Tanezumab In Osteoarthritis Of The Hip Or Knee

Sponsor

Pfizer (Industry)

Overall Status

Terminated

CT.gov ID

NCT00985621

Collaborator

(none)

614

Enrollment

112

Locations

Arms

15.2

Actual Duration (Months)

5.5

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis	Biological: tanezumab 10 mg Biological: tanezumab 5 mg Drug: oxycodone Other: placebo	Phase 3

Detailed Description

This study was terminated on 13 Dec 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues.

Study Design

Study Type:

Interventional

Actual Enrollment :

614 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO AND OXYCODONE CONTROLLED MULTI-CENTER STUDY OF THE EFFICACY AND SAFETY OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE OR HIP

Actual Study Start Date :

Oct 30, 2009

Actual Primary Completion Date :

Dec 13, 2010

Actual Study Completion Date :

Feb 4, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Biological: tanezumab 10 mg tanezumab 10 mg one dose at weeks 0 and 8
Experimental: 2	Biological: tanezumab 5 mg tanezumab 5 mg one dose at weeks 0 and 8
Active Comparator: 3	Drug: oxycodone oxycodone CR, 10-40 mg q12h
Placebo Comparator: 4	Other: placebo placebo

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 12, and 16: ITT Population [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 From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 12, and 16: mITT Population [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 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 [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.
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 [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.
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, and 16: ITT Population [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 activities). Higher score indicated severe condition.
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, and 16: mITT Population [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 activities). Higher score indicated severe condition.
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 [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=higher pain/difficulty).
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 [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).
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 [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.
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 [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.
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: ITT Population [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 the 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. Participants with specified reduction (as percent) from baseline at Week 8 are reported.
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: mITT Population [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.
Number of Participants With Improvement of At Least (>=) 2 Points From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16: ITT Population [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 activities). Higher score indicated severe condition.
Number of Participants With Improvement of At Least (>=) 2 Points From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 12 and 16: mITT Population [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 activities). Higher score indicated severe condition.
Change From Baseline in Average Pain Score in the Index Knee or Index Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16: ITT Population [Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16]
Participants assessed daily average pain in the index joint (knee/hip) during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain). Higher score indicated greater pain. The baseline mean was calculated using the daily pain scores in the index joint (knee/hip) over the 3 days in the initial pain assessment period and the weekly mean was calculated using the daily pain scores in the index joint (knee/hip) within each assessment week.
Change From Baseline in Average Pain Score in the Index Knee or Index Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16: mITT Population [Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16]
Participants assessed daily average pain in the index joint (knee/hip) during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain). Higher score indicated greater pain. The baseline mean was calculated using the daily pain scores in the index joint (knee/hip) over the 3 days in the initial pain assessment period and the weekly mean was calculated using the daily pain scores in the index joint (knee/hip) within each assessment week.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population [Baseline, Weeks 2, 4, 8, 12, and 16]
The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness 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 2 individual questions scored on NRS of 0 to 10; with higher scores indicating more stiffness. Total score range for WOMAC stiffness subscale score is 0 to 10, where higher scores indicate more stiffness. Stiffness is defined as a sensation of decreased ease in moving the index joint (knee/hip).
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, and 16: mITT Population [Baseline, Weeks 2, 4, 8, 12, and 16]
