NCT00985621

Tanezumab In Osteoarthritis Of The Hip Or Knee

Terminated Phase 3 Results posted Last updated 14 May 2021

What this trial tests

Phase 3 trial testing tanezumab 10 mg in Osteoarthritis in 614 participants. Terminated before completion.

Timeline

30 October 2009

Primary endpoint
13 December 2010

4 February 2011

Quick facts

Lead sponsor	Pfizer
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	614
Start date	30 October 2009
Primary completion	13 December 2010
Estimated completion	4 February 2011
Sites	112 locations across Denmark, Austria, Sweden, Germany, Poland, United States, Spain

Drugs / interventions tested

• tanezumab 10 mg — full drug profile →
• tanezumab 5 mg — full drug profile →
• oxycodone (oxycodone) — full drug profile →
• placebo

Conditions studied

• Osteoarthritis — all drugs for Osteoarthritis →

Sponsor

Pfizer — full company profile →

Who can join

Adults 18 to 75, any sex, with Osteoarthritis. 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 Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: ITT Population Primary · Baseline, Week 8

The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis (OA) in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on a numerical rating scale (NRS) of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.

Baseline

Group	Value	95% CI
Placebo	7.75	± 1.21
Tanezumab 5 mg	7.85	± 1.27
Tanezumab 10 mg	7.63	± 1.30
Oxycodone CR	7.85	± 1.27

Change at Week 8

Group	Value	95% CI
Placebo	-2.74	± 2.26
Tanezumab 5 mg	-3.71	± 2.49
Tanezumab 10 mg	-3.63	± 2.62
Oxycodone CR	-2.71	± 2.36

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: Modified Intent-to-Treat (mITT) Population Primary · Baseline, Week 8

The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on an NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.

Baseline

Group	Value	95% CI
Placebo	7.75	± 1.20
Tanezumab 5 mg	7.87	± 1.26
Tanezumab 10 mg	7.64	± 1.31
Oxycodone CR	7.86	± 1.27

Change at Week 8

Group	Value	95% CI
Placebo	-2.58	± 2.30
Tanezumab 5 mg	-3.42	± 2.64
Tanezumab 10 mg	-3.01	± 2.69
Oxycodone CR	-2.41	± 2.29

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 12, and 16: ITT Population Secondary · Baseline, Weeks 2, 4, 12, and 16

The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on an NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.

Change at Week 2

Group	Value	95% CI
Placebo	-2.12	± 1.91
Tanezumab 5 mg	-2.47	± 2.23
Tanezumab 10 mg	-2.29	± 2.25
Oxycodone CR	-2.31	± 2.09

Change at Week 4

Group	Value	95% CI
Placebo	-2.55	± 2.09
Tanezumab 5 mg	-3.56	± 2.54
Tanezumab 10 mg	-3.45	± 2.62
Oxycodone CR	-2.87	± 2.25

Change at Week 12

Group	Value	95% CI
Placebo	-2.85	± 2.37
Tanezumab 5 mg	-3.82	± 2.62
Tanezumab 10 mg	-3.64	± 2.60
Oxycodone CR	-2.80	± 2.41

Change at Week 16

Group	Value	95% CI
Placebo	-2.95	± 2.46
Tanezumab 5 mg	-3.80	± 2.60
Tanezumab 10 mg	-3.65	± 2.51
Oxycodone CR	-2.79	± 2.39

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 12, and 16: mITT Population Secondary · Baseline, Weeks 2, 4, 12, and 16

The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on an NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.

Change at Week 2

Group	Value	95% CI
Placebo	-1.98	± 1.92
Tanezumab 5 mg	-2.34	± 2.25
Tanezumab 10 mg	-2.05	± 2.18
Oxycodone CR	-2.08	± 2.17

Change at Week 4

Group	Value	95% CI
Placebo	-2.37	± 2.15
Tanezumab 5 mg	-3.27	± 2.58
Tanezumab 10 mg	-2.85	± 2.68
Oxycodone CR	-2.48	± 2.29

Change at Week 12

Group	Value	95% CI
Placebo	-2.69	± 2.42
Tanezumab 5 mg	-3.58	± 2.76
Tanezumab 10 mg	-3.06	± 2.69
Oxycodone CR	-2.57	± 2.37

Change at Week 16

Group	Value	95% CI
Placebo	-2.85	± 2.55
Tanezumab 5 mg	-3.63	± 2.77
Tanezumab 10 mg	-3.16	± 2.68
Oxycodone CR	-2.58	± 2.35

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population Secondary · Baseline, Week 2, 4, 8, 12, and 16

The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 17 individual questions scored on an NRS of 0 to 10, where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 to 10, where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living.

