 33136 | |
| University of Miami Miller School of Medicine | Not yet recruiting |
| Miami, Florida, United States, 33136 | |
| Digital Medical Diagnostic | Recruiting |
| Miami, Florida, United States, 33144 | |
| Columbus Clinical Services LLc | Recruiting |
| Miami, Florida, United States, 33165 | |
| M & M Medical Center, Inc | Recruiting |
| Miami, Florida, United States, 33185 | |
| Quality Research & Medical Center LLC | Recruiting |
| Miami, Florida, United States, 33186 | |
| Sensible Healthcare, LLC. | Recruiting |
| Ocoee, Florida, United States, 34761 | |
| Compass Research, LLC | Recruiting |
| Orlando, Florida, United States, 32806 | |
| National Pain Research Institute | Recruiting |
| Orlando, Florida, United States, 32807 | |
| Pines Clinical Research Inc. | Recruiting |
| Pembroke Pines, Florida, United States, 33028 | |
| Progressive Medical Research | Recruiting |
| Port Orange, Florida, United States, 32127 | |
| Accord Clinical Research, LLC | Recruiting |
| Port Orange, Florida, United States, 32129 | |
| Meridien Research | Recruiting |
| Saint Petersburg, Florida, United States, 33709 | |
| Gulfcoast Research Institute | Active, not recruiting |
| Sarasota, Florida, United States, 34232 | |
| Meridien Research | Terminated |
| Tampa, Florida, United States, 33634 | |
| Palm Beach Research Center | Recruiting |
| West Palm Beach, Florida, United States, 33409 | |
| United States, Georgia | |
| Investigational Drug Services | Not yet recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Emory Orthopaedics & Spine Center | Not yet recruiting |
| Atlanta, Georgia, United States, 30329 | |
| River Birch Research Alliance, LLC | Recruiting |
| Blue Ridge, Georgia, United States, 30513 | |
| Columbus Regional Research Institute | Terminated |
| Columbus, Georgia, United States, 31904 | |
| Center for Advanced Research & Education | Terminated |
| Gainesville, Georgia, United States, 30501 | |
| Drug Studies America | Recruiting |
| Marietta, Georgia, United States, 30060 | |
| Georgia Institute for Clinical Research, LLC | Active, not recruiting |
| Marietta, Georgia, United States, 30060 | |
| Better Health Clinical Research, Inc. | Active, not recruiting |
| Newnan, Georgia, United States, 30265 | |
| Southeast Regional Research Group | Terminated |
| Savannah, Georgia, United States, 31401 | |
| North Georgia Clinical Research | Recruiting |
| Woodstock, Georgia, United States, 30189 | |
| North Georgia Internal Medicine | Recruiting |
| Woodstock, Georgia, United States, 30189 | |
| United States, Hawaii | |
| East-West Medical Research Institute | Recruiting |
| Honolulu, Hawaii, United States, 96814 | |
| United States, Illinois | |
| Medex Healthcare Research Inc | Recruiting |
| Chicago, Illinois, United States, 60602 | |
| Northwestern Memorial Hospital - Arkes Pavilion, Diagnostic Testing Center | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Northwestern University Feinberg School of Medicine | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Northwestern University, McGaw Medical Center | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Northwestern University | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Chicago Clinical Research Institute Inc. | Recruiting |
| Chicago, Illinois, United States, 60616 | |
| Great Lakes Clinical Trials | Recruiting |
| Chicago, Illinois, United States, 60640 | |
| Chicago Anesthesia Pain Specialists | Recruiting |
| Chicago, Illinois, United States, 60657 | |
| Clinical Investigation Specialists, Inc. | Recruiting |
| Skokie, Illinois, United States, 60076 | |
| United States, Indiana | |
