A Study of Tanezumab in Adults With Chronic Low Back Pain

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00876187

Collaborator

(none)

1,359

Enrollment

135

Locations

Arms

19.6

Actual Duration (Months)

10.1

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain	Biological: Tanezumab 20 mg IV Drug: Placebo for naproxen Biological: Tanezumab 10 mg IV Drug: Placebo for naproxen Biological: Tanezumab 5 mg IV Drug: Placebo for naproxen Biological: Placebo for tanezumab Drug: Naproxen Biological: Placebo for tanezumab Drug: Placebo for naproxen	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

1359 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A RANDOMIZED, DOUBLE-BLIND, MULTI-DOSE, ACTIVE- AND PLACEBO-CONTROLLED, MULTI-CENTER, PARALLEL GROUP STUDY OF THE ANALGESIC EFFECTS OF TANEZUMAB IN ADULT PATIENTS WITH CHRONIC LOW BACK PAIN

Actual Study Start Date :

Jun 15, 2009

Actual Primary Completion Date :

Jun 16, 2010

Actual Study Completion Date :

Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tanezumab 20 mg IV	Biological: Tanezumab 20 mg IV 2 IV administrations of tanezumab 20 mg at an 8 week interval Drug: Placebo for naproxen Oral placebo for naproxen twice a day for 16 weeks
Experimental: Tanezumab 10 mg IV	Biological: Tanezumab 10 mg IV 2 IV administrations of tanezumab 10 mg at an 8 week interval Drug: Placebo for naproxen Oral placebo for naproxen twice a day for 16 weeks
Experimental: Tanezumab 5 mg IV	Biological: Tanezumab 5 mg IV 2 IV administrations of tanezumab 5 mg at an 8 week interval Drug: Placebo for naproxen Oral placebo for naproxen twice a day for 16 weeks
Active Comparator: Naproxen	Biological: Placebo for tanezumab 2 IV administrations of placebo for tanezumab at an 8 week interval Drug: Naproxen Oral naproxen 500 mg twice a day for 16 weeks
Placebo Comparator: Placebo	Biological: Placebo for tanezumab 2 IV administrations of placebo for tanezumab at an 8 week interval Drug: Placebo for naproxen Oral placebo for naproxen twice a day for 16 weeks

Outcome Measures

Primary Outcome Measures

Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 16: Baseline Observation Carried Forward (BOCF) [Baseline, Week 16]
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.

Secondary Outcome Measures

Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) [Baseline, Week 2, 4, 8, 12, 16]
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.
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) [Baseline, Week 2, 4, 8, 12, 16]
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).
Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF) [Baseline, Week 2, 4, 8, 12]
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.
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) [Baseline, Week 16]
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.
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) [Baseline, Week 2, 4, 8, 12, 16]
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.
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) [Baseline, Week 2, 4, 8, 12, 16]
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.
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 [Baseline, Week 2, 4, 8, 12, 16]
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.
Time to Discontinuation Due to Lack of Efficacy [Baseline up to Week 16]
Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method.
Number of Participants With Chronic Low Back Pain (CLBP) Responder Index: Baseline Observation Carried Forward (BOCF) [Week 2, 4, 8, 12, 16]
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.
Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 [Baseline, Week 8, 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.
Percentage of Participants Who Used Rescue Medications [Week 2, 4, 8, 12, 16]
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.
Duration of Rescue Medication Use [Week 2, 4, 8, 12, 16]
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.
Amount of Rescue Medication Taken [Week 2, 4, 8, 12, 16]
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.
Change From Baseline Neuropathy Impairment Score (NIS) at Week 8, 16 and 24 [Baseline, Week 8, 16, 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.
Number of Participants Who Developed Anti-Tanezumab Antibodies [Baseline (Day 1), Week 8, 16, 24]
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.
Plasma Concentration of Tanezumab [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]
Analysis was done by setting concentration values below the lower limit of quantification (LLOQ) to zero.
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) [Baseline up to Week 24]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Present with duration of low back pain of ≥3 months requiring regular use of analgesic medication (>4 days per week for the past month). Analgesic medication may consist of NSAIDs, selective COX-2 inhibitors, immediate release opioids, or combinations, with certain protocol-defined limitations.
Primary location of low back pain must be between the 12th thoracic vertebra and the lower gluteal folds, with or without radiation into the posterior thigh
Must meet criteria for pain severity and global assessment of low back pain at Screening and Baseline visits
Female patients of child-bearing potential (and male patients with female partners who are of child-bearing potential) must use 2 methods of contraception throughout the study
Patients must be willing to discontinue all pain medications for chronic low back pain except rescue medication and not use prohibited pain medications throughout the duration of the study

Exclusion Criteria:

History of lumbosacral radiculopathy within the past 2 years.
Back pain due to visceral disorder (eg, endometriosis).
Back pain due to major trauma or osteoporotic compression fracture in the past 6 months.
History of rheumatoid arthritis, seronegative spondyloarthropathy, Paget's disease of spine, pelvis or femur; fibromyalgia; tumors or infections of the spinal cord.
Surgical intervention during the past 6 months for the treatment of low back pain or plans for surgical intervention during the course of the study.
Current or pending worker's compensation, litigation, disability, or any other monetary settlement regarding his/her CLBP or any other pain condition, or any closed claim within the past 5 years.
Use of any analgesic or muscle relaxant within 48 hours prior to the five days before Baseline
Patients receiving only acetaminophen, gabapentin or pregabalin to manage their chronic low back pain.
Patients taking >325 mg/day of aspirin.
Use of any antidepressants with the exception of stable treatment with selective serotonin reuptake inhibitors (SSRIs).
Use of any sedatives/hypnotics, anxiolytics, tranquilizers, or benzodiazepines unless daily dose has been stable and will remain unchanged throughout the study period.
Systemic corticosteroid therapy within 30 days (inhaled and topical corticosteroids are permitted).
Local or epidural injection of corticosteroids, as well as injections of corticosteroids in the back within 3 months.
Botulinum toxin (Botox®) injection for chronic low back pain within 4 months.
Requirement for new, concomitant physiotherapy including, but not limited to, transdermal electroneural stimulation (TENS), massage or spinal manipulation for the duration of the study period.
Active or suspected esophageal, gastric, pyloric channel, or duodenal ulceration within 3 months, or any history of gastrointestinal bleeding.
Current use of lithium or anticoagulant agents.
Known hypersensitivity or intolerance to NSAIDs; history of asthma, urticaria, or allergic type reactions after taking aspirin or NSAIDs.
Inflammatory bowel disease, a chronic or acute renal or hepatic disorder, a significant coagulation defect, or other condition that might preclude the use of an NSAID.
History of intolerance to acetaminophen or paracetamol or any of its excipients.
History of known alcohol, analgesic or narcotic abuse within 2 years.
Presence of drugs of abuse (including prescription medications without a valid prescription), other illegal drugs or marijuana in the urine toxicology screen obtained at Screening.
History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG fusion protein.
Use of biologics other than study medication, including any live vaccines, within 3 months, or use during the study (intranasal Flumist® vaccine is an exception).
Signs and symptoms of clinically significant cardiac disease.
Diagnosis of a transient ischemic attack within the 6 months, or residual deficits from stroke that would preclude completion of required study activities.
History of cancer within 5 years.
Use of any investigational medication within 30 days (3 months for investigational biologics).
Expected to undergo a therapeutic procedure or to use any analgesic other than those specified in the protocol throughout the study period.
Previous exposure to exogenous NGF or to an anti NGF antibody.
Screening laboratory results and blood pressure within specified limits.
Positive Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV) tests at screening.
History, diagnosis, or signs and symptoms of clinically significant neurological disease.
History, diagnosis, signs or symptoms of any clinically significant psychiatric disorder.
Hospital admission for depression or suicide attempt within 5 years or active, severe major depression at Screening.
Likelihood of being non compliant with study procedures.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pinnacle Research Group, LLC	Anniston	Alabama	United States	36201
2	Pinnacle Research Group LLC	Anniston	Alabama	United States	36207
3	Pinnacle Research Group, LLC	Anniston	Alabama	United States	36207
4	Simon Williamson Clinic, PC	Birmingham	Alabama	United States	35211
5	Simon-Williamson Clinic, PC	Hueytown	Alabama	United States	35023
6	Saadat Ansari, MD office	Huntsville	Alabama	United States	35801
7	Horizon Research Group	Mobile	Alabama	United States	36608
8	Radiant Research - Phoenix Southeast	Chandler	Arizona	United States	85225
9	Pivotal Research Centers	Peoria	Arizona	United States	85381
10	Arizona Research Center	Phoenix	Arizona	United States	85023
11	Radiant Research, Inc.: Scottsdale, AZ	Scottsdale	Arizona	United States	85251
12	Premiere Phamaceutical Research, LLC	Tempe	Arizona	United States	85282
13	Clinical Research Advantage, Inc./Fiel Family and Sports Medicine, PC	Tempe	Arizona	United States	85283
14	Alta Clinical Research, LLC	Tucson	Arizona	United States	85745
15	Little Rock Family Practice Clinic	Little Rock	Arkansas	United States	72205
16	Providence Clinical Research	Burbank	California	United States	91505
17	Valley Research	Fresno	California	United States	93720
18	Collaborative Neuroscience Network, Inc	Garden Grove	California	United States	92845
19	University of California San Diego	La Jolla	California	United States	92121
20	Samaritan Center for Medical Research Medical Group	Los Gatos	California	United States	95032
21	North County Clinical Research (NCCR)	Oceanside	California	United States	92056
22	Advances in Medicine	Rancho Mirage	California	United States	92270
23	Quality Control Research, Inc	Roseville	California	United States	95661
24	Center for Clinical Trials of Sacramento, Inc.	Sacramento	California	United States	95823
25	Wetlin Research Associates, Inc	San Diego	California	United States	92120
26	Inland Rheumatology & Osteoporosis Medical Group, Inc.	Upland	California	United States	91786
27	Elite Clinical Trials	Wildomar	California	United States	92595
28	Alpine Clinical Research Center	Boulder	Colorado	United States	80304
29	Clinicos, LLC	Colorado Springs	Colorado	United States	80904
30	Stamford Therapeutics Consortium	Stamford	Connecticut	United States	06905
31	New England Research Associates, LLC	Trumbull	Connecticut	United States	06611
32	Southeast Clinical Research, LLC	Chiefland	Florida	United States	32626
33	Southeast Clinical Research	Chiefland	Florida	United States	32626
34	Doctors Medical Center of Walton County	DeFuniak Springs	Florida	United States	32435
35	Avail Clinical Research, LLC	DeLand	Florida	United States	32720
36	SJS Clinical Research, Inc.	Destin	Florida	United States	32541
37	CRIA Research	Fort Lauderdale	Florida	United States	33334
38	Jacksonville Center for Clinical Research	Jacksonville	Florida	United States	32216
39	Southeast Clinical Research, LLC	Jacksonville	Florida	United States	32216
40	Collier Neurologic Specialists	Naples	Florida	United States	34102
41	Compass Research, LLC	Orlando	Florida	United States	32806
42	University Clinical Research Incorporated	Pembroke Pines	Florida	United States	33024
43	Advent Clinical Research Center	Pinellas Park	Florida	United States	33781
44	Meridien Research	Saint Petersburg	Florida	United States	33709
45	Dale G. Bramlet, MD	Saint Petersburg	Florida	United States	33713
46	Arthntis & Rheumatic Care Center	South Miami	Florida	United States	33143
47	Miami Research Associates	South Miami	Florida	United States	33143
48	Palm Beach Research Center	West Palm Beach	Florida	United States	33409
49	Center for Prospective Outcome Studies	Atlanta	Georgia	United States	30327
50	River Birch Research Alliance, LLC	Blue Ridge	Georgia	United States	30513
51	Drug Studies America	Marietta	Georgia	United States	30060
52	Selah Medical Center, PA	Boise	Idaho	United States	83704
53	MediSphere Medical Research Center, LLC	Evansville	Indiana	United States	47714
54	Vince and Associates Clinical Research	Overiand Park	Kansas	United States	66211
55	Vince and Associates Clinical Research	Overland Park	Kansas	United States	66212
56	Clinical Trials Technology, Inc.	Prairie Village	Kansas	United States	66206
57	Cotton-O'Neil Clinical Research	Topeka	Kansas	United States	66606
58	Central Kentucky Research Association, Inc.	Lexington	Kentucky	United States	40509
59	Commonwealth Biomedical Research, LLC	Madisonville	Kentucky	United States	42431
60	Arthritis and Diabetes Clinic	Monroe	Louisiana	United States	71203
61	Peter A. Holt, MD	Baltimore	Maryland	United States	21239
62	Clinical Pharmacology Study Group	Worcester	Massachusetts	United States	01610
63	PCM Medical Services	Lansing	Michigan	United States	48917
64	The Center for Clinical Trials	Biloxi	Mississippi	United States	39531
65	Clinical Research Center of Jackson	Jackson	Mississippi	United States	39202
66	Physician's Surgery Center	Jackson	Mississippi	United States	39202
67	Medex Healthcare Research, Inc.	Saint Louis	Missouri	United States	63117
68	Mercy Health Research	Saint Louis	Missouri	United States	63141
69	Clinvest/ A Division of Banyan Group, Inc.	Springfield	Missouri	United States	65807
70	Quality Clinical Research, Inc.	Omaha	Nebraska	United States	68114
71	Meridian Clinical Research, LLC	Omaha	Nebraska	United States	68134
72	Clinical Research Consortium	Las Vegas	Nevada	United States	89119
73	Mirkil Medical	Las Vegas	Nevada	United States	89119
74	Advanced Biomedical Research of America	Las Vegas	Nevada	United States	89123
75	Comprehensive Clinical Research	Berlin	New Jersey	United States	08009
76	CRI Worldwide	Willingboro	New Jersey	United States	08046
77	Albuquerque Clinical Trials	Albuquerque	New Mexico	United States	87102
78	Central New York Clinical Research	Manlius	New York	United States	13104
79	Medex Healthcare Research, Inc.	New York	New York	United States	10004
80	Medex Healthcare Research	New York	New York	United States	10004
81	The Medical Research Network, LLC	New York	New York	United States	10128
82	Rochester Clinical Research	Rochester	New York	United States	14609
83	Finger Lakes Clinical Research	Rochester	New York	United States	14618
84	Upstate Clinical Research Associates	Williamsville	New York	United States	14221
85	Pharmquest	Greensboro	North Carolina	United States	27408
86	Northstate Clinical Research, PLLC	Lenoir	North Carolina	United States	28645
87	Wake Internal Medicine Consultants, Inc.	Raleigh	North Carolina	United States	27612
88	Wake Research Associates, LLC	Raleigh	North Carolina	United States	27612
89	The Center for Clinical Research	Winston-Salem	North Carolina	United States	27103
90	Community Research	Cincinnati	Ohio	United States	45227
91	Sterling Research	Cincinnati	Ohio	United States	45246
92	Rapid Medical Research, Inc.	Cleveland	Ohio	United States	44122
93	Christine Codding, MD	Oklahoma City	Oklahoma	United States	73103
94	Health Research of Oklahoma	Oklahoma City	Oklahoma	United States	73103
95	McBride Clinic	Oklahoma City	Oklahoma	United States	73103
96	Lynn Health Science Institute	Oklahoma City	Oklahoma	United States	73112
97	Sunstone Medical Research, LLC	Medford	Oregon	United States	97504
98	Summit Research Network (Oregon), Inc.	Portland	Oregon	United States	97210
99	Allegheny Pain Management	Altoona	Pennsylvania	United States	16602
100	East Penn Rheumatology Associates, PC	Bethlehem	Pennsylvania	United States	18015
101	Paramount Clinical Research	Bridgeville	Pennsylvania	United States	15017
102	Altoona Center for Clinical Research	Duncansville	Pennsylvania	United States	16635
103	CRI Worldwide LLC	Philadelphia	Pennsylvania	United States	19139
104	New England Center for Clinical Research	Cranston	Rhode Island	United States	02920
105	Omega Medical Research	Warwick	Rhode Island	United States	02886
106	Columbia Arthritis Center, P.A.	Columbia	South Carolina	United States	29204
107	Southern Orthopaedic Sports Medicine	Columbia	South Carolina	United States	29204
108	Radiant Research	Greer	South Carolina	United States	29651
109	Health Concepts	Rapid City	South Dakota	United States	57702
110	SCRI Research Center	Germantown	Tennessee	United States	38138
111	Wolf River Medical Group, LLC	Germantown	Tennessee	United States	38138
112	Advanced Therapeutics, Inc.	Johnson City	Tennessee	United States	37601
113	Johnson City Internal Medicine	Johnson City	Tennessee	United States	37601
114	Capitol Medical Clinic	Austin	Texas	United States	78705
115	Walter F. Chase, MD, PA	Austin	Texas	United States	78705
116	FutureSearch Trials of Neurology	Austin	Texas	United States	78756
117	FutureSearch Trials	Austin	Texas	United States	78756
118	DiscoveResearch, Inc.	Beaumont	Texas	United States	77701
119	DiscoveResearch, Incorporated	Bryan	Texas	United States	77802
120	Trinity Hypertension & Metabolic Research Institute Punzi Medical Center	Carrollton	Texas	United States	75006
121	KRK Medical Research	Dallas	Texas	United States	75230
122	Advances In Health, Inc.	Houston	Texas	United States	77030
123	Centex Research, Inc.	Houston	Texas	United States	77062
124	Centex Research	Houston	Texas	United States	77065
125	Centex Research	Nassau Bay	Texas	United States	77058
126	Office of Theresia Lee, MD	San Antonio	Texas	United States	78229
127	Paragon Research Center	San Antonio	Texas	United States	78229
128	Progressive Clinical Research, PA	San Antonio	Texas	United States	78229
129	Foothill Family Clinic	Salt Lake City	Utah	United States	84109
130	Foothill Family Clinic	Salt Lake City	Utah	United States	84121-6924
131	Charlottesville Medical Research	Charlottesville	Virginia	United States	22911
132	National Clinical Research - Norfolk, Inc.	Norfolk	Virginia	United States	23502
133	National Clinical Research, Incorporated	Richmond	Virginia	United States	23294
134	Advanced Pain Management	Virginia Beach	Virginia	United States	23454
135	Northwest Clinical Research Center	Bellevue	Washington	United States	98007