Baseline

Group	Value	95% CI
Placebo	7.19	± 1.50
Tanezumab 5 mg	7.30	± 1.58
Tanezumab 10 mg	7.04	± 1.54
Oxycodone CR	7.25	± 1.53

Change at Week 2

Group	Value	95% CI
Placebo	-1.51	± 1.73
Tanezumab 5 mg	-2.16	± 2.30
Tanezumab 10 mg	-1.95	± 2.08
Oxycodone CR	-1.71	± 1.94

Change at Week 4

Group	Value	95% CI
Placebo	-1.89	± 1.96
Tanezumab 5 mg	-3.04	± 2.59
Tanezumab 10 mg	-2.94	± 2.61
Oxycodone CR	-2.10	± 2.20

Change at Week 8

Group	Value	95% CI
Placebo	-2.01	± 2.09
Tanezumab 5 mg	-3.18	± 2.49
Tanezumab 10 mg	-3.08	± 2.50
Oxycodone CR	-2.14	± 2.30

Change at Week 12

Group	Value	95% CI
Placebo	-2.17	± 2.26
Tanezumab 5 mg	-3.34	± 2.62
Tanezumab 10 mg	-3.09	± 2.45
Oxycodone CR	-2.17	± 2.28

Change at Week 16

Group	Value	95% CI
Placebo	-2.26	± 2.37
Tanezumab 5 mg	-3.27	± 2.61
Tanezumab 10 mg	-3.10	± 2.42
Oxycodone CR	-2.18	± 2.26

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 16: mITT Population Secondary · Baseline, Weeks 2, 4, 8, 12, and 16

The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 17 individual questions scored on an NRS of 0 to 10, where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 to 10, where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living.

Baseline

Group	Value	95% CI
Placebo	7.17	± 1.51
Tanezumab 5 mg	7.32	± 1.59
Tanezumab 10 mg	7.05	± 1.54
Oxycodone CR	7.26	± 1.53

Change at Week 2

Group	Value	95% CI
Placebo	-1.41	± 1.73
Tanezumab 5 mg	-2.00	± 2.32
Tanezumab 10 mg	-1.73	± 1.99
Oxycodone CR	-1.56	± 1.94

Change at Week 4

Group	Value	95% CI
Placebo	-1.73	± 2.00
Tanezumab 5 mg	-2.80	± 2.69
Tanezumab 10 mg	-2.47	± 2.59
Oxycodone CR	-1.83	± 2.16

Change at Week 8

Group	Value	95% CI
Placebo	-1.87	± 2.03
Tanezumab 5 mg	-3.00	± 2.68
Tanezumab 10 mg	-2.62	± 2.58
Oxycodone CR	-1.87	± 2.24

Change at Week 12

Group	Value	95% CI
Placebo	-2.03	± 2.21
Tanezumab 5 mg	-3.19	± 2.78
Tanezumab 10 mg	-2.65	± 2.60
Oxycodone CR	-1.95	± 2.24

Change at Week 16

Group	Value	95% CI
Placebo	-2.20	± 2.38
Tanezumab 5 mg	-3.22	± 2.78
Tanezumab 10 mg	-2.77	± 2.64
Oxycodone CR	-1.97	± 2.21

Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, and 16: ITT Population Secondary · Baseline, Weeks 2, 4, 8, 12, and 16

PGA: Participants answered the following question: "Considering all the ways the OA in your index (knee/hip) affects you, how are you doing today?" Participants rated their condition by using a 5-point Likert scale: 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 normal activi

Baseline

Group	Value	95% CI
Placebo	3.60	± 0.68
Tanezumab 5 mg	3.58	± 0.65
Tanezumab 10 mg	3.57	± 0.68
Oxycodone CR	3.59	± 0.62

