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| ID | Type | Description | Link |
|---|---|---|---|
| CLBP-IV PH2B | Other Identifier | Alias Study Number |
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The purpose of this study is to evaluate the efficacy and safety of multiple doses of tanezumab administered every 8 weeks in treating chronic low back pain. Tanezumab is a monoclonal antibody directed against human nerve growth factor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tanezumab 20 mg IV | Experimental |
| |
| Tanezumab 10 mg IV | Experimental |
| |
| Tanezumab 5 mg IV | Experimental |
| |
| Naproxen | Active Comparator |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tanezumab 20 mg IV | Biological | 2 IV administrations of tanezumab 20 mg at an 8 week interval |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 16: Baseline Observation Carried Forward (BOCF) | Daily average back pain was assessed on an 11-point numeric rating scale (NRS) captured through an interactive voice response system (IVRS). The participant described the chronic low back pain (CLBP) during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain). Baseline value was calculated as mean of the scores over 5 days prior to randomization (initial pain assessment period). Post-baseline value was calculated as mean of the scores over the 7-day period prior to and including the post-baseline visit. Overall possible score range for daily average LBPI at specified visit was 0= no pain to 10= worst possible pain, where higher scores indicated higher pain intensity. | Baseline, Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | RMDQ: back-specific, participant administered questionnaire that assesses how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement if it describes his/her functional ability on the day of assessment. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements marked. Total possible RMDQ score: 0 (best functioning) to 24 (worst functioning), with higher scores indicated greater disability. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pinnacle Research Group, LLC | Anniston | Alabama | 36201 | United States | ||
| Pinnacle Research Group LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26554876 | Derived | 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. | |
| 23628600 | Derived |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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Participants who discontinued due to lack of efficacy or completed the treatment in this study were eligible to enroll in safety extension study A4091039 (NCT00924664).
Participants underwent for a 5-day initial pain assessment period prior to randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16. |
| FG001 | Tanezumab 5 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo for naproxen | Drug | Oral placebo for naproxen twice a day for 16 weeks |
|
| Tanezumab 10 mg IV | Biological | 2 IV administrations of tanezumab 10 mg at an 8 week interval |
|
| Placebo for naproxen | Drug | Oral placebo for naproxen twice a day for 16 weeks |
|
| Tanezumab 5 mg IV | Biological | 2 IV administrations of tanezumab 5 mg at an 8 week interval |
|
| Placebo for naproxen | Drug | Oral placebo for naproxen twice a day for 16 weeks |
|
| Placebo for tanezumab | Biological | 2 IV administrations of placebo for tanezumab at an 8 week interval |
|
| Naproxen | Drug | Oral naproxen 500 mg twice a day for 16 weeks |
|
| Placebo for tanezumab | Biological | 2 IV administrations of placebo for tanezumab at an 8 week interval |
|
| Placebo for naproxen | Drug | Oral placebo for naproxen twice a day for 16 weeks |
|
| Baseline, Week 2, 4, 8, 12, 16 |
| Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Participants answered: "Considering all ways your low back pain affects you, how are you doing today?" Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range:1 to 5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities). | Baseline, Week 2, 4, 8, 12, 16 |
| Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF) | Daily average back pain was assessed on an 11-point numeric rating scale (NRS) captured through an interactive voice response system (IVRS). The participant described the chronic low back pain (CLBP) during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain). Baseline value was calculated as mean of the scores over 5 days prior to randomization (initial pain assessment period). Post-baseline value was calculated as mean of the scores over the 7-day period prior to and including the post-baseline visit. | Baseline, Week 2, 4, 8, 12 |
| Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | Daily average back pain was assessed on an 11-point numeric rating scale (NRS) captured through an interactive voice response system (IVRS). The participant described the chronic low back pain (CLBP) during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain). Baseline value was calculated as mean of the scores over 5 days prior to randomization (initial pain assessment period). Post-baseline value was calculated as mean of the scores over the 7-day period prior to and including the post-baseline visit. Participants with specified reduction (as percent) from baseline at Week 16 are reported. | Baseline, Week 16 |
| Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Daily average back pain was assessed on an 11-point numeric rating scale (NRS) captured through an interactive voice response system (IVRS). The participant described the chronic low back pain (CLBP) during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain). Baseline value was calculated as mean of the scores over 5 days prior to randomization (initial pain assessment period). Post-baseline value was calculated as mean of the scores over the 7-day period prior to and including the post-baseline visit. | Baseline, Week 2, 4, 8, 12, 16 |
| Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | BPI-sf: self-report questionnaire rated on an 11-point scale, consists of 5 questions to assess severity and impact of pain on daily functions. Question 1-4 (Q1-Q4) measure severity of pain (worst, least, average, right now), each question ranging between 0 (no pain) to 10 (pain as bad as you can imagine). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life), each item ranging from 0 (does not interfere) to 10 (completely interferes). Results are reported for worst and average pain, each with a score range: 0 (no pain) and 10 (pain as bad as you can imagine), higher scores indicated worse pain. | Baseline, Week 2, 4, 8, 12, 16 |
| Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | BPI-sf: self-report questionnaire rated on an 11-point scale, consists of 5 questions to assess severity and impact of pain on daily functions. Question 1-4 (Q1-Q4) measure severity of pain (worst, least, average, right now), each question ranging between 0 (no pain) to 10 (pain as bad as you can imagine). Question 5 (Q5) consists of 7 items which measure pain interference (PI) on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life), each item ranging from 0 (does not interfere) to 10 (completely interferes); higher score = greater impairment. The 7 items in Q5 averaged to obtain pain interference index (function composite score), range: 0 (no interference) to 10 (complete interference); higher score = greater impairment. | Baseline, Week 2, 4, 8, 12, 16 |
| Time to Discontinuation Due to Lack of Efficacy | Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method. | Baseline up to Week 16 |
| Number of Participants With Chronic Low Back Pain (CLBP) Responder Index: Baseline Observation Carried Forward (BOCF) | Chronic Low Back Pain (CLBP) Responder Index: A response was defined as reduction of at least 30% in mean daily average LBPI from baseline to a specified week, decrease of at least 30% in PGA of low back pain from baseline to the specified week and no worsening (increase) in RMDQ total score from baseline to the specified week. Participants who were responders were reported. | Week 2, 4, 8, 12, 16 |
| Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | WPAI:SHP is a self-administered questionnaire that measures the effect of general health and symptom severity on work productivity and regular activities. Four scores are derived as percent: activity impairment (AI), impairment while working (IW), overall work impairment (OWI), work time missed (WTM). Each of 4 scores expressed as impairment percentages with a total possible score range of 0 to 100, high percentage= more impairment, less productivity. | Baseline, Week 8, 16 |
| Percentage of Participants Who Used Rescue Medications | In case of inadequate pain relief for CLBP or for non-CLBP related pain, acetaminophen up to 3000 mg per day up to 3 days per week could be taken as rescue medication. | Week 2, 4, 8, 12, 16 |
| Duration of Rescue Medication Use | In case of inadequate pain relief for CLBP or for non-CLBP related pain, acetaminophen up to 3000 mg per day up to 3 days per week could be taken as rescue medication. | Week 2, 4, 8, 12, 16 |
| Amount of Rescue Medication Taken | In case of inadequate pain relief for CLBP or for non-CLBP related pain, acetaminophen up to 3000 mg per day up to 3 days per week could be taken as rescue medication. | Week 2, 4, 8, 12, 16 |
| Change From Baseline Neuropathy Impairment Score (NIS) at Week 8, 16 and 24 | NIS is a standardized instrument used to evaluate signs of peripheral neuropathy in participants. NIS is the sum of scores of 37 items, from both the left and right side of following 4 domains: cranial nerves (5 items), muscle weakness (19 items), reflexes (5 items) and sensation (8 items). Each of 24 items related to cranial nerves and muscle weakness, scored from 0 (normal) to 4 (paralysis); higher scores indicated higher abnormality/impairment. Each of 13 items related to reflexes and sensation, scored as 0 (normal), 1 (decreased) and 2 (absent); higher scores indicated lesser reflexes and sensation. For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits. | Baseline, Week 8, 16, 24 |
| Number of Participants Who Developed Anti-Tanezumab Antibodies | Human serum anti-drug antibody (ADA) samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA). Same participant may have positive ADA result at more than 1 time point. | Baseline (Day 1), Week 8, 16, 24 |
| Plasma Concentration of Tanezumab | Analysis was done by setting concentration values below the lower limit of quantification (LLOQ) to zero. | Baseline (pre-dose and 1 hour [hr] post-dose); Any time point at Week 4 Visit; Week 8 (pre-dose and 1 hr post-dose); Any time point at Week 16 Visit, at Week 24 Visit |
