NCT02528253: TANGO

A Phase 3 Study of Tanezumab for Chronic Low Back Pain

Completed Phase 3 Results posted Last updated 21 February 2020

What this trial tests

Phase 3 trial testing Placebo to Week 16; tanezumab 5mg SC in Low Back Pain in 1,832 participants. Completed in 20 December 2018.

Timeline

18 August 2015

Primary endpoint
17 October 2017

20 December 2018

Quick facts

Lead sponsor	Pfizer
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	1,832
Start date	18 August 2015
Primary completion	17 October 2017
Estimated completion	20 December 2018
Sites	262 locations across Denmark, France, Japan, Sweden, Hungary, South Korea, Canada, United States

Drugs / interventions tested

• Placebo to Week 16; tanezumab 5mg SC — full drug profile →
• Placebo to Week 16, tanezumab 10 mg SC — full drug profile →
• Tanezumab 5 mg SC — full drug profile →
• Tanezumab 10 mg SC — full drug profile →
• Tramadol PR oral — full drug profile →

Conditions studied

• Low Back Pain — all drugs for Low Back Pain →

Sponsor

Pfizer — full company profile →

Who can join

18 and older, any sex, with Low Back Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Average Low Back Pain Intensity (LBPI) Score for Tanezumab Versus (Vs) Placebo at Week 16 Primary · Baseline, Week 16

Average low back pain was assessed on an 11-point numeric rating scale (NRS) captured through an interactive response technology (IRT). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.

Group	Value	95% CI
Placebo	-2.68	± 0.15
Pooled Tanezumab 5 mg	-2.98	± 0.14
Pooled Tanezumab 10 mg	-3.08	± 0.14
Tramadol	-2.81	± 0.12

Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) at Week 16 for Tanezumab Versus (Vs) Placebo Secondary · Baseline, Week 16

The RMDQ is a self-administered, widely used health status measure index of how well participants with low back pain (LBP) are able to function with regard to daily activities. It measures pain and function, using 24 items describing limitations to everyday life that can be caused by LBP. The total score of the RMDQ from the total number of items checked ranged from 0 (no disability) to 24 (maximum disability), where higher scores indicated greater disability.

Group	Value	95% CI
Placebo	-4.95	± 0.36
Pooled Tanezumab 5 mg	-6.27	± 0.35
Pooled Tanezumab 10 mg	-6.69	± 0.35
Tramadol	-5.21	± 0.30

Change From Baseline in Average Low Back Pain Intensity (LBPI) Score for Tanezumab Versus (Vs) Tramadol at Week 16 Secondary · Baseline, Week 16

Average LBP was assessed on an 11-point NRS captured through an IRT. Participants described their average LBP during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.

Group	Value	95% CI
Placebo	-2.68	± 0.15
Pooled Tanezumab 5 mg	-2.98	± 0.14
Pooled Tanezumab 10 mg	-3.08	± 0.14
Tramadol	-2.81	± 0.12

Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56 Secondary · Baseline, Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56

Average LBP was assessed on an 11-point NRS captured through an IRT. The LBPI score was captured once daily from baseline up to week 16, and once weekly from week 16 to week 64. Participants described their average LBP during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.

Change at Week 2

Group	Value	95% CI
Placebo	-1.17	± 0.09
Pooled Tanezumab 5 mg	-1.54	± 0.09
Pooled Tanezumab 10 mg	-1.59	± 0.09
Tramadol	-1.36	± 0.08

Change at Week 4

Group	Value	95% CI
Placebo	-1.75	± 0.12
Pooled Tanezumab 5 mg	-2.24	± 0.12
Pooled Tanezumab 10 mg	-2.43	± 0.12
Tramadol	-1.99	± 0.10

Change at Week 8

Group	Value	95% CI
Placebo	-2.10	± 0.13
Pooled Tanezumab 5 mg	-2.64	± 0.13
Pooled Tanezumab 10 mg	-2.79	± 0.13
Tramadol	-2.43	± 0.11