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

To obtain contact information for a study center near you, click here.

Publications

None provided.

Responsible Party:

Pfizer

ClinicalTrials.gov Identifier:

NCT00876187

Other Study ID Numbers:

A4091012
CLBP-IV PH2B

First Posted:

Apr 6, 2009

Last Update Posted:

Jul 7, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Keywords provided by Pfizer

randomized controlled trial

monoclonal antibody

nerve growth factor

naproxen

Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details	Participants underwent for a 5-day initial pain assessment period prior to randomization.
Pre-assignment Detail	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).

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Tanezumab 20 mg	Naproxen 500 mg
Arm/Group Description	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.	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.	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.	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.	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.
Period Title: Overall Study
STARTED	233	233	298	297	298
Treated	230	232	295	295	295
Completed Treatment	128	146	193	188	185
COMPLETED	23	18	19	22	27
NOT COMPLETED	210	215	279	275	271

Baseline Characteristics

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Tanezumab 20 mg	Naproxen 500 mg	Total
Arm/Group Description	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.	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.	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.	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.	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.	Total of all reporting groups
Overall Participants	230	232	295	295	295	1347
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51.2 (13.2)	51.5 (14.2)	52.0 (13.9)	51.2 (12.9)	52.6 (13.2)	51.8 (13.5)
Sex: Female, Male (Count of Participants)
Female	125 54.3%	115 49.6%	157 53.2%	165 55.9%	152 51.5%	714 53%
Male	105 45.7%	117 50.4%	138 46.8%	130 44.1%	143 48.5%	633 47%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 16: Baseline Observation Carried Forward (BOCF)
Description	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.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description
ITT analysis set included all participants who received at least 1 dose of intravenous study medication. BOCF method was used to impute missing values.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Tanezumab 20 mg	Naproxen 500 mg
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	230	232	295	295	295
Baseline	6.71 (1.37)	6.62 (1.36)	6.57 (1.39)	6.74 (1.48)	6.77 (1.38)
Change at Week 16	-1.25 (2.01)	-1.55 (2.07)	-2.02 (2.40)	-2.19 (2.52)	-1.70 (2.28)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg
	Comments	Treatment difference and 95 percent (%) confidence interval (CI) was based on least squares (LS) mean. Analysis of Covariance (ANCOVA) was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.113
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least Squares (LS) Mean Difference
	Estimated Value	-0.33
	Confidence Interval	(2-Sided) 95% -0.74 to 0.08
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.21
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.80
	Confidence Interval	(2-Sided) 95% -1.19 to -0.42
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.20
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 20 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.93
	Confidence Interval	(2-Sided) 95% -1.31 to -0.54
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.20
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg, Naproxen 500 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.688
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.08
	Confidence Interval	(2-Sided) 95% -0.31 to 0.47
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.20
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg, Naproxen 500 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.035
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.39
	Confidence Interval	(2-Sided) 95% -0.76 to -0.03
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.19
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 20 mg, Naproxen 500 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.006
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.51
	Confidence Interval	(2-Sided) 95% -0.88 to -0.15
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.19
	Estimation Comments

2. Secondary Outcome

Title	Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
Description	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.
Time Frame	Baseline, Week 2, 4, 8, 12, 16