| Total Nerve Growth Factor (NGF) Concentration | Baseline (pre-dose and 1 hour [hr] post-dose); Any time point at Week 4 Visit; Week 8 (pre-dose and 1 hr post-dose); Any time point at Week 16 Visit, at Week 24 Visit |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 24 that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial. | Baseline up to Week 24 |
| Anniston |
| Alabama |
| 36207 |
| United States |
| Pinnacle Research Group, LLC | Anniston | Alabama | 36207 | United States |
| Simon Williamson Clinic, PC | Birmingham | Alabama | 35211 | United States |
| Simon-Williamson Clinic, PC | Hueytown | Alabama | 35023 | United States |
| Saadat Ansari, MD office | Huntsville | Alabama | 35801 | United States |
| Horizon Research Group | Mobile | Alabama | 36608 | United States |
| Radiant Research - Phoenix Southeast | Chandler | Arizona | 85225 | United States |
| Pivotal Research Centers | Peoria | Arizona | 85381 | United States |
| Arizona Research Center | Phoenix | Arizona | 85023 | United States |
| Radiant Research, Inc.: Scottsdale, AZ | Scottsdale | Arizona | 85251 | United States |
| Premiere Phamaceutical Research, LLC | Tempe | Arizona | 85282 | United States |
| Clinical Research Advantage, Inc./Fiel Family and Sports Medicine, PC | Tempe | Arizona | 85283 | United States |
| Alta Clinical Research, LLC | Tucson | Arizona | 85745 | United States |
| Little Rock Family Practice Clinic | Little Rock | Arkansas | 72205 | United States |
| Providence Clinical Research | Burbank | California | 91505 | United States |
| Valley Research | Fresno | California | 93720 | United States |
| Collaborative Neuroscience Network, Inc | Garden Grove | California | 92845 | United States |
| University of California San Diego | La Jolla | California | 92121 | United States |
| Samaritan Center for Medical Research Medical Group | Los Gatos | California | 95032 | United States |
| North County Clinical Research (NCCR) | Oceanside | California | 92056 | United States |
| Advances in Medicine | Rancho Mirage | California | 92270 | United States |
| Quality Control Research, Inc | Roseville | California | 95661 | United States |
| Center for Clinical Trials of Sacramento, Inc. | Sacramento | California | 95823 | United States |
| Wetlin Research Associates, Inc | San Diego | California | 92120 | United States |
| Inland Rheumatology & Osteoporosis Medical Group, Inc. | Upland | California | 91786 | United States |
| Elite Clinical Trials | Wildomar | California | 92595 | United States |
| Alpine Clinical Research Center | Boulder | Colorado | 80304 | United States |
| Clinicos, LLC | Colorado Springs | Colorado | 80904 | United States |
| Stamford Therapeutics Consortium | Stamford | Connecticut | 06905 | United States |
| New England Research Associates, LLC | Trumbull | Connecticut | 06611 | United States |
| Southeast Clinical Research, LLC | Chiefland | Florida | 32626 | United States |
| Southeast Clinical Research | Chiefland | Florida | 32626 | United States |
| Doctors Medical Center of Walton County | DeFuniak Springs | Florida | 32435 | United States |
| Avail Clinical Research, LLC | DeLand | Florida | 32720 | United States |
| SJS Clinical Research, Inc. | Destin | Florida | 32541 | United States |
| CRIA Research | Fort Lauderdale | Florida | 33334 | United States |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | United States |
| Southeast Clinical Research, LLC | Jacksonville | Florida | 32216 | United States |
| Collier Neurologic Specialists | Naples | Florida | 34102 | United States |
| Compass Research, LLC | Orlando | Florida | 32806 | United States |
| University Clinical Research Incorporated | Pembroke Pines | Florida | 33024 | United States |
| Advent Clinical Research Center | Pinellas Park | Florida | 33781 | United States |
| Arthntis & Rheumatic Care Center | South Miami | Florida | 33143 | United States |
| Miami Research Associates | South Miami | Florida | 33143 | United States |
| Meridien Research | St. Petersburg | Florida | 33709 | United States |
| Dale G. Bramlet, MD | St. Petersburg | Florida | 33713 | United States |
| Palm Beach Research Center | West Palm Beach | Florida | 33409 | United States |
| Center for Prospective Outcome Studies | Atlanta | Georgia | 30327 | United States |
| River Birch Research Alliance, LLC | Blue Ridge | Georgia | 30513 | United States |
| Drug Studies America | Marietta | Georgia | 30060 | United States |
| Selah Medical Center, PA | Boise | Idaho | 83704 | United States |
| MediSphere Medical Research Center, LLC | Evansville | Indiana | 47714 | United States |
| Vince and Associates Clinical Research | Overiand Park | Kansas | 66211 | United States |
| Vince and Associates Clinical Research | Overland Park | Kansas | 66212 | United States |
| Clinical Trials Technology, Inc. | Prairie Village | Kansas | 66206 | United States |
| Cotton-O'Neil Clinical Research | Topeka | Kansas | 66606 | United States |
| Central Kentucky Research Association, Inc. | Lexington | Kentucky | 40509 | United States |
| Commonwealth Biomedical Research, LLC | Madisonville | Kentucky | 42431 | United States |
| Arthritis and Diabetes Clinic | Monroe | Louisiana | 71203 | United States |
| Peter A. Holt, MD | Baltimore | Maryland | 21239 | United States |
| Clinical Pharmacology Study Group | Worcester | Massachusetts | 01610 | United States |