The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness 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 2 individual questions scored on NRS of 0 to 10; with higher scores indicating more stiffness. Total score range for WOMAC stiffness subscale score is 0 to 10, where higher scores indicate more stiffness. Stiffness is defined as a sensation of decreased ease in moving the index joint (knee/hip).
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, and 16: ITT Population [Baseline, Weeks 2, 4, 8, 12, and 16]
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain (5 items), stiffness (2 items) and physical function (17 items) in participants with OA of the index knee or index hip. WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher score indicates worse response.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, and 16: mITT Population [Baseline, Weeks 2, 4, 8, 12, and 16]
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain (5 items), stiffness (2 items) and physical function (17 items) in participants with OA of the index knee or index hip. WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher score indicates worse response.
Change From Baseline in WOMAC Pain Subscale Item (Pain When Walking on a Flat Surface) at Weeks 2, 4, 8, 12, and 16: ITT Population [Baseline, Weeks 2, 4, 8, 12, and 16]
Participants answered: "How much pain have you had when walking on a flat surface?" Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicated greater pain.
Change From Baseline in WOMAC Pain Subscale Item (Pain When Walking on a Flat Surface) at Weeks 2, 4, 8, 12, and 16: mITT Population [Baseline, Weeks 2, 4, 8, 12, and 16]
Participants answered: "How much pain have you had when walking on a flat surface?" Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicated greater pain.
Change From Baseline in WOMAC Pain Subscale Item (Pain When Going Up or Down Stairs) at Weeks 2, 4, 8, 12, and 16: ITT Population [Baseline, Weeks 2, 4, 8, 12, and 16]
Participants answered: "How much pain have you had when going up or down stairs?" Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicated greater pain.
Change From Baseline in WOMAC Pain Subscale Item (Pain When Going Up or Down Stairs) at Weeks 2, 4, 8, 12, and 16: mITT Population [Baseline, Weeks 2, 4, 8, 12, and 16]
Participants answered: "How much pain have you had when going up or down stairs?" Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicated greater pain.
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: ITT Population [Baseline, Week 12]
SF-36v2: standardized survey evaluating 8 health concepts (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health). Total score for each health concept was scaled 0-100 (100 = highest level of functioning).
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: mITT Population [Baseline, Week 12]
SF-36v2: standardized survey evaluating 8 health concepts (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health). Total score for each health concept was scaled 0-100 (100 = highest level of functioning).
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Aggregate Scores at Week 12: ITT Population [Baseline, Week 12]
SF-36v2: standardized survey evaluating 8 health concepts (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health). Total score for each health concept was scaled 0-100 (100=highest level of functioning). For obtaining physical and mental component scores, z-score for each scale = (observed score - mean score for general 1990 United States [US] population)/corresponding standard deviation. The 2 component scores were obtained by multiplying each aspect z-score by physical or mental factor score coefficient (1990 general US population) and summing the eight products. Component scores indicated how many standard deviations higher (in case of positive z-score [better functioning])/lower (in case of negative z-score [worse functioning]) participant's value was relative to the mean of the reference population. Change from baseline >0 indicates an improvement.
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Aggregate Scores at Week 12: mITT Population [Baseline, Week 12]
SF-36v2: standardized survey evaluating 8 health concepts (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health). Total score for each health concept was scaled 0-100 (100=highest level of functioning). For obtaining physical and mental component scores, z-score for each scale = (observed score - mean score for general 1990 United States [US] population)/corresponding standard deviation. The 2 component scores were obtained by multiplying each aspect z-score by physical or mental factor score coefficient (1990 general US population) and summing the eight products. Component scores indicated how many standard deviations higher (in case of positive z-score [better functioning])/lower (in case of negative z-score [worse functioning]) participant's value was relative to the mean of the reference population. Change from baseline >0 indicates an improvement.
Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Health State Profile Utility Score at Week 12: ITT Population [Baseline, Week 12]
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains/items: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each item has 3 possible responses: no problems (level 1), some problems (level 2), and extreme problems (level 3). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Health State Profile Utility Score at Week 12: mITT Population [Baseline, Week 12]