| Investigators Research Group, LLC | Recruiting |
| Brownsburg, Indiana, United States, 46112 | |
| MediSphere Medical Research Center, LLC | Recruiting |
| Evansville, Indiana, United States, 47714 | |
| Lafayette Clinical Research Group | Recruiting |
| Lafayette, Indiana, United States, 47905 | |
| Lafayette Regional Vein and Laser Center | Recruiting |
| Lafayette, Indiana, United States, 47905 | |
| Buynak Clinical Research, P.C. | Recruiting |
| Valparaiso, Indiana, United States, 46383 | |
| United States, Iowa | |
| The Iowa Clinic - Internal Medicine | Recruiting |
| Des Moines, Iowa, United States, 50309 | |
| The Iowa Clinic Medical Imaging | Recruiting |
| Des Moines, Iowa, United States, 50309 | |
| The Iowa Clinic | Recruiting |
| Des Moines, Iowa, United States, 50309 | |
| The Iowa Clinic Medical Imaging | Recruiting |
| West Des Moines, Iowa, United States, 50266 | |
| The Iowa Clinic | Recruiting |
| West Des Moines, Iowa, United States, 50266 | |
| United States, Kansas | |
| Mid-America Physiatrists, P.A. | Recruiting |
| Overland Park, Kansas, United States, 66210 | |
| Professional Research Network of Kansas, LLC | Recruiting |
| Wichita, Kansas, United States, 67205 | |
| United States, Kentucky | |
| Otri-Med Corporation | Recruiting |
| Edgewood, Kentucky, United States, 41017 | |
| St Elizabeth Hospital Edgewood | Recruiting |
| Edgewood, Kentucky, United States, 41017 | |
| United States, Louisiana | |
| Willis-Knighton Physician Network/ Spine and Pain Specialist | Recruiting |
| Bossier City, Louisiana, United States, 71111 | |
| Willis-Knighton Physician Network/WKB Family Medicine Associates | Recruiting |
| Bossier City, Louisiana, United States, 71111 | |
| Centex Studies, Inc | Recruiting |
| Lake Charles, Louisiana, United States, 70601 | |
| Best Clinical Trials, LLC | Recruiting |
| New Orleans, Louisiana, United States, 70115 | |
| George Stanley Walker, MD | Recruiting |
| New Orleans, Louisiana, United States, 70115 | |
| United States, Maryland | |
| Klein & Associates, M.D., P.A. | Recruiting |
| Cumberland, Maryland, United States, 21502 | |
| The Center for Rheumatology and Bone Research | Active, not recruiting |
| Wheaton, Maryland, United States, 20902 | |
| United States, Massachusetts | |
| Brigham and Women's Hospital | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Brigham and Women's Hospital | Recruiting |
| Chestnut Hill, Massachusetts, United States, 02467 | |
| Beacon Clinical Research, LLC | Recruiting |
| Quincy, Massachusetts, United States, 02169 | |
| MedVadis Research Corporation | Recruiting |
| Watertown, Massachusetts, United States, 02472 | |
| United States, Michigan | |
| Great Lakes Research Group, Inc. | Recruiting |
| Bay City, Michigan, United States, 48706 | |
| Michigan Orthopaedic Spine Surgeons | Recruiting |
| Rochester Hills, Michigan, United States, 48307 | |
| Oakland Medical Research | Recruiting |
| Troy, Michigan, United States, 48085 | |
| Michigan Pain Consultants | Recruiting |
| Wyoming, Michigan, United States, 49519 | |
| United States, Mississippi | |
| CRC of Jackson, LLC | Recruiting |
| Jackson, Mississippi, United States, 39202 | |
| Physician's Surgery Center | Recruiting |
| Jackson, Mississippi, United States, 39202 | |
| Olive Branch Family Medical Center | Recruiting |
| Olive Branch, Mississippi, United States, 38654 | |
| United States, Missouri | |
| Medex Healthcare Research, Inc. | Recruiting |
| Saint Louis, Missouri, United States, 63117 | |
| United States, Nebraska | |
| Heartland Clinical Research, Inc. | Active, not recruiting |
| Omaha, Nebraska, United States, 68134 | |
| United States, Nevada | |