Change at Week 12

Group	Value	95% CI
Placebo	-2.54	± 0.13
Pooled Tanezumab 5 mg	-2.92	± 0.13
Pooled Tanezumab 10 mg	-3.12	± 0.13
Tramadol	-2.74	± 0.11

Change at Week 24

Group	Value	95% CI
Pooled Tanezumab 5 mg	-2.76	± 0.16
Pooled Tanezumab 10 mg	-2.92	± 0.16
Tramadol	-2.64	± 0.14

Change at Week 32

Group	Value	95% CI
Pooled Tanezumab 5 mg	-2.74	± 0.17
Pooled Tanezumab 10 mg	-2.75	± 0.16
Tramadol	-2.52	± 0.14

Change at Week 40

Group	Value	95% CI
Pooled Tanezumab 5 mg	-2.64	± 0.17
Pooled Tanezumab 10 mg	-2.67	± 0.17
Tramadol	-2.49	± 0.14

Change at Week 48

Group	Value	95% CI
Pooled Tanezumab 5 mg	-2.58	± 0.17
Pooled Tanezumab 10 mg	-2.62	± 0.17
Tramadol	-2.43	± 0.15

Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 64 Secondary · Baseline, Week 64

Average LBP was assessed on an 11-point NRS captured through an IRT. The LBPI score was captured once a week for week 64. Participants described their average LBP during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.

Baseline

Group	Value	95% CI
Placebo Followed by Tanezumab 5 mg	7.16	± 1.15
Placebo Followed by Tanezumab 10 mg	7.23	± 1.09
Pooled Tanezumab 5 mg	7.25	± 1.08
Pooled Tanezumab 10 mg	7.18	± 1.13
Tramadol	7.17	± 1.16

Change at Week 64

Group	Value	95% CI
Placebo Followed by Tanezumab 5 mg	-4.36	± 2.28
Placebo Followed by Tanezumab 10 mg	-4.32	± 2.01
Pooled Tanezumab 5 mg	-4.04	± 2.15
Pooled Tanezumab 10 mg	-3.71	± 2.39
Tramadol	-4.08	± 2.12

Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Total Score at Weeks 2, 4, 8, 16 (for Tanezumab vs Tramadol) 24, 32, 40, 48 and 56 Secondary · Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56

The RMDQ is a self-administered, widely used health status measure index of how well participants with LBP are able to function with regard to daily activities. It measures pain and function, using 24 items describing limitations to everyday life that can be caused by LBP. The total score of the RMDQ is the total number of items checked ranging from 0 (no disability) to 24 (maximum disability), where higher scores indicated greater disability. Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg

Change at Week 2

Group	Value	95% CI
Placebo	-2.46	± 0.26
Pooled Tanezumab 5 mg	-3.30	± 0.25
Pooled Tanezumab 10 mg	-3.84	± 0.26
Tramadol	-2.74	± 0.21

Change at Week 4

Group	Value	95% CI
Placebo	-3.37	± 0.29
Pooled Tanezumab 5 mg	-4.58	± 0.29
Pooled Tanezumab 10 mg	-5.32	± 0.29
Tramadol	-3.67	± 0.25

Change at Week 8

Group	Value	95% CI
Placebo	-3.90	± 0.31
Pooled Tanezumab 5 mg	-5.27	± 0.31
Pooled Tanezumab 10 mg	-5.85	± 0.31
Tramadol	-4.51	± 0.27

Change at Week 16

Group	Value	95% CI
Placebo	-4.95	± 0.36
Pooled Tanezumab 5 mg	-6.27	± 0.35
Pooled Tanezumab 10 mg	-6.69	± 0.35
Tramadol	-5.21	± 0.30

Change at Week 24

Group	Value	95% CI
Pooled Tanezumab 5 mg	-5.57	± 0.41
Pooled Tanezumab 10 mg	-5.92	± 0.41
Tramadol	-4.59	± 0.35

Change at Week 32

Group	Value	95% CI
Pooled Tanezumab 5 mg	-5.46	± 0.42
Pooled Tanezumab 10 mg	-5.71	± 0.42
Tramadol	-4.74	± 0.35