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Tanezumab 20 mg	Naproxen 500 mg
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	228	232	295	295	295
Baseline	12.79 (4.74)	12.24 (4.92)	12.98 (5.11)	13.00 (4.97)	12.86 (4.93)
Change at Week 2	-1.68 (3.74)	-2.47 (4.61)	-2.59 (4.41)	-2.39 (4.61)	-2.28 (4.19)
Change at Week 4	-1.85 (4.04)	-2.81 (4.52)	-3.45 (4.90)	-3.35 (4.87)	-2.39 (4.24)
Change at Week 8	-1.86 (4.13)	-2.62 (4.43)	-2.93 (4.75)	-3.47 (5.17)	-2.27 (4.12)
Change at Week 12	-1.91 (4.13)	-2.23 (3.82)	-3.16 (4.97)	-3.26 (4.81)	-2.44 (4.12)
Change at Week 16	-1.76 (4.15)	-2.27 (4.07)	-3.20 (5.07)	-2.82 (4.65)	-2.08 (3.85)

3. Secondary Outcome

Title	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)
Description	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).
Time Frame	Baseline, Week 2, 4, 8, 12, 16

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Tanezumab 20 mg	Naproxen 500 mg
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	229	232	295	294	295
Baseline	3.41 (0.58)	3.41 (0.60)	3.33 (0.56)	3.36 (0.56)	3.35 (0.56)
Change at Week 2	-0.55 (0.80)	-0.62 (0.91)	-0.66 (0.89)	-0.62 (1.00)	-0.59 (0.84)
Change at Week 4	-0.53 (0.88)	-0.78 (0.89)	-0.77 (0.90)	-0.84 (0.95)	-0.67 (0.90)
Change at Week 8	-0.52 (0.84)	-0.66 (0.93)	-0.71 (0.92)	-0.78 (0.93)	-0.54 (0.87)
Change at Week 12	-0.48 (0.82)	-0.69 (0.91)	-0.73 (0.90)	-0.74 (0.98)	-0.59 (0.86)
Change at Week 16	-0.42 (0.78)	-0.59 (0.96)	-0.63 (0.91)	-0.67 (0.93)	-0.49 (0.86)

4. Secondary Outcome

Title	Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)
Description	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.
Time Frame	Baseline, Week 2, 4, 8, 12

Outcome Measure Data

Analysis Population Description
ITT analysis set included all participants who received at least 1 dose of intravenous study medication. BOCF method was used to impute missing values.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Tanezumab 20 mg	Naproxen 500 mg
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	230	232	295	295	295
Change at Week 2	-1.29 (1.84)	-1.48 (1.79)	-1.83 (1.89)	-1.68 (2.19)	-1.85 (1.98)
Change at Week 4	-1.50 (1.95)	-1.94 (2.00)	-2.47 (2.22)	-2.44 (2.33)	-2.05 (2.05)
Change at Week 8	-1.40 (2.05)	-1.82 (1.99)	-2.23 (2.25)	-2.32 (2.40)	-1.82 (2.05)
Change at Week 12	-1.49 (2.14)	-1.92 (2.17)	-2.27 (2.47)	-2.37 (2.56)	-1.93 (2.29)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg
	Comments	Change at Week 2: 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.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.221
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.22
	Confidence Interval	(2-Sided) 95% -0.57 to 0.13
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.18
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg
	Comments	Change at Week 2: 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.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.57
	Confidence Interval	(2-Sided) 95% -0.90 to -0.24
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.17
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 20 mg
	Comments	Change at Week 2: 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.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.027
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.37
	Confidence Interval	(2-Sided) 95% -0.70 to -0.04
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.17
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg, Naproxen 500 mg
	Comments	Change at Week 2: 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.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.082
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.29
	Confidence Interval	(2-Sided) 95% -0.04 to 0.62
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.17
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg, Naproxen 500 mg
	Comments	Change at Week 2: 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.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.703
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.06
	Confidence Interval	(2-Sided) 95% -0.37 to 0.25
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.16
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 20 mg, Naproxen 500 mg
	Comments	Change at Week 2: 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.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.379
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.14
	Confidence Interval	(2-Sided) 95% -0.17 to 0.45
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.16
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg
	Comments	Change at Week 4: 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.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.012
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.49
	Confidence Interval	(2-Sided) 95% -0.87 to -0.11
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.19
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg
	Comments	Change at Week 4: 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.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.03
	Confidence Interval	(2-Sided) 95% -1.39 to -0.67
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.18
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 20 mg
	Comments	Change at Week 4: 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.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.94
	Confidence Interval	(2-Sided) 95% -1.31 to -0.58
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.18
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg, Naproxen 500 mg
	Comments	Change at Week 4: 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.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.862
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.03
	Confidence Interval	(2-Sided) 95% -0.33 to 0.39
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.18
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg, Naproxen 500 mg
	Comments	Change at Week 4: 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.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.51
	Confidence Interval	(2-Sided) 95% -0.85 to -0.17
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.17
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 20 mg, Naproxen 500 mg
	Comments	Change at Week 4: 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.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.014
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.43
	Confidence Interval	(2-Sided) 95% -0.76 to -0.09
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.17
	Estimation Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg
	Comments	Change at Week 8: 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.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.019
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.47
	Confidence Interval	(2-Sided) 95% -0.86 to -0.08
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.20
	Estimation Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg
	Comments	Change at Week 8: 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.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.88
	Confidence Interval	(2-Sided) 95% -1.25 to -0.51
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.19
	Estimation Comments

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 20 mg
	Comments	Change at Week 8: 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.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.93
	Confidence Interval	(2-Sided) 95% -1.29 to -0.56
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.19
	Estimation Comments

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg, Naproxen 500 mg
	Comments	Change at Week 8: 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.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.668
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.08
	Confidence Interval	(2-Sided) 95% -0.45 to 0.29
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.19
	Estimation Comments

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg, Naproxen 500 mg
	Comments	Change at Week 8: 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.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.005
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.49
	Confidence Interval	(2-Sided) 95% -0.84 to -0.15
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.18
	Estimation Comments

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 20 mg, Naproxen 500 mg
	Comments	Change at Week 8: 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.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.54
	Confidence Interval	(2-Sided) 95% -0.88 to -0.19
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.18
	Estimation Comments

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg
	Comments	Change at Week 12: 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.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.032
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.46
	Confidence Interval	(2-Sided) 95% -0.89 to -0.04
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.22
	Estimation Comments

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg
	Comments	Change at Week 12: 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.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.81
	Confidence Interval	(2-Sided) 95% -1.21 to -0.41
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.20
	Estimation Comments

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 20 mg
	Comments	Change at Week 12: 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.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.88
	Confidence Interval	(2-Sided) 95% -1.28 to -0.48
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.20
	Estimation Comments

Statistical Analysis 22

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg, Naproxen 500 mg
	Comments	Change at Week 12: 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.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.773
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.06
	Confidence Interval	(2-Sided) 95% -0.46 to 0.34
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.20
	Estimation Comments

Statistical Analysis 23

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg, Naproxen 500 mg
	Comments	Change at Week 12: 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.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.035
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.40
	Confidence Interval	(2-Sided) 95% -0.78 to -0.03
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.19
	Estimation Comments