| PCM Medical Services | Lansing | Michigan | 48917 | United States |
| The Center for Clinical Trials | Biloxi | Mississippi | 39531 | United States |
| Clinical Research Center of Jackson | Jackson | Mississippi | 39202 | United States |
| Physician's Surgery Center | Jackson | Mississippi | 39202 | United States |
| Clinvest/ A Division of Banyan Group, Inc. | Springfield | Missouri | 65807 | United States |
| Medex Healthcare Research, Inc. | St Louis | Missouri | 63117 | United States |
| Mercy Health Research | St Louis | Missouri | 63141 | United States |
| Quality Clinical Research, Inc. | Omaha | Nebraska | 68114 | United States |
| Meridian Clinical Research, LLC | Omaha | Nebraska | 68134 | United States |
| Clinical Research Consortium | Las Vegas | Nevada | 89119 | United States |
| Mirkil Medical | Las Vegas | Nevada | 89119 | United States |
| Advanced Biomedical Research of America | Las Vegas | Nevada | 89123 | United States |
| Comprehensive Clinical Research | Berlin | New Jersey | 08009 | United States |
| CRI Worldwide | Willingboro | New Jersey | 08046 | United States |
| Albuquerque Clinical Trials | Albuquerque | New Mexico | 87102 | United States |
| Central New York Clinical Research | Manlius | New York | 13104 | United States |
| Medex Healthcare Research, Inc. | New York | New York | 10004 | United States |
| Medex Healthcare Research | New York | New York | 10004 | United States |
| The Medical Research Network, LLC | New York | New York | 10128 | United States |
| Rochester Clinical Research | Rochester | New York | 14609 | United States |
| Finger Lakes Clinical Research | Rochester | New York | 14618 | United States |
| Upstate Clinical Research Associates | Williamsville | New York | 14221 | United States |
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| Wake Internal Medicine Consultants, Inc. | Raleigh | North Carolina | 27612 | United States |
| Wake Research Associates, LLC | Raleigh | North Carolina | 27612 | United States |
| The Center for Clinical Research | Winston-Salem | North Carolina | 27103 | United States |
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| Rapid Medical Research, Inc. | Cleveland | Ohio | 44122 | United States |
| Christine Codding, MD | Oklahoma City | Oklahoma | 73103 | United States |
| Health Research of Oklahoma | Oklahoma City | Oklahoma | 73103 | United States |
| McBride Clinic | Oklahoma City | Oklahoma | 73103 | United States |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | United States |
| Sunstone Medical Research, LLC | Medford | Oregon | 97504 | United States |
| Summit Research Network (Oregon), Inc. | Portland | Oregon | 97210 | United States |
| Allegheny Pain Management | Altoona | Pennsylvania | 16602 | United States |
| East Penn Rheumatology Associates, PC | Bethlehem | Pennsylvania | 18015 | United States |
| Paramount Clinical Research | Bridgeville | Pennsylvania | 15017 | United States |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| CRI Worldwide LLC | Philadelphia | Pennsylvania | 19139 | United States |
| New England Center for Clinical Research | Cranston | Rhode Island | 02920 | United States |
| Omega Medical Research | Warwick | Rhode Island | 02886 | United States |
| Columbia Arthritis Center, P.A. | Columbia | South Carolina | 29204 | United States |
| Southern Orthopaedic Sports Medicine | Columbia | South Carolina | 29204 | United States |
| Radiant Research | Greer | South Carolina | 29651 | United States |
| Health Concepts | Rapid City | South Dakota | 57702 | United States |
| SCRI Research Center | Germantown | Tennessee | 38138 | United States |
| Wolf River Medical Group, LLC | Germantown | Tennessee | 38138 | United States |
| Advanced Therapeutics, Inc. | Johnson City | Tennessee | 37601 | United States |
| Johnson City Internal Medicine | Johnson City | Tennessee | 37601 | United States |
| Capitol Medical Clinic | Austin | Texas | 78705 | United States |
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| DiscoveResearch, Incorporated | Bryan | Texas | 77802 | United States |
| Trinity Hypertension & Metabolic Research Institute Punzi Medical Center | Carrollton | Texas | 75006 | United States |
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| Centex Research, Inc. | Houston | Texas | 77062 | United States |
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| Centex Research | Nassau Bay | Texas | 77058 | United States |
| Office of Theresia Lee, MD | San Antonio | Texas | 78229 | United States |
| Paragon Research Center | San Antonio | Texas | 78229 | United States |
| Progressive Clinical Research, PA | San Antonio | Texas | 78229 | United States |
| Foothill Family Clinic | Salt Lake City | Utah | 84109 | United States |
| Foothill Family Clinic | Salt Lake City | Utah | 84121-6924 | United States |
| Charlottesville Medical Research | Charlottesville | Virginia | 22911 | United States |
| National Clinical Research - Norfolk, Inc. | Norfolk | Virginia | 23502 | United States |
| National Clinical Research, Incorporated | Richmond | Virginia | 23294 | United States |
| Advanced Pain Management | Virginia Beach | Virginia | 23454 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | United States |
| 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. |
Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.