Change at Week 40

Group	Value	95% CI
Pooled Tanezumab 5 mg	-5.12	± 0.43
Pooled Tanezumab 10 mg	-5.24	± 0.44
Tramadol	-4.53	± 0.36

Change at Week 48

Group	Value	95% CI
Pooled Tanezumab 5 mg	-4.92	± 0.43
Pooled Tanezumab 10 mg	-5.14	± 0.43
Tramadol	-4.44	± 0.37

Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 64 and 80: Observed Data Secondary · Baseline, Weeks 64 and 80

The RMDQ is a self-administered, widely used health status measure index of how well participants with LBP are able to function with regard to daily activities. It measures pain and function, using 24 items describing limitations to everyday life that can be caused by LBP. The total score of the RMDQ is the total number of items checked ranging from 0 (no disability) to 24 (maximum disability), where higher scores indicated greater disability.

Baseline

Group	Value	95% CI
Placebo Followed by Tanezumab 5 mg	14.64	± 5.26
Placebo Followed by Tanezumab 10 mg	14.98	± 5.03
Pooled Tanezumab 5 mg	15.02	± 5.21
Pooled Tanezumab 10 mg	15.06	± 4.92
Tramadol	15.10	± 5.11

Change at Week 64

Group	Value	95% CI
Placebo Followed by Tanezumab 5 mg	-8.35	± 6.72
Placebo Followed by Tanezumab 10 mg	-8.71	± 5.78
Pooled Tanezumab 5 mg	-8.72	± 6.32
Pooled Tanezumab 10 mg	-7.64	± 5.96
Tramadol	-8.87	± 5.88

Change at Week 80

Group	Value	95% CI
Placebo Followed by Tanezumab 5 mg	-8.03	± 7.00
Placebo Followed by Tanezumab 10 mg	-7.27	± 6.79
Pooled Tanezumab 5 mg	-8.80	± 6.68
Pooled Tanezumab 10 mg	-7.13	± 5.99
Tramadol	-8.35	± 6.01

Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Secondary · Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56

PGA of LBP was assessed by asking a question to participants: "Considering all the ways your low back pain affects you, how are you doing today?" Participants responded on a 5 point Likert scale ranging from 1-5, using IRT, where 1=very good (asymptomatic and no limitation of normal activities); 2=good (mild symptoms and no limitation of normal activities); 3=fair (moderate symptoms and limitation of some normal activities); 4=poor (severe symptoms and inability to carry out most normal activities); and 5=very poor (very severe symptoms which are intolerable and inability to carry out all norm

Change at Week 2

Group	Value	95% CI
Placebo	-0.54	± 0.04
Pooled Tanezumab 5 mg	-0.62	± 0.04
Pooled Tanezumab 10 mg	-0.67	± 0.04
Tramadol	-0.54	± 0.03

Change at Week 4

Group	Value	95% CI
Placebo	-0.64	± 0.04
Pooled Tanezumab 5 mg	-0.82	± 0.04
Pooled Tanezumab 10 mg	-0.86	± 0.04
Tramadol	-0.66	± 0.04

Change at Week 8

Group	Value	95% CI
Placebo	-0.69	± 0.05
Pooled Tanezumab 5 mg	-0.82	± 0.05
Pooled Tanezumab 10 mg	-0.89	± 0.05
Tramadol	-0.76	± 0.04

Change at Week 16

Group	Value	95% CI
Placebo	-0.86	± 0.05
Pooled Tanezumab 5 mg	-0.98	± 0.05
Pooled Tanezumab 10 mg	-1.02	± 0.05
Tramadol	-0.85	± 0.04

Change at Week 24

Group	Value	95% CI
Pooled Tanezumab 5 mg	-0.83	± 0.06
Pooled Tanezumab 10 mg	-0.82	± 0.06
Tramadol	-0.74	± 0.05

Change at Week 32

Group	Value	95% CI
Pooled Tanezumab 5 mg	-0.80	± 0.06
Pooled Tanezumab 10 mg	-0.79	± 0.06
Tramadol	-0.74	± 0.05