Change at Week 2

Group	Value	95% CI
Placebo	-0.49	± 0.88
Tanezumab 5 mg	-0.71	± 0.90
Tanezumab 10 mg	-0.63	± 0.78
Oxycodone CR	-0.54	± 0.76

Change at Week 4

Group	Value	95% CI
Placebo	-0.57	± 0.85
Tanezumab 5 mg	-0.99	± 0.96
Tanezumab 10 mg	-0.99	± 0.84
Oxycodone CR	-0.64	± 0.78

Change at Week 8

Group	Value	95% CI
Placebo	-0.56	± 0.86
Tanezumab 5 mg	-0.93	± 0.97
Tanezumab 10 mg	-1.01	± 0.97
Oxycodone CR	-0.58	± 0.78

Change at Week 12

Group	Value	95% CI
Placebo	-0.64	± 0.88
Tanezumab 5 mg	-0.99	± 0.97
Tanezumab 10 mg	-1.07	± 0.96
Oxycodone CR	-0.59	± 0.86

Change at Week 16

Group	Value	95% CI
Placebo	-0.63	± 0.87
Tanezumab 5 mg	-0.96	± 0.97
Tanezumab 10 mg	-1.07	± 0.95
Oxycodone CR	-0.59	± 0.83

Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, and 16: mITT Population Secondary · Baseline, Weeks 2, 4, 8, 12, and 16

PGA: Participants answered the following question: "Considering all the ways the OA in your index (knee/hip) affects you, how are you doing today?" Participants rated their condition by using a 5-point Likert scale: 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 normal activi

Baseline

Group	Value	95% CI
Placebo	3.59	± 0.68
Tanezumab 5 mg	3.59	± 0.65
Tanezumab 10 mg	3.56	± 0.68
Oxycodone CR	3.59	± 0.62

Change at Week 2

Group	Value	95% CI
Placebo	-0.47	± 0.88
Tanezumab 5 mg	-0.71	± 0.89
Tanezumab 10 mg	-0.55	± 0.76
Oxycodone CR	-0.49	± 0.74

Change at Week 4

Group	Value	95% CI
Placebo	-0.50	± 0.86
Tanezumab 5 mg	-0.94	± 0.95
Tanezumab 10 mg	-0.82	± 0.82
Oxycodone CR	-0.54	± 0.75

Change at Week 8

Group	Value	95% CI
Placebo	-0.55	± 0.91
Tanezumab 5 mg	-0.93	± 0.98
Tanezumab 10 mg	-0.81	± 0.84
Oxycodone CR	-0.52	± 0.74

Change at Week 12

Group	Value	95% CI
Placebo	-0.63	± 0.93
Tanezumab 5 mg	-0.98	± 0.96
Tanezumab 10 mg	-0.83	± 0.84
Oxycodone CR	-0.56	± 0.81

Change at Week 16

Group	Value	95% CI
Placebo	-0.67	± 0.94
Tanezumab 5 mg	-0.97	± 0.97
Tanezumab 10 mg	-0.87	± 0.83
Oxycodone CR	-0.55	± 0.79

Number of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response at Weeks 2, 4, 8, 12, and 16: ITT Population Secondary · Weeks 2, 4, 8, 12, and 16

OMERACT-OARSI response: greater than or equal to (\>=) 50 percent (%) improvement from baseline and absolute change from baseline of \>=2 units at Week of interest in WOMAC pain or physical function subscales, or at least 2 of the following 3 being true: \>=20% improvement from baseline and absolute change from baseline of \>=1 unit at Week of interest in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis (score: 1-5, higher score=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score: 0-10, higher score=hi

Week 2

Group	Value	95% CI
Placebo	70
Tanezumab 5 mg	89
Tanezumab 10 mg	82
Oxycodone CR	81

Week 4

Group	Value	95% CI
Placebo	87
Tanezumab 5 mg	117
Tanezumab 10 mg	107
Oxycodone CR	97

Week 8

Group	Value	95% CI
Placebo	81
Tanezumab 5 mg	120
Tanezumab 10 mg	105
Oxycodone CR	93

Week 12

Group	Value	95% CI
Placebo	83
Tanezumab 5 mg	120
Tanezumab 10 mg	110
Oxycodone CR	100

Week 16

Group	Value	95% CI
Placebo	84
Tanezumab 5 mg	120
Tanezumab 10 mg	112
Oxycodone CR	95

Number of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response at Weeks 2, 4, 8, 12, and 16: mITT Population Secondary · Weeks 2, 4, 8, 12, and 16

OMERACT-OARSI response: \>=50 percent (%) improvement from baseline and absolute change from baseline of \>=2 units at Week of interest in WOMAC pain or physical function subscales, or at least 2 of the following 3 being true: \>=20% improvement from baseline and absolute change from baseline of \>=1 unit at Week of interest in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis (score: 1-5, higher score=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score: 0-10, higher score=higher pain/difficulty).