| FG002 | Tanezumab 10 mg | Tanezumab (RN624 or PF-04383119)10 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16. |
| FG003 | Tanezumab 20 mg | Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16. |
| FG004 | Naproxen 500 mg | Naproxen 500 mg tablet orally twice daily up to Week 16 along with placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8. |
| Treated |
|
| Completed Treatment |
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| COMPLETED |
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| NOT COMPLETED |
|
|
Intent-to-treat (ITT) analysis set included all participants who received at least 1 dose of intravenous study medication.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16. |
| BG001 | Tanezumab 5 mg | Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16. |
| BG002 | Tanezumab 10 mg | Tanezumab (RN624 or PF-04383119)10 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16. |
| BG003 | Tanezumab 20 mg | Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16. |
| BG004 | Naproxen 500 mg | Naproxen 500 mg tablet orally twice daily up to Week 16 along with placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 16: Baseline Observation Carried Forward (BOCF) | Daily average back pain was assessed on an 11-point numeric rating scale (NRS) captured through an interactive voice response system (IVRS). The participant described the chronic low back pain (CLBP) during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain). Baseline value was calculated as mean of the scores over 5 days prior to randomization (initial pain assessment period). Post-baseline value was calculated as mean of the scores over the 7-day period prior to and including the post-baseline visit. Overall possible score range for daily average LBPI at specified visit was 0= no pain to 10= worst possible pain, where higher scores indicated higher pain intensity. | ITT analysis set included all participants who received at least 1 dose of intravenous study medication. BOCF method was used to impute missing values. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 16 |
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| Secondary | Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | RMDQ: back-specific, participant administered questionnaire that assesses how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement if it describes his/her functional ability on the day of assessment. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements marked. Total possible RMDQ score: 0 (best functioning) to 24 (worst functioning), with higher scores indicated greater disability. | ITT analysis set included all participants who received at least 1 dose of intravenous study medication. BOCF method was used to impute missing values. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 2, 4, 8, 12, 16 |
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| Secondary | Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Participants answered: "Considering all ways your low back pain affects you, how are you doing today?" Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range:1 to 5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities). | ITT analysis set included all participants who received at least 1 dose of intravenous study medication. BOCF method was used to impute missing values. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 2, 4, 8, 12, 16 |
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| Secondary | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF) | Daily average back pain was assessed on an 11-point numeric rating scale (NRS) captured through an interactive voice response system (IVRS). The participant described the chronic low back pain (CLBP) during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain). Baseline value was calculated as mean of the scores over 5 days prior to randomization (initial pain assessment period). Post-baseline value was calculated as mean of the scores over the 7-day period prior to and including the post-baseline visit. | ITT analysis set included all participants who received at least 1 dose of intravenous study medication. BOCF method was used to impute missing values. | Posted | Mean | Standard Deviation | units on scale | Baseline, Week 2, 4, 8, 12 |
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| Secondary | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | Daily average back pain was assessed on an 11-point numeric rating scale (NRS) captured through an interactive voice response system (IVRS). The participant described the chronic low back pain (CLBP) during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain). Baseline value was calculated as mean of the scores over 5 days prior to randomization (initial pain assessment period). Post-baseline value was calculated as mean of the scores over the 7-day period prior to and including the post-baseline visit. Participants with specified reduction (as percent) from baseline at Week 16 are reported. | ITT analysis set included all participants who received at least 1 dose of intravenous study medication. BOCF method was used to impute missing values. | Posted | Count of Participants | Participants | Baseline, Week 16 |
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| Secondary | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Daily average back pain was assessed on an 11-point numeric rating scale (NRS) captured through an interactive voice response system (IVRS). The participant described the chronic low back pain (CLBP) during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain). Baseline value was calculated as mean of the scores over 5 days prior to randomization (initial pain assessment period). Post-baseline value was calculated as mean of the scores over the 7-day period prior to and including the post-baseline visit. | ITT analysis set included all participants who received at least 1 dose of intravenous study medication. BOCF method was used to impute missing values. | Posted | Number | percentage of participants | Baseline, Week 2, 4, 8, 12, 16 |