Change at Week 40

Group	Value	95% CI
Pooled Tanezumab 5 mg	-0.80	± 0.06
Pooled Tanezumab 10 mg	-0.75	± 0.06
Tramadol	-0.70	± 0.05

Change at Week 48

Group	Value	95% CI
Pooled Tanezumab 5 mg	-0.74	± 0.07
Pooled Tanezumab 10 mg	-0.72	± 0.07
Tramadol	-0.66	± 0.06

Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain at Week 64: Observed Data Secondary · Baseline, Week 64

PGA of LBP was assessed by asking a question to participants: "Considering all the ways your low back pain affects you, how are you doing today?" Participants responded on a 5 point Likert scale ranging from 1-5, using IRT, where 1=very good (asymptomatic and no limitation of normal activities); 2=good (mild symptoms and no limitation of normal activities); 3=fair (moderate symptoms and limitation of some normal activities); 4=poor (severe symptoms and inability to carry out most normal activities); and 5=very poor (very severe symptoms which are intolerable and inability to carry out all norm

Baseline

Group	Value	95% CI
Placebo Followed by Tanezumab 5 mg	3.47	± 0.65
Placebo Followed by Tanezumab 10 mg	3.49	± 0.60
Pooled Tanezumab 5 mg	3.47	± 0.61
Pooled Tanezumab 10 mg	3.53	± 0.63
Tramadol	3.50	± 0.63

Change at Week 64

Group	Value	95% CI
Placebo Followed by Tanezumab 5 mg	-1.21	± 1.02
Placebo Followed by Tanezumab 10 mg	-1.16	± 0.86
Pooled Tanezumab 5 mg	-1.03	± 0.98
Pooled Tanezumab 10 mg	-1.01	± 0.92
Tramadol	-1.14	± 0.88

Percentage of Participants With Cumulative Percent Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF) Secondary · Baseline, Weeks 16, 24 and 56

Average LBP was assessed on an 11-point NRS captured through an IRT. LBPI score was captured once a week for week 64. Participants described their average LBP during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.Percentage of participants with cumulative reduction (as percent) (greater than \[\>\] 0%; \>= 10, 20, 30, 40, 50, 60, 70, 80, 90 and equals to \[=\] 100 %) in LBPI from baseline to weeks 16, 24 and 56 were reported, participants (%) are reported more than once in categories specified.Missing data was impute

Week 16: >0%

Group	Value	95% CI
Placebo	80.8
Pooled Tanezumab 5 mg	85.3
Pooled Tanezumab 10 mg	87.2
Tramadol	80.8

Week 16: >=10%

Group	Value	95% CI
Placebo	73.6
Pooled Tanezumab 5 mg	79.1
Pooled Tanezumab 10 mg	82.1
Tramadol	74.5

Week 16: >=20%

Group	Value	95% CI
Placebo	64.8
Pooled Tanezumab 5 mg	72.5
Pooled Tanezumab 10 mg	73.2
Tramadol	64.8

Week 16: >=30%

Group	Value	95% CI
Placebo	55.7
Pooled Tanezumab 5 mg	64.6
Pooled Tanezumab 10 mg	65.4
Tramadol	57.9

Week 16: >=40%

Group	Value	95% CI
Placebo	46.8
Pooled Tanezumab 5 mg	52.1
Pooled Tanezumab 10 mg	56.3
Tramadol	49.9

Week 16: >=50%

Group	Value	95% CI
Placebo	37.2
Pooled Tanezumab 5 mg	43.2
Pooled Tanezumab 10 mg	46.2
Tramadol	42.8

Week 16: >=60%

Group	Value	95% CI
Placebo	29.3
Pooled Tanezumab 5 mg	33.4
Pooled Tanezumab 10 mg	36.9
Tramadol	32.2

Week 16: >=70%

Group	Value	95% CI
Placebo	18.5
Pooled Tanezumab 5 mg	21.6
Pooled Tanezumab 10 mg	25.1
Tramadol	20.2

Percentage of Participants Achieving Average LBPI Reduction of >=30 Percent(%), >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF) Secondary · Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56