| Office of Robert Kaplan, DO | Recruiting |
| Las Vegas, Nevada, United States, 89119 | |
| Advanced Biomedical Research of America | Recruiting |
| Las Vegas, Nevada, United States, 89123 | |
| Office of Stephen H. Miller, MD | Recruiting |
| Las Vegas, Nevada, United States, 89144 | |
| United States, New Hampshire | |
| ActivMed Practices & Research, Inc. | Recruiting |
| Portsmouth, New Hampshire, United States, 03801 | |
| United States, New Jersey | |
| Comprehensive Clinical Research | Recruiting |
| Berlin, New Jersey, United States, 08009 | |
| CRI Worldwide, LLC | Recruiting |
| Marlton, New Jersey, United States, 08053 | |
| University Clinical Research Center | Terminated |
| Somerset, New Jersey, United States, 08873 | |
| Premier Research | Recruiting |
| Trenton, New Jersey, United States, 08611 | |
| United States, New Mexico | |
| Albuquerque Clinical Trials, Inc. | Active, not recruiting |
| Albuquerque, New Mexico, United States, 87102 | |
| New Mexico Clinical Research & Osteoporosis Center, Inc. | Recruiting |
| Albuquerque, New Mexico, United States, 87106 | |
| United States, New York | |
| Healthwise Medical Associates | Recruiting |
| Brooklyn, New York, United States, 11206 | |
| Drug Trials America | Recruiting |
| Hartsdale, New York, United States, 10530 | |
| The Medical Research Network, LLC | Recruiting |
| New York, New York, United States, 10128 | |
| AAIR Research Center | Recruiting |
| Rochester, New York, United States, 14618 | |
| University of Rochester | Recruiting |
| Rochester, New York, United States, 14618 | |
| United States, North Carolina | |
| OnSite Clinical Solutions, LLC | Recruiting |
| Huntersville, North Carolina, United States, 28078 | |
| Northstate Clinical Research | Recruiting |
| Lenoir, North Carolina, United States, 28645 | |
| Wake Research Associates, LLC | Recruiting |
| Raleigh, North Carolina, United States, 27612 | |
| Center for Clinical Research, LLC - Winston-Salem | Recruiting |
| Winston-Salem, North Carolina, United States, 27103 | |
| PMG Research of Winston-Salem, LLC | Recruiting |
| Winston-Salem, North Carolina, United States, 27103 | |
| United States, North Dakota | |
| Lillestol Research, LLC | Recruiting |
| Fargo, North Dakota, United States, 58103 | |
| Plains Clinical Research Center, LLC | Recruiting |
| Fargo, North Dakota, United States, 58104 | |
| United States, Ohio | |
| Clinical Inquest Center Ltd | Recruiting |
| Beavercreek, Ohio, United States, 45431 | |
| Valley Medical Research/Valley Medical Primary Care | Terminated |
| Centerville, Ohio, United States, 45459 | |
| Hightop Medical Research Center | Active, not recruiting |
| Cincinnati, Ohio, United States, 45224 | |
| New Horizons Clinical Research | Recruiting |
| Cincinnati, Ohio, United States, 45242 | |
| Optimed Research LTD | Recruiting |
| Columbus, Ohio, United States, 43235 | |
| Prestige Clinical Research | Terminated |
| Franklin, Ohio, United States, 45005 | |
| Great Lakes Medical Research, LLC | Recruiting |
| Mentor, Ohio, United States, 44060 | |
| Oaktree Clinic | Recruiting |
| Mentor, Ohio, United States, 44060 | |
| Bone Joint & Spine Surgeons, Inc. | Recruiting |
| Toledo, Ohio, United States, 43623 | |
| United States, Oklahoma | |
| COR Clinical Research, L.L.C | Active, not recruiting |
| Oklahoma City, Oklahoma, United States, 73103 | |
| Health Research of Oklahoma | Recruiting |
| Oklahoma City, Oklahoma, United States, 73103 | |
| NPC Research | Recruiting |
| Oklahoma City, Oklahoma, United States, 73109 | |
| Lynn Health Science Institute | Recruiting |
| Oklahoma City, Oklahoma, United States, 73112 | |