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| Secondary | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | BPI-sf: self-report questionnaire rated on an 11-point scale, consists of 5 questions to assess severity and impact of pain on daily functions. Question 1-4 (Q1-Q4) measure severity of pain (worst, least, average, right now), each question ranging between 0 (no pain) to 10 (pain as bad as you can imagine). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life), each item ranging from 0 (does not interfere) to 10 (completely interferes). Results are reported for worst and average pain, each with a score range: 0 (no pain) and 10 (pain as bad as you can imagine), higher scores indicated worse pain. | ITT analysis set included all participants who received at least 1 dose of intravenous study medication. BOCF method was used to impute missing values. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 2, 4, 8, 12, 16 |
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| Secondary | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | BPI-sf: self-report questionnaire rated on an 11-point scale, consists of 5 questions to assess severity and impact of pain on daily functions. Question 1-4 (Q1-Q4) measure severity of pain (worst, least, average, right now), each question ranging between 0 (no pain) to 10 (pain as bad as you can imagine). Question 5 (Q5) consists of 7 items which measure pain interference (PI) on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life), each item ranging from 0 (does not interfere) to 10 (completely interferes); higher score = greater impairment. The 7 items in Q5 averaged to obtain pain interference index (function composite score), range: 0 (no interference) to 10 (complete interference); higher score = greater impairment. | ITT analysis set. BOCF method was used to impute missing values. Here, "Overall number of participants analyzed" = participants who were evaluable for this outcome measure and 'Number Analyzed' = participants who were evaluable for this outcome measure at given time points for each group, respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 2, 4, 8, 12, 16 |
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| Secondary | Time to Discontinuation Due to Lack of Efficacy | Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method. | ITT analysis set included all participants who received at least 1 dose of intravenous study medication. | Posted | Median | Full Range | days | Baseline up to Week 16 |
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| Secondary | Number of Participants With Chronic Low Back Pain (CLBP) Responder Index: Baseline Observation Carried Forward (BOCF) | Chronic Low Back Pain (CLBP) Responder Index: A response was defined as reduction of at least 30% in mean daily average LBPI from baseline to a specified week, decrease of at least 30% in PGA of low back pain from baseline to the specified week and no worsening (increase) in RMDQ total score from baseline to the specified week. Participants who were responders were reported. | ITT analysis set included all participants who received at least 1 dose of intravenous study medication. BOCF method was used to impute missing values. | Posted | Number | participants | Week 2, 4, 8, 12, 16 |
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| Secondary | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | WPAI:SHP is a self-administered questionnaire that measures the effect of general health and symptom severity on work productivity and regular activities. Four scores are derived as percent: activity impairment (AI), impairment while working (IW), overall work impairment (OWI), work time missed (WTM). Each of 4 scores expressed as impairment percentages with a total possible score range of 0 to 100, high percentage= more impairment, less productivity. | ITT analysis set. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure and 'Number Analyzed' signifies those participants who were evaluable for this measure at given time points for each group, respectively. | Posted | Mean | Standard Deviation | percentage of impairment | Baseline, Week 8, 16 |
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| Secondary | Percentage of Participants Who Used Rescue Medications | In case of inadequate pain relief for CLBP or for non-CLBP related pain, acetaminophen up to 3000 mg per day up to 3 days per week could be taken as rescue medication. | ITT analysis set. LOCF method was used to impute missing values. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure and 'Number Analyzed' signifies those participants who were evaluable for this outcome measure at given time points for each group, respectively. | Posted | Number | percentage of participants | Week 2, 4, 8, 12, 16 |
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| Secondary | Duration of Rescue Medication Use | In case of inadequate pain relief for CLBP or for non-CLBP related pain, acetaminophen up to 3000 mg per day up to 3 days per week could be taken as rescue medication. | ITT analysis set. LOCF method was used to impute missing values. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure and 'Number Analyzed' signifies those participants who were evaluable for this outcome measure at given time points for each group, respectively. | Posted | Median | Full Range | days/week | Week 2, 4, 8, 12, 16 |
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| Secondary | Amount of Rescue Medication Taken | In case of inadequate pain relief for CLBP or for non-CLBP related pain, acetaminophen up to 3000 mg per day up to 3 days per week could be taken as rescue medication. | ITT analysis set. LOCF method was used to impute missing values. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure and 'Number Analyzed' signifies those participants who were evaluable for this outcome measure at given time points for each group, respectively. | Posted | Mean | Standard Deviation | mg per week | Week 2, 4, 8, 12, 16 |