Average LBP was assessed on an 11-point NRS captured through an IRT. The LBPI score was captured once a week for week 64. Participants described their average LBP during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants with reduction in LBPI of at least (\>=) 30%, 50%, 70% and 90% at weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56 compared to baseline were classified as responders to LBPI and are reported here, participants (%) are reported more than once in categories specified.Pre-specified i

Week 2: At least 30% reduction

Group	Value	95% CI
Placebo	20.8
Pooled Tanezumab 5 mg	31.3
Pooled Tanezumab 10 mg	31.8
Tramadol	28.6

Week 2: At least 50% reduction

Group	Value	95% CI
Placebo	8.9
Pooled Tanezumab 5 mg	13.1
Pooled Tanezumab 10 mg	14.8
Tramadol	11.2

Week 2: At least 70% reduction

Group	Value	95% CI
Placebo	2.7
Pooled Tanezumab 5 mg	5.2
Pooled Tanezumab 10 mg	5.7
Tramadol	3.3

Week 2: At least 90% reduction

Group	Value	95% CI
Placebo	1.0
Pooled Tanezumab 5 mg	1.0
Pooled Tanezumab 10 mg	1.7
Tramadol	0.8

Week 4: At least 30% reduction

Group	Value	95% CI
Placebo	35.6
Pooled Tanezumab 5 mg	47.5
Pooled Tanezumab 10 mg	53.2
Tramadol	42.1

Week 4: At least 50% reduction

Group	Value	95% CI
Placebo	19.1
Pooled Tanezumab 5 mg	26.1
Pooled Tanezumab 10 mg	30.8
Tramadol	23.0

Week 4: At least 70% reduction

Group	Value	95% CI
Placebo	7.4
Pooled Tanezumab 5 mg	12.8
Pooled Tanezumab 10 mg	17.7
Tramadol	9.1

Week 4: At least 90% reduction

Group	Value	95% CI
Placebo	2.7
Pooled Tanezumab 5 mg	2.7
Pooled Tanezumab 10 mg	3.7
Tramadol	2.5

Percentage of Participants Achieving RMDQ Reduction of >=30%, >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF) Secondary · Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56

RMDQ: health status measure index of how well participants with LBP are able to function with regard to daily activities. Measures pain and function using 24 items describing limitations to everyday life. Total score of RMDQ is total number of items checked ranging from 0=no disability to 24=maximum disability, higher scores=greater disability. Percentage of participants with reduction in LBPI of at least (\>=) 30, 50, 70 and 90% at specified weeks compared to baseline were classified as responders to LBPI and are reported here. Pre-specified intent of study for efficacy data up to W16 was to

Week 2: At least 30% reduction

Group	Value	95% CI
Placebo	24.1
Pooled Tanezumab 5 mg	32.3
Pooled Tanezumab 10 mg	38.3
Tramadol	29.3

Week 2: At least 50% reduction

Group	Value	95% CI
Placebo	13.5
Pooled Tanezumab 5 mg	20.0
Pooled Tanezumab 10 mg	21.4
Tramadol	16.9

Week 2: At least 70% reduction

Group	Value	95% CI
Placebo	5.7
Pooled Tanezumab 5 mg	10.6
Pooled Tanezumab 10 mg	10.3
Tramadol	6.6

Week 2: At least 90% reduction

Group	Value	95% CI
Placebo	1.7
Pooled Tanezumab 5 mg	4.2
Pooled Tanezumab 10 mg	5.4
Tramadol	2.3

Week 4: At least 30% reduction

Group	Value	95% CI
Placebo	34.5
Pooled Tanezumab 5 mg	46.2
Pooled Tanezumab 10 mg	50.4
Tramadol	39.7

Week 4: At least 50% reduction

Group	Value	95% CI
Placebo	19.2
Pooled Tanezumab 5 mg	30.9
Pooled Tanezumab 10 mg	34.2
Tramadol	25.3

Week 4: At least 70% reduction

Group	Value	95% CI
Placebo	10.1
Pooled Tanezumab 5 mg	17.5
Pooled Tanezumab 10 mg	21.1
Tramadol	10.9