| United States, Pennsylvania | |
| Brandywine Clinical Research | Recruiting |
| Downingtown, Pennsylvania, United States, 19335 | |
| Altoona Center for Clinical Research | Active, not recruiting |
| Duncansville, Pennsylvania, United States, 16635 | |
| United States, Rhode Island | |
| Omega Medical Research | Recruiting |
| Warwick, Rhode Island, United States, 02886 | |
| United States, South Carolina | |
| TLM Medical Services | Recruiting |
| Columbia, South Carolina, United States, 29204 | |
| DeGarmo Institute of Medical Research | Recruiting |
| Greer, South Carolina, United States, 29651 | |
| Lowcountry Orthopaedics & Sports Medicine | Recruiting |
| North Charleston, South Carolina, United States, 29406 | |
| United States, South Dakota | |
| Health Concepts | Recruiting |
| Rapid City, South Dakota, United States, 57702 | |
| United States, Tennessee | |
| PCET Research Center, LLC | Terminated |
| Knoxville, Tennessee, United States, 37909 | |
| Quality Medical Research | Recruiting |
| Nashville, Tennessee, United States, 37211 | |
| United States, Texas | |
| KRK Medical Research | Terminated |
| Arlington, Texas, United States, 76012 | |
| Advances In Health | Recruiting |
| Houston, Texas, United States, 77030 | |
| Centex Studies, Inc. | Recruiting |
| Houston, Texas, United States, 77058 | |
| Clinical Trial Network | Recruiting |
| Houston, Texas, United States, 77074 | |
| The Pain Relief Center | Active, not recruiting |
| Plano, Texas, United States, 75024 | |
| Quality Research, Inc. | Recruiting |
| San Antonio, Texas, United States, 78209 | |
| Lee Medical Associates, PA | Recruiting |
| San Antonio, Texas, United States, 78213 | |
| Progressive Clinical Research, PA | Recruiting |
| San Antonio, Texas, United States, 78213 | |
| United States, Utah | |
| The Smart Clinic | Recruiting |
| Draper, Utah, United States, 84020 | |
| United States, Virginia | |
| Charlottesville Medical Research Center, LLC | Terminated |
| Charlottesville, Virginia, United States, 22911 | |
| Virginia Research Center | Recruiting |
| Midlothian, Virginia, United States, 23114 | |
| National Clinical Research - Richmond, Inc. | Recruiting |
| Richmond, Virginia, United States, 23294 | |
| United States, Washington | |
| Washington Center for Pain Management | Recruiting |
| Bellevue, Washington, United States, 98004 | |
| Northwest Clinical Research Center | Recruiting |
| Bellevue, Washington, United States, 98007 | |
| Canada, Ontario | |
| SKDS Research Inc. | Recruiting |
| Newmarket, Ontario, Canada, L3Y 5G8 | |
| London Road Diagnostic Clinic & Medical Centre | Recruiting |
| Sarnia, Ontario, Canada, N7T 4X3 | |
| Canada, Quebec | |
| Diex Research Sherbrooke Inc. | Recruiting |
| Sherbrooke, Quebec, Canada, J1H 1Z1 | |
| Canada | |
| G.R.M.O. (Groupe de recherche en maladies osseuses) Inc. | Recruiting |
| Quebec, Canada, G1V 3M7 | |
| Centre de recherche Saint-Louis | Recruiting |
| Quebec, Canada, G1W 4R4 | |
| Denmark | |
| A2 reumatologi og idraesmedicin ApS | Terminated |
| Hillerod, Denmark, 3400 | |
| France | |
| Hopital Cochin | Recruiting |
| Paris Cedex 14, France, 75679 | |
| Hopital Pierre Paul Riquet | Not yet recruiting |
| Toulouse Cedex 9, France, 31059 | |
| Paule de Viguier - Pharmacie Essais cliniques | Not yet recruiting |
| Toulouse Cedex 9, France, 31059 | |
| Hopital PURPAN | Not yet recruiting |
| Toulouse, France, 31059 Cedex9 | |
| Hungary | |
| Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft. | Recruiting |
| Budapest, Hungary, 1033 | |
| Obudai Egeszsegugyi Centrum | Recruiting |
| Budapest, Hungary, 1036 | |
| Dr Réthy Pál Kórház-Rendelőintézet, | Recruiting |