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains/items: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each item has 3 possible responses: no problems (level 1), some problems (level 2), and extreme problems (level 3). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: ITT Population [Baseline, Week 12]
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 dimensions/domains/items: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each item has 3 possible responses: no dysfunction (level 1), moderate/some dysfunction (level 2), and extreme dysfunction (level 3). Change from baseline at Week 12 is defined as: Improved (positive change), No change, and Worsened (negative change). Number of participants with response is reported.
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: mITT Population [Baseline, Week 12]
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 dimensions/domains/items: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each item has 3 possible responses: no dysfunction (level 1), moderate/some dysfunction (level 2), and extreme dysfunction (level 3). Change from baseline at Week 12 is defined as: Improved (positive change), No change, and Worsened (negative change). Number of participants with response is reported.
Number of Participants Who Discontinued From Study Due to Lack of Efficacy [Baseline up to Week 24]
Time to Discontinuation From Study Due to Lack of Efficacy [Baseline up to Week 24]
Number of Participants With Rescue Medication (RM) Usage [Weeks 2, 4, 8, 12, and 16]
In the event of inadequate pain relief for OA during the double-blind treatment period, participants were allowed to take up to 3000 mg of acetaminophen (tablet/capsule/caplets) per day up to 3 days per week as a rescue medication.
Number of Days With Rescue Medication (RM) Usage [Weeks 2, 4, 8, 12, and 16]
In the event of inadequate pain relief for OA during the double-blind treatment period, participants were allowed to take up to 3000 mg of acetaminophen (tablet/capsule/caplets) per day up to 3 days per week as a rescue medication. Results are shown in number of days of rescue medication usage per week.
Amount of Rescue Medication Used [Weeks 2, 4, 8, 12, and 16]
In the event of inadequate pain relief for OA during the double-blind treatment period, participants were allowed to take up to 3000 mg of acetaminophen (tablet/capsule/caplets) per day up to 3 days per week as a rescue medication. Results are presented as total dose of acetaminophen (in mg) per week.
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 18 [Baseline, Weeks 2, 4, 8, 12, 16, and 18]
NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness are 24 items and scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes and sensation are 13 items and scored 0 = normal, 1= decreased, or 2 = absent. Total NIS score is the sum of the left and right limb scores. Total possible NIS score range 0 to 244, higher score=greater impairment.
Number of Participants With Anti-Drug (Tanezumab) Antibody (ADA) [Baseline, Week 8 and 18]
Human serum samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA). Only participants receiving tanezumab were to be analyzed for this measure. A participant may be represented in more than 1 category.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Baseline up to 112 days after last intravenous dose]
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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 112 days after last dose 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.
Number of Participants With Pre-Specified Opioid-Related Adverse Events According to Severity [Baseline up to 112 days after last intravenous dose]
Pre-specified opioid-related adverse events: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty urinating, confusion and vomiting. Number of participants who experienced any of the pre-specified opioid-related adverse event are reported. Pre-specified opioid-related adverse events were assessed according to severity: mild (did not interfere with participant's usual function); moderate (interfered to some extent with participant's usual function); and severe (interfered significantly with participant's usual function).
Number of Participants With Adverse Event of Abnormal Peripheral Sensation According to Severity [Baseline up to 112 days after last intravenous dose]
Adverse event of abnormal peripheral sensation: allodynia, burning sensation, decreased vibratory sense, dysaesthesia, hyperaesthesia, hyperpathia, hypoaesthesia, neuralgia, neuritis, neuropathy peripheral, pallanesthesia, paraesthesia, paraesthesia oral, peripheral sensory neuropathy, polyneuropathy, sensory disturbance, sensory loss and thermohypoaesthesia. Adverse event of abnormal peripheral sensation was assessed according to severity: mild (did not interfere with participant's usual function); moderate (interfered to some extent with participant's usual function); and severe (interfered significantly with participant's usual function).
Tanezumab Plasma Concentration [Predose, 1 hour post-dose on Day 1, Week 8; Week 18]
Plasma concentration of tanezumab was measured using a validated, sensitive and specific enzyme-linked immunosorbent assay (ELISA). Only participants receiving tanezumab were to be analyzed for this measure.
Total Nerve Growth Factor (NGF) Serum Concentration [Predose, 1 hour post-dose on Day 1, Week 8; Predose: Week 18]
Serum samples were analyzed for determining total NGF concentration. Total NGF was analyzed using a validated, sensitive, and specific immune-affinity enrichment liquid chromatography tandem mass spectrometric (IA/LC/MS/MS) method.