Week 4: At least 90% reduction

Group	Value	95% CI
Placebo	4.2
Pooled Tanezumab 5 mg	7.9
Pooled Tanezumab 10 mg	9.6
Tramadol	3.1

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline up to Week 80. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo (Week 16)

Serious: 7/215 (3%)

Deaths: 1/215

Safety Evaluation: Tanezumab 5 mg

Serious: 21/506 (4%)

Deaths: 2/506

Safety Evaluation: Tanezumab 10 mg

Serious: 37/502 (7%)

Deaths: 2/502

Tramadol

Serious: 25/602 (4%)

Deaths: 1/602

Serious adverse events (87 terms)

Reaction	System	Placebo (Week 16)	Safety Evaluation: Tanezum…	Safety Evaluation: Tanezum…	Tramadol
Rapidly progressive osteoarthritis	Musculoskeletal and connective tissue disorders	—	—	—	—
Osteoarthritis	Musculoskeletal and connective tissue disorders	—	—	—	—
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	—	—	—	—
Vertigo	Ear and labyrinth disorders	—	—	—	—
Road traffic accident	Injury, poisoning and procedural complications	—	—	—	—
Lumbar radiculopathy	Nervous system disorders	—	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—	—
Cardiac failure	Cardiac disorders	—	—	—	—
Cardiac failure congestive	Cardiac disorders	—	—	—	—
Coronary artery disease	Cardiac disorders	—	—	—	—
Myocardial infarction	Cardiac disorders	—	—	—	—
Palpitations	Cardiac disorders	—	—	—	—
Supraventricular tachycardia	Cardiac disorders	—	—	—	—
Pupils unequal	Eye disorders	—	—	—	—
Uveitis	Eye disorders	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—
Anal fistula	Gastrointestinal disorders	—	—	—	—
Colitis	Gastrointestinal disorders	—	—	—	—
Colitis ischaemic	Gastrointestinal disorders	—	—	—	—
Gastrointestinal haemorrhage	Gastrointestinal disorders	—	—	—	—
Hiatus hernia	Gastrointestinal disorders	—	—	—	—
Large intestine perforation	Gastrointestinal disorders	—	—	—	—
Oesophageal rupture	Gastrointestinal disorders	—	—	—	—
Pancreatitis	Gastrointestinal disorders	—	—	—	—
Chest pain	General disorders	—	—	—	—

Other adverse events (11 terms — click to expand)

Reaction	System	Placebo (Week 16)	Safety Evaluation: Tanezum…	Safety Evaluation: Tanezum…	Tramadol
Nausea	Gastrointestinal disorders	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—
Somnolence	Nervous system disorders	—	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—	—

Most-reported serious reactions: Rapidly progressive osteoarthritis, Osteoarthritis, Rotator cuff syndrome, Vertigo, Road traffic accident, Lumbar radiculopathy, Atrial fibrillation, Cardiac failure.

Data from ClinicalTrials.gov NCT02528253 adverse events section.

Sponsor's own description

This study will investigate the efficacy and safety of tanezumab 5 mg and 10 mg administered by subcutaneous injection seven times at 8 week intervals (56 weeks). The primary objective of this study is to evaluate the effectiveness of tanezumab 10 mg and 5 mg compared to placebo for the treatment of chronic low back pain. Secondary objectives are to evaluate the long-term safety and effectiveness of tanezumab 10 mg and 5 mg compared to placebo for the treatment of chronic low back pain. In addition, the study will evaluate the effectiveness and long term safety profile of tanezumab treatment for chronic low back pain compared to tramadol Prolonged Release (PR), a medication commonly utilized for the treatment of chronic low back pain.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Antibodies to watch in 2017.
   Reichert JM. · · 2017 · cited 194× · PMID 27960628 · DOI 10.1080/19420862.2016.1269580
2. Antibodies to watch in 2018.
   Kaplon H, Reichert JM. · · 2018 · cited 179× · PMID 29300693 · DOI 10.1080/19420862.2018.1415671
3. Treatment of chronic low back pain - new approaches on the horizon.
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