Week 2

Group	Value	95% CI
Placebo	64
Tanezumab 5 mg	79
Tanezumab 10 mg	74
Oxycodone CR	70

Week 4

Group	Value	95% CI
Placebo	76
Tanezumab 5 mg	105
Tanezumab 10 mg	87
Oxycodone CR	83

Week 8

Group	Value	95% CI
Placebo	78
Tanezumab 5 mg	108
Tanezumab 10 mg	86
Oxycodone CR	80

Week 12

Group	Value	95% CI
Placebo	80
Tanezumab 5 mg	110
Tanezumab 10 mg	89
Oxycodone CR	87

Week 16

Group	Value	95% CI
Placebo	84
Tanezumab 5 mg	111
Tanezumab 10 mg	93
Oxycodone CR	87

Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population Secondary · Weeks 2, 4, 8, 12, and 16

The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on an NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.

Week 2: >=30% Reduction

Group	Value	95% CI
Placebo	59
Tanezumab 5 mg	75
Tanezumab 10 mg	66
Oxycodone CR	71

Week 2: >=50% Reduction

Group	Value	95% CI
Placebo	30
Tanezumab 5 mg	46
Tanezumab 10 mg	42
Oxycodone CR	33

Week 2: >=70% Reduction

Group	Value	95% CI
Placebo	10
Tanezumab 5 mg	23
Tanezumab 10 mg	15
Oxycodone CR	13

Week 2: >=90% Reduction

Group	Value	95% CI
Placebo	1
Tanezumab 5 mg	5
Tanezumab 10 mg	4
Oxycodone CR	5

Week 4: >=30% Reduction

Group	Value	95% CI
Placebo	72
Tanezumab 5 mg	98
Tanezumab 10 mg	97
Oxycodone CR	86

Week 4: >=50% Reduction

Group	Value	95% CI
Placebo	44
Tanezumab 5 mg	72
Tanezumab 10 mg	68
Oxycodone CR	48

Week 4: >=70% Reduction

Group	Value	95% CI
Placebo	15
Tanezumab 5 mg	48
Tanezumab 10 mg	47
Oxycodone CR	25

Week 4: >=90% Reduction

Group	Value	95% CI
Placebo	3
Tanezumab 5 mg	20
Tanezumab 10 mg	14
Oxycodone CR	7

Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 16: mITT Population Secondary · Weeks 2, 4, 8, 12, and 16

The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on an NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.

Week 2: >=30% Reduction

Group	Value	95% CI
Placebo	54
Tanezumab 5 mg	67
Tanezumab 10 mg	58
Oxycodone CR	63

Week 2: >=50% Reduction

Group	Value	95% CI
Placebo	28
Tanezumab 5 mg	41
Tanezumab 10 mg	37
Oxycodone CR	31

Week 2: >=70% Reduction

Group	Value	95% CI
Placebo	9
Tanezumab 5 mg	21
Tanezumab 10 mg	12
Oxycodone CR	13

Week 2: >=90% Reduction

Group	Value	95% CI
Placebo	1
Tanezumab 5 mg	4
Tanezumab 10 mg	2
Oxycodone CR	5

Week 4: >=30% Reduction

Group	Value	95% CI
Placebo	62
Tanezumab 5 mg	88
Tanezumab 10 mg	78
Oxycodone CR	74

Week 4: >=50% Reduction

Group	Value	95% CI
Placebo	39
Tanezumab 5 mg	61
Tanezumab 10 mg	55
Oxycodone CR	40

Week 4: >=70% Reduction

Group	Value	95% CI
Placebo	13
Tanezumab 5 mg	40
Tanezumab 10 mg	37
Oxycodone CR	22