| Békéscsaba, Hungary, 5600 | |
| Jutrix Kft. | Active, not recruiting |
| Kecskemét, Hungary, 6000 | |
| CRU Hungary Kft. | Recruiting |
| Miskolc, Hungary, 3529 | |
| Clinfan Kft. | Active, not recruiting |
| Szekszard, Hungary, 7100 | |
| Tolna Megyei Balassa Janos Korhaz, Ortopediai osztaly | Recruiting |
| Szekszard, Hungary, 7100 | |
| Japan | |
| Aichi Medical University Hospital | Active, not recruiting |
| Nagakute, Aichi, Japan, 480-1195 | |
| Nagoya University Hospital | Active, not recruiting |
| Showa-ku, Nagoya, Aichi, Japan, 466-8560 | |
| Chiba University Hospital | Recruiting |
| Chuo-ku, Chiba, Chiba, Japan, 260-8677 | |
| Funabashi Municipal Medical Center | Active, not recruiting |
| Funabashi, Chiba, Japan, 273-8588 | |
| Chiba Rosai Hospital | Terminated |
| Ichihara, Chiba, Japan, 290-0003 | |
| Chiba Central Medical Center | Recruiting |
| Wakaba-ku, Chiba, Chiba, Japan, 264-0017 | |
| Fukuoka Mirai Hospital | Recruiting |
| Higashi-ku,Fukuoka, Fukuoka, Japan, 813-0017 | |
| Kyushu Rosai Hospital | Recruiting |
| Kokuraminami-ku,Kitakyushu, Fukuoka, Japan, 800-0296 | |
| Takagi Hospital | Recruiting |
| Okawa, Fukuoka, Japan, 831-0016 | |
| Fukushima Medical University Aizu Medical Center | Recruiting |
| Aizuwakamatsu, Fukushima, Japan, 969-3492 | |
| Hakodate Central General Hospital | Recruiting |
| Hakodate, Hokkaido, Japan, 040-8585 | |
| Hakodate Ohmura Orthopedic Hospital | Recruiting |
| Hakodate, Hokkaido, Japan, 041-0802 | |
| Kobe Konan Yamate Clinic | Recruiting |
| Higashinada-ku, Kobe, Hyogo, Japan, 658-0011 | |
| Omuro Orthopedic Clinic | Recruiting |
| Himeji, Hyogo, Japan, 670-0976 | |
| Medical corporate corporation hoshikai Onishi medical clinic | Recruiting |
| Kako-gun, Hyogo, Japan, 675-1115 | |
| Kobe Red Cross Hospital | Recruiting |
| Kobe, Hyogo, Japan, 651-0073 | |
| National Hospital Organization Kanazawa Medical Center | Recruiting |
| Kanazawa, Ishikawa, Japan, 920-8650 | |
| Morita Hospital | Recruiting |
| Komatsu, Ishikawa, Japan, 923-8507 | |
| Misugikai Medical Corporation Otokoyama Hospital | Not yet recruiting |
| Yawata, Kyoto, Japan, 614-8366 | |
| Marunouchi Hospital | Recruiting |
| Matsumoto, Nagano, Japan, 390-8601 | |
| National Hospital Organization Beppu Medical Center | Recruiting |
| Beppu, Oita, Japan, 874-0011 | |
| Sobajima Clinic | Recruiting |
| Higashiosaka, Osaka, Japan, 577-0011 | |
| Rinku General Medical Center | Recruiting |
| Izumisano, Osaka, Japan, 598-8577 | |
| Minamiosaka Hospital | Recruiting |
| Suminoe-ku, Osaka, Osaka, Japan, 559-0012 | |
| Saitama Jikei Hospital | Recruiting |
| Kumagaya, Saitama, Japan, 360-0816 | |
| Hamamatsu University School of Medicine, University Hospital | Recruiting |
| Hamamatsu, Shizuoka, Japan, 431-3192 | |
| Tokyo Medical and Dental University Medical Hospital | Recruiting |
| Bunkyo-ku, Tokyo, Japan, 113-8519 | |
| Fussa Hospital | Active, not recruiting |
| Fussa, Tokyo, Japan, 197-8511 | |
| Tokyo Saiseikai Central Hospital | Recruiting |
| Minato-ku, Tokyo, Japan, 108-0073 | |
| Kohno Clinical Medicine Research Institute Daisan Kitashinagawa Hospital | Recruiting |
| Shinagawa-ku, Tokyo, Japan, 140-0001 | |
| Ohimachi Orthopaedic Clinic | Recruiting |
| Shinagawa-ku, Tokyo, Japan, 140-0014 | |
| Keio University Hospital | Active, not recruiting |
| Shinjuku-ku, Tokyo, Japan, 160-8582 | |
| Yonezawa City Hospital | Active, not recruiting |
| Yonezawa, Yamagata, Japan, 992-8502 | |
| Shimonoseki City Hospital | Recruiting |
| Shimonoseki-shi, Yamaguchi, Japan, 750-8520 | |
| Yamaguchi University Hospital | Recruiting |
| Ube, Yamaguchi, Japan, 755-8505 | |