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 20 mg, Naproxen 500 mg
	Comments	Change at Week 12: 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.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.014
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.47
	Confidence Interval	(2-Sided) 95% -0.85 to -0.10
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.19
	Estimation Comments

5. Secondary Outcome

Title	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)
Description	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.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description
ITT analysis set included all participants who received at least 1 dose of intravenous study medication. BOCF method was used to impute missing values.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Tanezumab 20 mg	Naproxen 500 mg
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	230	232	295	295	295
Greater than (>) 0%	103 44.8%	121 52.2%	171 58%	174 59%	160 54.2%
Greater than or equal to (>=)10%	90 39.1%	111 47.8%	159 53.9%	162 54.9%	146 49.5%
>= 20%	78 33.9%	99 42.7%	136 46.1%	145 49.2%	128 43.4%
>= 30%	62 27%	83 35.8%	123 41.7%	137 46.4%	111 37.6%
>= 40%	53 23%	64 27.6%	112 38%	120 40.7%	92 31.2%
>= 50%	39 17%	59 25.4%	94 31.9%	104 35.3%	78 26.4%
>= 60%	31 13.5%	42 18.1%	78 26.4%	80 27.1%	60 20.3%
>= 70%	22 9.6%	29 12.5%	62 21%	54 18.3%	37 12.5%
>= 80%	12 5.2%	24 10.3%	45 15.3%	40 13.6%	26 8.8%
>= 90%	8 3.5%	12 5.2%	30 10.2%	26 8.8%	16 5.4%
= 100%	5 2.2%	9 3.9%	20 6.8%	16 5.4%	9 3.1%

6. Secondary Outcome

Title	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)
Description	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.
Time Frame	Baseline, Week 2, 4, 8, 12, 16

Outcome Measure Data

Analysis Population Description
ITT analysis set included all participants who received at least 1 dose of intravenous study medication. BOCF method was used to impute missing values.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Tanezumab 20 mg	Naproxen 500 mg
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	230	232	295	295	295
Week 2: >=30% reduction	27.4 11.9%	32.8 14.1%	42.4 14.4%	41.0 13.9%	39.0 13.2%
Week 2: >=50% reduction	11.3 4.9%	20.7 8.9%	19.3 6.5%	22.0 7.5%	24.4 8.3%
Week 4: >=30% reduction	33.9 14.7%	43.5 18.8%	54.2 18.4%	52.5 17.8%	42.0 14.2%
Week 4: >=50% reduction	16.5 7.2%	28.9 12.5%	35.6 12.1%	35.9 12.2%	25.8 8.7%
Week 8: >=30% reduction	32.2 14%	43.1 18.6%	48.1 16.3%	50.8 17.2%	39.7 13.5%
Week 8: >=50% reduction	18.7 8.1%	25.4 10.9%	32.5 11%	35.3 12%	22.7 7.7%
Week 12: >=30% reduction	31.3 13.6%	42.7 18.4%	48.1 16.3%	50.5 17.1%	42.7 14.5%
Week 12: >=50% reduction	22.2 9.7%	31.0 13.4%	36.3 12.3%	40.0 13.6%	30.8 10.4%
Week 16: >=30% reduction	27.0 11.7%	35.8 15.4%	41.7 14.1%	46.4 15.7%	37.6 12.7%
Week 16: >=50% reduction	17.0 7.4%	25.4 10.9%	31.9 10.8%	35.3 12%	26.4 8.9%

7. Secondary Outcome

Title	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)
Description	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.
Time Frame	Baseline, Week 2, 4, 8, 12, 16

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Tanezumab 20 mg	Naproxen 500 mg
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	228	232	295	295	294
Baseline: Worst Pain	7.27 (1.51)	7.10 (1.53)	7.04 (1.49)	7.36 (1.59)	7.28 (1.51)
Baseline: Average Pain	6.22 (1.44)	6.25 (1.51)	6.08 (1.52)	6.35 (1.45)	6.27 (1.41)
Change at Week 2: Worst Pain	-1.63 (2.33)	-1.76 (2.14)	-2.19 (2.41)	-2.08 (2.60)	-1.97 (2.38)
Change at Week 2: Average Pain	-1.16 (1.93)	-1.43 (1.91)	-1.69 (2.11)	-1.65 (2.34)	-1.57 (2.07)
Change at Week 4: Worst Pain	-1.63 (2.38)	-2.21 (2.28)	-2.57 (2.50)	-2.88 (2.64)	-2.16 (2.50)
Change at Week 4: Average Pain	-1.19 (1.95)	-1.88 (1.91)	-2.09 (2.18)	-2.32 (2.34)	-1.77 (2.10)
Change at Week 8: Worst Pain	-1.54 (2.33)	-1.94 (2.30)	-2.35 (2.45)	-2.55 (2.70)	-1.98 (2.31)
Change at Week 8: Average Pain	-1.19 (1.93)	-1.78 (1.99)	-1.98 (2.18)	-2.18 (2.42)	-1.61 (1.97)
Change at Week 12: Worst Pain	-1.63 (2.43)	-1.99 (2.41)	-2.53 (2.73)	-2.70 (2.84)	-2.13 (2.55)
Change at Week 12: Average Pain	-1.32 (2.12)	-1.75 (2.11)	-2.13 (2.35)	-2.26 (2.54)	-1.73 (2.13)
Change at Week 16: Worst Pain	-1.55 (2.35)	-1.75 (2.34)	-2.20 (2.66)	-2.36 (2.78)	-1.94 (2.49)
Change at Week 16: Average Pain	-1.20 (1.95)	-1.58 (2.14)	-1.89 (2.37)	-2.03 (2.47)	-1.66 (2.19)

8. Secondary Outcome

Title	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
Description	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.
Time Frame	Baseline, Week 2, 4, 8, 12, 16