Week 4: >=90% Reduction

Group	Value	95% CI
Placebo	3
Tanezumab 5 mg	17
Tanezumab 10 mg	9
Oxycodone CR	6

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 2/141 (1%)

Deaths: —

Tanezumab 5 mg

Serious: 4/161 (2%)

Deaths: —

Tanezumab 10 mg

Serious: 3/150 (2%)

Deaths: —

Oxycodone CR

Serious: 4/158 (3%)

Deaths: —

Serious adverse events (21 terms)

Reaction	System	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Oxycodone CR
Osteonecrosis	Musculoskeletal and connective tissue disorders	—	—	—	—
Colitis	Gastrointestinal disorders	—	—	—	—
Chest pain	General disorders	—	—	—	—
Drug ineffective	General disorders	—	—	—	—
Cholestasis	Hepatobiliary disorders	—	—	—	—
Clostridial infection	Infections and infestations	—	—	—	—
Pneumonia primary atypical	Infections and infestations	—	—	—	—
Clavicle fracture	Injury, poisoning and procedural complications	—	—	—	—
Drug exposure during pregnancy	Injury, poisoning and procedural complications	—	—	—	—
Fractured coccyx	Injury, poisoning and procedural complications	—	—	—	—
Hand fracture	Injury, poisoning and procedural complications	—	—	—	—
Head injury	Injury, poisoning and procedural complications	—	—	—	—
Limb injury	Injury, poisoning and procedural complications	—	—	—	—
Lumbar vertebral fracture	Injury, poisoning and procedural complications	—	—	—	—
Road traffic accident	Injury, poisoning and procedural complications	—	—	—	—
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	—	—	—	—
Osteoarthritis	Musculoskeletal and connective tissue disorders	—	—	—	—
Cervical myelopathy	Nervous system disorders	—	—	—	—
Guillain-Barre syndrome	Nervous system disorders	—	—	—	—
Unintended pregnancy	Pregnancy, puerperium and perinatal conditions	—	—	—	—
Suicide attempt	Psychiatric disorders	—	—	—	—

Other adverse events (23 terms — click to expand)

Reaction	System	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Oxycodone CR
Nausea	Gastrointestinal disorders	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Fatigue	General disorders	—	—	—	—
Somnolence	Nervous system disorders	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—
Paraesthesia	Nervous system disorders	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—	—
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—
Hypoaesthesia	Nervous system disorders	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Joint swelling	Musculoskeletal and connective tissue disorders	—	—	—	—

Most-reported serious reactions: Osteonecrosis, Colitis, Chest pain, Drug ineffective, Cholestasis, Clostridial infection, Pneumonia primary atypical, Clavicle fracture.

Data from ClinicalTrials.gov NCT00985621 adverse events section.

Sponsor's own description

The purpose of the study is to test the efficacy and safety of 2 doses of tanezumab compared to oxycodone CR and placebo in patients with osteoarthritis

Publications & conference data

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

1. The potential role of synovial cells in the progression and treatment of osteoarthritis.
   Zou Z, Li H, Yu K, Ma K, et al · · 2023 · cited 57× · PMID 37933282 · DOI 10.1002/exp.20220132
2. Pooled analysis of tanezumab efficacy and safety with subgroup analyses of phase III clinical trials in patients with osteoarthritis pain of the knee or hip.
   Tive L, Bello AE, Radin D, Schnitzer TJ, et al · · 2019 · cited 37× · PMID 30936738 · DOI 10.2147/jpr.s191297
3. Relative Efficacy and Safety of Tanezumab for Osteoarthritis: A Systematic Review and Meta-analysis of Randomized-Controlled Trials.
   Zhang B, Tian X, Qu Z, Liu J, et al · · 2021 · cited 7× · PMID 34608021 · DOI 10.1097/ajp.0000000000000986
4. Peripheral Nerve Safety of Nerve Growth Factor Inhibition by Tanezumab: Pooled Analyses of Phase III Clinical Studies in Over 5000 Patients with Osteoarthritis.
   Brown MT, Cornblath DR, Koltzenburg M, Gorson KC, et al · · 2023 · cited 4× · PMID 37460782 · DOI 10.1007/s40261-023-01286-3
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