| Chihaya Hospital | Terminated |
| Fukuoka, Japan, 813-8501 | |
| Kuroda Orthopedic Hospital | Recruiting |
| Fukuoka, Japan, 814-0165 | |
| Fukushima Medical University Hospital | Recruiting |
| Fukushima, Japan, 960-1295 | |
| Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital | Recruiting |
| Hiroshima, Japan, 730-8619 | |
| Saitama Municipal Hospital | Recruiting |
| Saitama, Japan, 336-8522 | |
| Toyama University Hospital | Recruiting |
| Toyama, Japan, 930-0194 | |
| Korea, Republic of | |
| CTC Pharmacy, Seoul National University Hospital | Recruiting |
| Seoul, Korea, Republic of, 03080 | |
| Seoul National University Hospital | Recruiting |
| Seoul, Korea, Republic of, 03080 | |
| Pharmacy Clinical Trial Center, Severance Hospital, Yonsei University Health System (Drug Shipment) | Recruiting |
| Seoul, Korea, Republic of, 03722 | |
| Severance Hospital, Yonsei University Health System | Recruiting |
| Seoul, Korea, Republic of, 03722 | |
| Clinical Trial Pharmacy, Samsung Medical Center (Drug Shipment) | Recruiting |
| Seoul, Korea, Republic of, 06351 | |
| Samsung Medical Center | Recruiting |
| Seoul, Korea, Republic of, 06351 | |
| Spain | |
| Hospital Nuestra Señora de la Esperanza. CICEC | Recruiting |
| Santiago de Compostela, A Coruña, Spain, 15705 | |
| Complejo Hospitalario Universitario A Coruna. Servicio de Farmacia | Recruiting |
| A Coruna, Spain, 15006 | |
| Complejo Hospitalario Universitario A Coruña | Recruiting |
| A Coruna, Spain, 15006 | |
| Instituto de Ciencias Medicas | Recruiting |
| Alicante, Spain, 03004 | |
| Specialist, S.L. | Recruiting |
| Barcelona, Spain, 08006 | |
| Specialist. Farmacia | Recruiting |
| Barcelona, Spain, 08006 | |
| Hospital del M ar Servicio de Farmacia | Recruiting |
| Barcelona, Spain, 08024 | |
| Hospital del Mar | Recruiting |
| Barcelona, Spain, 08024 | |
| Hospital Universitario Quiron-Dexeus | Recruiting |
| Barcelona, Spain, 08025 | |
| Hospital Universitario Quiron-Dexeus. Servicio de Farmacia | Recruiting |
| Barcelona, Spain, 08028 | |
| Hospital Sanitas CIMA. | Recruiting |
| Barcelona, Spain, 08034 | |
| Hospital Universitario La Paz. | Recruiting |
| Madrid, Spain, 28046 | |
| Hospital Universitario La Paz | Recruiting |
| Madrid, Spain, 28046 | |
| Hospital La Moraleja. Pharmacy Service (Drug Shipment Only) | Recruiting |
| Madrid, Spain, 28050 | |
| Hospital La Moraleja | Recruiting |
| Madrid, Spain, 28050 | |
| Hospital Regional Universitario de Malaga | Recruiting |
| Malaga, Spain, 29009 | |
| Hospital Regional Universitario del Malaga | Recruiting |
| Malaga, Spain, 29009 | |
| Sweden | |
| CTC (Clinical Trial Center) Sahlgrenska University Hospital | Recruiting |
| Gothenburg, Sweden, 413 45 | |
| Pharmasite | Recruiting |
| Helsingborg, Sweden, 252 20 | |
| Pharmasite AB | Recruiting |
| Malmo, Sweden, 21152 | |
| ProbarE i Stockholm AB | Recruiting |
| Stockholm, Sweden, 171 45 | |
Sponsors and Collaborators
Pfizer
Eli Lilly and Company
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT02528253 History of Changes |
| Other Study ID Numbers: |
A4091059 2012-005495-34 ( EudraCT Number ) CLBP SC STUDY ( Other Identifier: Alias Study Number ) A4091059 ( Other Identifier: Pfizer ) TANGO ( Other Identifier: Alias Study Number ) |
| Study First Received: | August 11, 2015 |
| Last Updated: | July 7, 2017 |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by Pfizer:
|
Chronic low back pain Chronic pain |
Additional relevant MeSH terms:
|
Back Pain Low Back Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Tramadol |
Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on July 14, 2017