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Tanezumab 20 mg	Naproxen 500 mg
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	228	231	295	295	295
Change at Week 2: Pain Interference Index	-1.33 (2.20)	-1.59 (2.14)	-1.97 (2.33)	-1.81 (2.63)	-1.75 (2.46)
Change at Week 4: Pain Interference Index	-1.48 (2.19)	-1.99 (2.12)	-2.40 (2.31)	-2.63 (2.44)	-2.01 (2.34)
Change at Week 12: Pain Interference Index	-1.38 (2.19)	-1.62 (2.21)	-2.21 (2.47)	-2.38 (2.60)	-1.81 (2.39)
Change at Week 16: Pain Interference Index	-1.32 (2.01)	-1.52 (2.19)	-2.02 (2.48)	-2.17 (2.44)	-1.59 (2.28)
Change at Week 8: Pain Interference Index	-1.33 (2.20)	-1.65 (2.16)	-2.15 (2.34)	-2.37 (2.45)	-1.71 (2.22)
Change at Week 2: General Activity	-1.30 (2.58)	-1.72 (2.51)	-2.20 (2.75)	-2.06 (3.00)	-1.92 (2.72)
Change at Week 4: General Activity	-1.33 (2.55)	-2.17 (2.42)	-2.64 (2.59)	-2.90 (2.84)	-2.08 (2.72)
Change at Week 8: General Activity	-1.36 (2.57)	-1.70 (2.52)	-2.27 (2.63)	-2.53 (2.76)	-1.77 (2.64)
Change at Week 12: General Activity	-1.43 (2.54)	-1.76 (2.54)	-2.39 (2.73)	-2.62 (2.87)	-1.90 (2.68)
Change at Week 16: General Activity	-1.34 (2.21)	-1.68 (2.55)	-2.20 (2.76)	-2.26 (2.71)	-1.65 (2.56)
Change at Week 2: Walking Ability	-1.29 (2.71)	-1.59 (2.52)	-1.83 (2.69)	-1.81 (2.94)	-1.73 (2.71)
Change at Week 4: Walking Ability	-1.48 (2.71)	-1.91 (2.59)	-2.32 (2.59)	-2.58 (2.88)	-2.00 (2.63)
Change at Week 8: Walking Ability	-1.24 (2.56)	-1.62 (2.47)	-2.01 (2.66)	-2.36 (2.88)	-1.72 (2.52)
Change at Week 12: Walking Ability	-1.28 (2.41)	-1.63 (2.50)	-2.13 (2.68)	-2.34 (2.82)	-1.80 (2.55)
Change at Week 16: Walking Ability	-1.17 (2.16)	-1.49 (2.29)	-1.91 (2.71)	-2.14 (2.72)	-1.53 (2.52)
Change at Week 2: Normal Work	-1.33 (2.37)	-1.75 (2.57)	-2.01 (2.61)	-2.01 (2.90)	-1.67 (2.67)
Change at Week 4: Normal Work	-1.59 (2.36)	-2.03 (2.49)	-2.49 (2.57)	-2.79 (2.75)	-2.03 (2.55)
Change at Week 8: Normal Work	-1.31 (2.35)	-1.72 (2.46)	-2.25 (2.64)	-2.58 (2.75)	-1.76 (2.49)
Change at Week 12: Normal Work	-1.43 (2.25)	-1.76 (2.43)	-2.35 (2.75)	-2.57 (2.85)	-1.85 (2.65)
Change at Week 16: Normal Work	-1.27 (2.15)	-1.55 (2.45)	-2.09 (2.74)	-2.40 (2.76)	-1.65 (2.47)
Change at Week 2: Pain Interference with Sleep	-1.4 (2.72)	-1.7 (2.58)	-2.0 (2.89)	-1.7 (3.09)	-2.2 (2.90)
Change at Week 4: Pain Interference with Sleep	-1.6 (2.52)	-2.3 (2.62)	-2.6 (2.87)	-2.7 (2.89)	-2.2 (2.72)
Change at Week 8: Pain Interference with Sleep	-1.4 (2.54)	-1.9 (2.62)	-2.4 (2.86)	-2.4 (2.83)	-1.9 (2.54)
Change at Week 12: Pain Interference with Sleep	-1.5 (2.49)	-1.8 (2.69)	-2.4 (3.04)	-2.5 (3.00)	-2.0 (2.66)
Change at Week 16: Pain Interference with Sleep	-1.4 (2.29)	-1.7 (2.66)	-2.3 (3.04)	-2.3 (2.82)	-1.8 (2.60)

9. Secondary Outcome

Title	Time to Discontinuation Due to Lack of Efficacy
Description	Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method.
Time Frame	Baseline up to Week 16

Outcome Measure Data

Analysis Population Description
ITT analysis set included all participants who received at least 1 dose of intravenous study medication.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Tanezumab 20 mg	Naproxen 500 mg
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	230	232	295	295	295
Median (Full Range) [days]	NA	NA	NA	NA	NA

10. Secondary Outcome

Title	Number of Participants With Chronic Low Back Pain (CLBP) Responder Index: Baseline Observation Carried Forward (BOCF)
Description	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.
Time Frame	Week 2, 4, 8, 12, 16

Outcome Measure Data

Analysis Population Description
ITT analysis set included all participants who received at least 1 dose of intravenous study medication. BOCF method was used to impute missing values.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Tanezumab 20 mg	Naproxen 500 mg
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	230	232	295	295	295
Week 2	38 16.5%	48 20.7%	77 26.1%	80 27.1%	69 23.4%
Week 4	52 22.6%	70 30.2%	114 38.6%	113 38.3%	79 26.8%
Week 8	40 17.4%	62 26.7%	96 32.5%	103 34.9%	64 21.7%
Week 12	45 19.6%	60 25.9%	104 35.3%	105 35.6%	83 28.1%
Week 16	44 19.1%	52 22.4%	90 30.5%	89 30.2%	63 21.4%

11. Secondary Outcome

Title	Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16
Description	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.
Time Frame	Baseline, Week 8, 16

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Tanezumab 20 mg	Naproxen 500 mg
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	229	232	295	295	295
Baseline: Activity Impairment	58.77 (22.88)	55.15 (22.63)	59.32 (21.48)	60.81 (20.74)	59.97 (21.27)
Baseline: Impairment While Working	49.19 (24.85)	45.17 (23.51)	49.15 (22.11)	49.62 (26.01)	48.90 (24.16)
Baseline: Overall Work Impairment	6.29 (21.06)	6.68 (21.61)	7.51 (21.18)	10.71 (26.29)	8.30 (23.43)
Baseline: Work Time Missed	1.97 (8.69)	3.17 (12.03)	2.02 (7.22)	3.82 (11.50)	3.26 (11.79)
Change at Week 8: Activity Impairment	-14.58 (24.31)	-15.80 (25.16)	-24.96 (26.32)	-27.08 (28.65)	-18.53 (24.08)
Change at Week 8: Impairment While Working	-14.79 (24.79)	-10.75 (25.42)	-21.98 (25.54)	-19.21 (45.39)	-16.70 (23.23)
Change at Week 8: Overall Work Impairment	0.43 (21.56)	0.08 (19.74)	-3.83 (22.24)	-6.64 (24.52)	-4.58 (20.24)
Change at Week 8: Work Time Missed	0.58 (8.78)	0.16 (9.53)	-0.38 (9.12)	-2.15 (12.35)	-1.74 (9.25)
Change at Week 16: Activity Impairment	-22.50 (24.11)	-19.45 (25.51)	-29.95 (27.08)	-31.79 (25.78)	-24.28 (24.62)
Change at Week 16: Impairment While Working	-20.60 (22.56)	-15.22 (24.05)	-27.65 (26.17)	-24.57 (26.34)	-21.05 (24.54)
Change at Week 16:Overall Work Impairment	-2.52 (14.15)	-1.72 (15.37)	-3.92 (24.38)	-7.71 (24.10)	-6.68 (22.62)
Change at Week 16:Work Time Missed	-0.79 (6.67)	-0.09 (7.49)	-0.24 (11.20)	-2.98 (10.69)	-2.30 (11.60)

12. Secondary Outcome

Title	Percentage of Participants Who Used Rescue Medications
Description	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.
Time Frame	Week 2, 4, 8, 12, 16

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Tanezumab 20 mg	Naproxen 500 mg
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	230	232	293	292	294
Week 2	70.3 30.6%	69.7 30%	74.1 25.1%	73.4 24.9%	60.8 20.6%
Week 4	63.9 27.8%	53.9 23.2%	54.3 18.4%	53.4 18.1%	53.2 18%
Week 8	54.8 23.8%	49.6 21.4%	50.9 17.3%	47.6 16.1%	48.3 16.4%
Week 12	40.4 17.6%	40.5 17.5%	45.1 15.3%	38.7 13.1%	44.6 15.1%
Week 16	42.6 18.5%	41.4 17.8%	43.0 14.6%	38.0 12.9%	41.2 14%