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| Secondary | Change From Baseline Neuropathy Impairment Score (NIS) at Week 8, 16 and 24 | NIS is a standardized instrument used to evaluate signs of peripheral neuropathy in participants. NIS is the sum of scores of 37 items, from both the left and right side of following 4 domains: cranial nerves (5 items), muscle weakness (19 items), reflexes (5 items) and sensation (8 items). Each of 24 items related to cranial nerves and muscle weakness, scored from 0 (normal) to 4 (paralysis); higher scores indicated higher abnormality/impairment. Each of 13 items related to reflexes and sensation, scored as 0 (normal), 1 (decreased) and 2 (absent); higher scores indicated lesser reflexes and sensation. For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits. | ITT analysis set included all participants who received at least 1 dose of intravenous study medication. Here 'Number Analyzed' signifies those participants who were evaluable for this measure at given time points for each group, respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 8, 16, 24 |
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| Secondary | Number of Participants Who Developed Anti-Tanezumab Antibodies | Human serum anti-drug antibody (ADA) samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA). Same participant may have positive ADA result at more than 1 time point. | ITT analysis set included all participants who received at least 1 dose of intravenous study medication. Here, "Overall number of participants analyzed" = participants who were evaluable for this outcome measure and 'Number Analyzed' = participants who were evaluable for this outcome measure at given time points for each group, respectively | Posted | Count of Participants | Participants | Baseline (Day 1), Week 8, 16, 24 |
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| Secondary | Plasma Concentration of Tanezumab | Analysis was done by setting concentration values below the lower limit of quantification (LLOQ) to zero. | ITT analysis set included all participants who received at least 1 dose of intravenous study medication. Here, "Overall number of participants analyzed" = participants who were evaluable for this outcome measure and 'Number Analyzed' = participants who were evaluable for this outcome measure at given time points for each group, respectively | Posted | Mean | Standard Deviation | nanogram per milliliter | Baseline (pre-dose and 1 hour [hr] post-dose); Any time point at Week 4 Visit; Week 8 (pre-dose and 1 hr post-dose); Any time point at Week 16 Visit, at Week 24 Visit |
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| Secondary | Total Nerve Growth Factor (NGF) Concentration | ITT analysis set included all participants who received at least 1 dose of intravenous study medication. Here, "Overall number of participants analyzed" = participants who were evaluable for this outcome measure and 'Number Analyzed' = participants who were evaluable for this outcome measure at given time points for each group, respectively | Posted | Mean | Standard Deviation | picogram per mL | Baseline (pre-dose and 1 hour [hr] post-dose); Any time point at Week 4 Visit; Week 8 (pre-dose and 1 hr post-dose); Any time point at Week 16 Visit, at Week 24 Visit |
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| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 24 that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial. | ITT analysis set included all participants who received at least 1 dose of intravenous study medication. | Posted | Count of Participants | Participants | Baseline up to Week 24 |
|
Not provided
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16. | 5 | 230 | 74 | 230 | ||
| EG001 | Tanezumab 5 mg | Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16. | 4 | 232 | 80 | 232 | ||
| EG002 | Tanezumab 10 mg | Tanezumab (RN624 or PF-04383119)10 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16. | 3 | 295 | 114 | 295 | ||
| EG003 | Tanezumab 20 mg | Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16. | 3 | 295 | 134 | 295 | ||
| EG004 | Naproxen 500 mg | Naproxen 500 mg tablet orally twice daily up to Week 16 along with placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8. | 5 | 295 | 76 | 295 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Eye injury | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
| |
| Burning sensation | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dysaesthesia | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hyperaesthesia | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
Results for total duration of response as defined by days with a >=30% and a >=50% reduction from baseline in the daily average LBPI NRS score was not reported due changed in planned analysis.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D009477 | Hereditary Sensory and Autonomic Neuropathies |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |
Not provided
Not provided
| ID | Term |
|---|---|
| C549319 | tanezumab |
| D009288 | Naproxen |
| ID | Term |
|---|---|
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Male |
|
| Change at Week 16 |
|
Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect. |
| ANCOVA |
| <0.001 |
| LS Mean Difference |
| -0.80 |
| Standard Error of the Mean |
| 0.20 |
| 2-Sided |
| 95 |
| -1.19 |
| -0.42 |
| Superiority or Other (legacy) |
| Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect. | ANCOVA | <0.001 | LS Mean Difference | -0.93 | Standard Error of the Mean | 0.20 | 2-Sided | 95 | -1.31 | -0.54 | Superiority or Other (legacy) |
| Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect. | ANCOVA | 0.688 | LS Mean Difference | 0.08 | Standard Error of the Mean | 0.20 | 2-Sided | 95 | -0.31 | 0.47 | Superiority or Other (legacy) |
| Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect. | ANCOVA | 0.035 | LS Mean Difference | -0.39 | Standard Error of the Mean | 0.19 | 2-Sided | 95 | -0.76 | -0.03 | Superiority or Other (legacy) |
| Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect. | ANCOVA | 0.006 | LS Mean Difference | -0.51 | Standard Error of the Mean | 0.19 | 2-Sided | 95 | -0.88 | -0.15 | Superiority or Other (legacy) |
| OG002 | Tanezumab 10 mg | Tanezumab (RN624 or PF-04383119)10 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16. |
| OG003 | Tanezumab 20 mg | Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16. |
| OG004 | Naproxen 500 mg | Naproxen 500 mg tablet orally twice daily up to Week 16 along with placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8. |
|
|
| OG002 | Tanezumab 10 mg | Tanezumab (RN624 or PF-04383119)10 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16. |
| OG003 | Tanezumab 20 mg | Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16. |
| OG004 | Naproxen 500 mg | Naproxen 500 mg tablet orally twice daily up to Week 16 along with placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8. |
|
|
| OG002 |
| Tanezumab 10 mg |
Tanezumab (RN624 or PF-04383119)10 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16. |
| OG003 | Tanezumab 20 mg | Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16. |
| OG004 | Naproxen 500 mg | Naproxen 500 mg tablet orally twice daily up to Week 16 along with placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8. |
|
|
|
| OG002 | Tanezumab 10 mg | Tanezumab (RN624 or PF-04383119)10 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16. |
| OG003 | Tanezumab 20 mg | Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16. |
| OG004 | Naproxen 500 mg | Naproxen 500 mg tablet orally twice daily up to Week 16 along with placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8. |
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| OG002 | Tanezumab 10 mg | Tanezumab (RN624 or PF-04383119)10 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16. |
| OG003 | Tanezumab 20 mg | Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16. |
| OG004 | Naproxen 500 mg | Naproxen 500 mg tablet orally twice daily up to Week 16 along with placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8. |
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|
Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16. |
| OG002 | Tanezumab 10 mg | Tanezumab (RN624 or PF-04383119)10 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16. |
| OG003 | Tanezumab 20 mg | Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16. |
| OG004 | Naproxen 500 mg | Naproxen 500 mg tablet orally twice daily up to Week 16 along with placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8. |
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| OG001 |
| Tanezumab 5 mg |
Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16. |
| OG002 | Tanezumab 10 mg | Tanezumab (RN624 or PF-04383119)10 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16. |
| OG003 | Tanezumab 20 mg | Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16. |
| OG004 | Naproxen 500 mg | Naproxen 500 mg tablet orally twice daily up to Week 16 along with placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8. |
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|
Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.
| OG004 | Naproxen 500 mg | Naproxen 500 mg tablet orally twice daily up to Week 16 along with placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8. |
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|
| OG003 | Tanezumab 20 mg | Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16. |
| OG004 | Naproxen 500 mg | Naproxen 500 mg tablet orally twice daily up to Week 16 along with placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8. |
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|
| OG002 |
| Tanezumab 10 mg |
Tanezumab (RN624 or PF-04383119)10 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16. |
| OG003 | Tanezumab 20 mg | Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16. |
| OG004 | Naproxen 500 mg | Naproxen 500 mg tablet orally twice daily up to Week 16 along with placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8. |
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|
| OG003 | Tanezumab 20 mg | Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16. |
| OG004 | Naproxen 500 mg | Naproxen 500 mg tablet orally twice daily up to Week 16 along with placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8. |
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|
| OG003 | Tanezumab 20 mg | Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16. |
| OG004 | Naproxen 500 mg | Naproxen 500 mg tablet orally twice daily up to Week 16 along with placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8. |
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|
| OG003 | Tanezumab 20 mg | Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16. |
| OG004 | Naproxen 500 mg | Naproxen 500 mg tablet orally twice daily up to Week 16 along with placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8. |
|
|
Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.
| OG002 | Tanezumab 10 mg | Tanezumab (RN624 or PF-04383119)10 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16. |
| OG003 | Tanezumab 20 mg | Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16. |
| OG004 | Naproxen 500 mg | Naproxen 500 mg tablet orally twice daily up to Week 16 along with placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8. |
|
|
Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.
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|
|
|
| OG003 | Tanezumab 20 mg | Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16. |
| OG004 | Naproxen 500 mg | Naproxen 500 mg tablet orally twice daily up to Week 16 along with placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8. |
|
|
| OG002 |
| Tanezumab 10 mg |
Tanezumab (RN624 or PF-04383119)10 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16. |
| OG003 | Tanezumab 20 mg | Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16. |
| OG004 | Naproxen 500 mg | Naproxen 500 mg tablet orally twice daily up to Week 16 along with placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8. |
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