13. Secondary Outcome

Title	Duration of Rescue Medication Use
Description	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.
Time Frame	Week 2, 4, 8, 12, 16

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Tanezumab 20 mg	Naproxen 500 mg
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	230	232	293	292	294
Week 2	2.0	2.0	2.0	2.0	1.0
Week 4	2.0	1.0	1.0	1.0	1.0
Week 8	1.0	0.0	1.0	0.0	0.0
Week 12	0.0	0.0	0.0	0.0	0.0
Week 16	0.0	0.0	0.0	0.0	0.0

14. Secondary Outcome

Title	Amount of Rescue Medication Taken
Description	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.
Time Frame	Week 2, 4, 8, 12, 16

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Tanezumab 20 mg	Naproxen 500 mg
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	230	232	293	292	294
Week 2	4168.12 (4708.74)	4305.19 (5102.74)	3952.22 (4527.82)	4306.90 (4880.47)	3350.52 (4564.20)
Week 4	3547.83 (4860.04)	3252.16 (5189.48)	2583.62 (3966.56)	2688.36 (4314.58)	2680.89 (4120.78)
Week 8	2910.87 (4483.80)	2633.62 (4309.14)	2829.35 (4458.51)	2558.22 (4232.71)	2477.89 (4270.55)
Week 12	2619.57 (5350.37)	2256.47 (4350.69)	2511.95 (4164.31)	2351.03 (4297.87)	2455.78 (4580.69)
Week 16	2523.91 (4493.14)	2140.09 (4167.33)	2250.85 (3979.75)	2369.86 (4417.07)	2448.98 (4677.93)

15. Secondary Outcome

Title	Change From Baseline Neuropathy Impairment Score (NIS) at Week 8, 16 and 24
Description	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.
Time Frame	Baseline, Week 8, 16, 24

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Tanezumab 20 mg	Naproxen 500 mg
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	230	232	295	295	295
Baseline	0.97 (2.68)	1.16 (3.04)	1.03 (2.79)	1.31 (4.75)	1.02 (2.82)
Change at Week 8	-0.15 (1.43)	-0.41 (2.79)	-0.09 (1.49)	-0.38 (3.61)	-0.06 (1.14)
Change at Week 16	-0.30 (1.67)	-0.27 (1.96)	0.05 (1.36)	0.02 (1.63)	-0.18 (1.43)
Change at Week 24	-0.74 (3.47)	-0.15 (1.09)	0.10 (1.04)	-0.46 (1.22)	-0.48 (1.48)

16. Secondary Outcome

Title	Number of Participants Who Developed Anti-Tanezumab Antibodies
Description	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.
Time Frame	Baseline (Day 1), Week 8, 16, 24

Outcome Measure Data

Analysis Population Description
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

Arm/Group Title	Tanezumab 5 mg	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.	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.
Measure Participants	226	288	289
Baseline	0 0%	1 0.4%	0 0%
Week 8	0 0%	0 0%	0 0%
Week 16	0 0%	1 0.4%	1 0.3%
Week 24	0 0%	1 0.4%	1 0.3%

17. Secondary Outcome

Title	Plasma Concentration of Tanezumab
Description	Analysis was done by setting concentration values below the lower limit of quantification (LLOQ) to zero.
Time Frame	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

Outcome Measure Data

Analysis Population Description
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

Arm/Group Title	Tanezumab 5 mg	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.	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.
Measure Participants	225	288	288
Baseline: pre-dose	70.7627 (315.3581)	60.2354 (383.8924)	40.9396 (317.3858)
Baseline: 1 hr post-dose	1944.46 (572.9289)	4105.46 (1495.906)	8460.14 (2983.547)
Week 4	472.248 (238.5394)	983.377 (346.1361)	1983.72 (598.7860)
Week 8: pre-dose	240.405 (333.2990)	442.843 (208.6190)	1081.69 (997.0692)
Week 8: 1 hr post-dose	2026.01 (693.5790)	4637.82 (2630.921)	9161.84 (4274.392)
Week 16	239.804 (245.3006)	531.014 (256.1994)	1393.40 (1219.270)
Week 24	276.991 (402.0603)	636.217 (567.9855)	1222.17 (1105.125)

18. Secondary Outcome

Title	Total Nerve Growth Factor (NGF) Concentration
Description
Time Frame	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

Outcome Measure Data

Analysis Population Description
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

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Tanezumab 20 mg	Naproxen 500 mg
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	209	216	277	268	266
Baseline: pre-dose	34.65 (11.68)	44.38 (49.12)	55.66 (202.0)	61.79 (220.7)	35.50 (12.38)
Baseline: 1 hr post-dose	37.90 (11.99)	96.76 (35.08)	113.33 (251.5)	126.50 (192.8)	40.30 (13.10)
Week 4	92.33 (655.1)	3217.6 (1134)	3981.7 (1362)	4456.7 (1325)	38.17 (16.11)
Week 8: pre-dose	126.66 (707.6)	2671.7 (1249)	3624.7 (1398)	4238.6 (1604)	41.47 (80.11)
Week 8: 1 hr post-dose	124.71 (750.3)	2943.5 (1334)	3950.9 (1479)	4929.1 (1775)	69.74 (241.8)
Week 16	41.96 (23.56)	3263.0 (1539)	4490.5 (1953)	5842.2 (2377)	135.17 (810.2)
Week 24	226.61 (916.4)	2602.0 (1486)	3549.5 (1747)	4420.3 (1776)	38.77 (15.66)

19. Secondary Outcome

Title	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description	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.
Time Frame	Baseline up to Week 24

Outcome Measure Data

Analysis Population Description
ITT analysis set included all participants who received at least 1 dose of intravenous study medication.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Tanezumab 20 mg	Naproxen 500 mg
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	230	232	295	295	295
AEs	120 52.2%	141 60.8%	171 58%	190 64.4%	142 48.1%
SAEs	5 2.2%	4 1.7%	3 1%	3 1%	5 1.7%

Adverse Events

	Placebo		Tanezumab 5 mg		Tanezumab 10 mg		Tanezumab 20 mg		Naproxen 500 mg
Time Frame
Adverse Event Reporting Description	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.

Arm/Group Title	Placebo		Tanezumab 5 mg		Tanezumab 10 mg		Tanezumab 20 mg		Naproxen 500 mg
Arm/Group Description	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.		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.		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.		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.		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.
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Tanezumab 5 mg		Tanezumab 10 mg		Tanezumab 20 mg		Naproxen 500 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/230 (2.2%)		4/232 (1.7%)		3/295 (1%)		3/295 (1%)		5/295 (1.7%)
Cardiac disorders
Cardiac failure congestive	0/230 (0%)		0/232 (0%)		0/295 (0%)		0/295 (0%)		1/295 (0.3%)
General disorders
Chest pain	1/230 (0.4%)		0/232 (0%)		0/295 (0%)		0/295 (0%)		0/295 (0%)
Non-cardiac chest pain	2/230 (0.9%)		0/232 (0%)		0/295 (0%)		0/295 (0%)		0/295 (0%)
Pyrexia	1/230 (0.4%)		0/232 (0%)		0/295 (0%)		0/295 (0%)		0/295 (0%)
Infections and infestations
Pneumonia	0/230 (0%)		1/232 (0.4%)		0/295 (0%)		0/295 (0%)		0/295 (0%)
Urinary tract infection	0/230 (0%)		0/232 (0%)		0/295 (0%)		0/295 (0%)		1/295 (0.3%)
Injury, poisoning and procedural complications
Ankle fracture	0/230 (0%)		0/232 (0%)		0/295 (0%)		1/295 (0.3%)		0/295 (0%)
Eye injury	1/230 (0.4%)		0/232 (0%)		0/295 (0%)		0/295 (0%)		0/295 (0%)
Femur fracture	0/230 (0%)		1/232 (0.4%)		0/295 (0%)		0/295 (0%)		0/295 (0%)
Fibula fracture	0/230 (0%)		0/232 (0%)		0/295 (0%)		1/295 (0.3%)		0/295 (0%)
Metabolism and nutrition disorders
Dehydration	0/230 (0%)		0/232 (0%)		1/295 (0.3%)		0/295 (0%)		0/295 (0%)
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion	0/230 (0%)		0/232 (0%)		1/295 (0.3%)		0/295 (0%)		0/295 (0%)
Muscular weakness	0/230 (0%)		0/232 (0%)		0/295 (0%)		1/295 (0.3%)		0/295 (0%)
Pain in extremity	1/230 (0.4%)		0/232 (0%)		0/295 (0%)		0/295 (0%)		0/295 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma	0/230 (0%)		0/232 (0%)		0/295 (0%)		0/295 (0%)		1/295 (0.3%)
Nervous system disorders
Burning sensation	0/230 (0%)		0/232 (0%)		0/295 (0%)		1/295 (0.3%)		0/295 (0%)
Convulsion	1/230 (0.4%)		0/232 (0%)		0/295 (0%)		0/295 (0%)		1/295 (0.3%)
Headache	0/230 (0%)		1/232 (0.4%)		0/295 (0%)		0/295 (0%)		0/295 (0%)
Psychiatric disorders
Depression	0/230 (0%)		0/232 (0%)		0/295 (0%)		0/295 (0%)		1/295 (0.3%)
Suicide attempt	0/230 (0%)		0/232 (0%)		1/295 (0.3%)		0/295 (0%)		0/295 (0%)
Renal and urinary disorders
Calculus ureteric	0/230 (0%)		0/232 (0%)		0/295 (0%)		1/295 (0.3%)		0/295 (0%)
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism	0/230 (0%)		1/232 (0.4%)		0/295 (0%)		0/295 (0%)		0/295 (0%)
Vascular disorders
Deep vein thrombosis	0/230 (0%)		1/232 (0.4%)		0/295 (0%)		0/295 (0%)		0/295 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Tanezumab 5 mg		Tanezumab 10 mg		Tanezumab 20 mg		Naproxen 500 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	74/230 (32.2%)		80/232 (34.5%)		114/295 (38.6%)		134/295 (45.4%)		76/295 (25.8%)
Gastrointestinal disorders
Diarrhoea	6/230 (2.6%)		5/232 (2.2%)		8/295 (2.7%)		8/295 (2.7%)		4/295 (1.4%)
Nausea	2/230 (0.9%)		6/232 (2.6%)		6/295 (2%)		12/295 (4.1%)		9/295 (3.1%)
Constipation	1/230 (0.4%)		1/232 (0.4%)		3/295 (1%)		1/295 (0.3%)		8/295 (2.7%)
General disorders
Oedema peripheral	2/230 (0.9%)		4/232 (1.7%)		7/295 (2.4%)		10/295 (3.4%)		3/295 (1%)
Infections and infestations
Bronchitis	6/230 (2.6%)		5/232 (2.2%)		2/295 (0.7%)		4/295 (1.4%)		3/295 (1%)
Influenza	5/230 (2.2%)		6/232 (2.6%)		4/295 (1.4%)		3/295 (1%)		3/295 (1%)
Nasopharyngitis	2/230 (0.9%)		4/232 (1.7%)		10/295 (3.4%)		13/295 (4.4%)		9/295 (3.1%)
Sinusitis	5/230 (2.2%)		5/232 (2.2%)		7/295 (2.4%)		3/295 (1%)		4/295 (1.4%)
Upper respiratory tract infection	10/230 (4.3%)		10/232 (4.3%)		10/295 (3.4%)		10/295 (3.4%)		12/295 (4.1%)
Urinary tract infection	8/230 (3.5%)		5/232 (2.2%)		6/295 (2%)		11/295 (3.7%)		5/295 (1.7%)
Injury, poisoning and procedural complications
Fall	3/230 (1.3%)		3/232 (1.3%)		6/295 (2%)		5/295 (1.7%)		7/295 (2.4%)
Musculoskeletal and connective tissue disorders
Arthralgia	4/230 (1.7%)		9/232 (3.9%)		26/295 (8.8%)		31/295 (10.5%)		4/295 (1.4%)
Joint swelling	2/230 (0.9%)		2/232 (0.9%)		7/295 (2.4%)		3/295 (1%)		0/295 (0%)
Muscle spasms	2/230 (0.9%)		0/232 (0%)		9/295 (3.1%)		7/295 (2.4%)		2/295 (0.7%)
Musculoskeletal pain	7/230 (3%)		2/232 (0.9%)		3/295 (1%)		4/295 (1.4%)		3/295 (1%)
Myalgia	0/230 (0%)		2/232 (0.9%)		7/295 (2.4%)		6/295 (2%)		3/295 (1%)
Pain in extremity	3/230 (1.3%)		6/232 (2.6%)		20/295 (6.8%)		19/295 (6.4%)		2/295 (0.7%)
Nervous system disorders
Dizziness	7/230 (3%)		5/232 (2.2%)		2/295 (0.7%)		4/295 (1.4%)		4/295 (1.4%)
Dysaesthesia	2/230 (0.9%)		2/232 (0.9%)		3/295 (1%)		8/295 (2.7%)		1/295 (0.3%)
Headache	9/230 (3.9%)		12/232 (5.2%)		7/295 (2.4%)		13/295 (4.4%)		11/295 (3.7%)
Hyperaesthesia	2/230 (0.9%)		2/232 (0.9%)		7/295 (2.4%)		12/295 (4.1%)		0/295 (0%)
Hypoaesthesia	6/230 (2.6%)		5/232 (2.2%)		9/295 (3.1%)		10/295 (3.4%)		8/295 (2.7%)
Paraesthesia	5/230 (2.2%)		11/232 (4.7%)		21/295 (7.1%)		38/295 (12.9%)		5/295 (1.7%)

Limitations/Caveats

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.

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.

Results Point of Contact

Name/Title	Pfizer ClinicalTrials.gov Call Center
Organization	Pfizer Inc.
Phone	1-800-718-1021
Email	ClinicalTrials.gov_Inquiries@pfizer.com

Responsible Party:

Pfizer

ClinicalTrials.gov Identifier:

NCT00876187

Other Study ID Numbers:

A4091012
CLBP-IV PH2B

First Posted:

Apr 6, 2009

Last Update Posted:

Jul 7, 2021

Last Verified:

Jun 1, 2021

A Study of Tanezumab in Adults With Chronic Low Back Pain

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Outcome Measure Data

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