Other Outcome Measures

Number of Participants With Intravenous (IV) Doses of Study Medication [Day 1 up to Week 16]
Number of participants are reported based on the maximum number of IV doses of either tanezumab or placebo received.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

osteoarthritis of the knee or hip according to Kellgren-Lawrence x-ray grade of 2

Exclusion Criteria:

pregnancy or intent to become pregnant
BMI greater than 39
other severe pain, significant cardiac, neurological or psychiatric disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Achieve Clinical Research	Birmingham	Alabama	United States	35209
2	Alabama Orthopaedic Clinics, PC	Mobile	Alabama	United States	36608
3	Horizon Research Group, Inc.	Mobile	Alabama	United States	36608
4	Arizona Research Center, Inc.	Phoenix	Arizona	United States	85023
5	Osteoporosis Medical Center	Beverly Hills	California	United States	90211
6	Med Frontier Clinical Research	Buena Park	California	United States	90620
7	Providence Clinical Research	Burbank	California	United States	91505
8	Valley Research	Fresno	California	United States	93720
9	Apex Research Institute	Santa Ana	California	United States	92705
10	Medvin Clinical Research	Van Nuys	California	United States	91405
11	Advanced Radiology	Stamford	Connecticut	United States	06902
12	Stamford Therapeutics Consortium	Stamford	Connecticut	United States	06905
13	Clinical Research of South Florida	Coral Gables	Florida	United States	33134
14	Homestead Clinical Research Group, P.A.	Cutler Bay	Florida	United States	33189
15	Riverside Clinical Research	Edgewater	Florida	United States	32132
16	Florida Clinical Research Center, LLC	Fruitland Park	Florida	United States	34731
17	Adult Medicine Specialists	Longwood	Florida	United States	32779
18	Genesis Research International	Longwood	Florida	United States	32779
19	Community Research Foundation, Inc.	Miami	Florida	United States	33155
20	Compass Research, LLC	Orlando	Florida	United States	32806
21	Advent Clinical Research Centers, Inc.	Pinellas Park	Florida	United States	33781
22	Dale G. Bramlet, MD	Saint Petersburg	Florida	United States	33703
23	Sarasota Center For Clinical Research	Sarasota	Florida	United States	34232
24	Palm Beach Research Center	West Palm Beach	Florida	United States	33409
25	Laureate Clinical Research Group	Atlanta	Georgia	United States	30342
26	Drug Studies America Inc.	Marietta	Georgia	United States	30060
27	North Georgia Clinical Research	Woodstock	Georgia	United States	30189
28	North Goergia Internal Medicine	Woodstock	Georgia	United States	30189
29	Americana Orthopedics	Boise	Idaho	United States	83702
30	Sonora Clinical Research, LLC.	Boise	Idaho	United States	83702
31	Northwest Indiana Center for Clinical Research	Valparaiso	Indiana	United States	46383
32	Commonwealth Biomedical Research	Madisonville	Kentucky	United States	42431
33	Mid-Atlantic Medical Research	Hollywood	Maryland	United States	20636
34	Miray Medical Center	Brockton	Massachusetts	United States	02301
35	MedVadis Research Corporation	Watertown	Massachusetts	United States	02472-3930
36	Clinical Pharmacology Study Group	Worcester	Massachusetts	United States	01610
37	Great Lakes Research Group, Incorporated	Bay City	Michigan	United States	48706
38	The Center for Clinical Trials	Biloxi	Mississippi	United States	39531
39	Mercy Health Research	Saint Louis	Missouri	United States	63141
40	Midwest Minor Medical	Omaha	Nebraska	United States	68114
41	Quality Clinical Research, Inc.	Omaha	Nebraska	United States	68114
42	Midwest Minor Medical	Omaha	Nebraska	United States	68127
43	Midwest Minor Medical	Omaha	Nebraska	United States	68144
44	Diagnostic Center of Medicine	Henderson	Nevada	United States	89052
45	Office of Matthew Barton, MD	Las Vegas	Nevada	United States	89144
46	Comprehensive Clinical Research	Berlin	New Jersey	United States	08009
47	Office of Andrew J. Porges, MD PC	Roslyn	New York	United States	11576
48	MediSpect, LLC	Boone	North Carolina	United States	28607
49	Crescent Medical Research	Salisbury	North Carolina	United States	28144
50	Hilltop Medical Research Center	Cincinnati	Ohio	United States	45224
51	Columbus Clinical Research	Columbus	Ohio	United States	43213
52	Health Research of Oklahoma	Oklahoma City	Oklahoma	United States	73103
53	Brandywine Clinical Research	Downingtown	Pennsylvania	United States	19335-2620
54	Piedmont Arthritis Clinic, PA	Greenville	South Carolina	United States	29601-3973
55	Health Concepts	Rapid City	South Dakota	United States	57702
56	TriCities Medical Research	Bristol	Tennessee	United States	37620
57	Appalachian Medical Research Inc.	Johnson City	Tennessee	United States	37604-1417
58	ClinRx Research, LLC	Carrollton	Texas	United States	75007
59	Tekton Research, Inc	Georgetown	Texas	United States	78628
60	One Step Diagnostic (X-Ray Facility)	Houston	Texas	United States	77030
61	Pioneer Research Solutions	Houston	Texas	United States	77098
62	Leander Healthcare Center	Leander	Texas	United States	78641
63	ClinRx Research	Richardson	Texas	United States	75080
64	Oakwell Clinical research, LLC	San Antonio	Texas	United States	78218
65	Grayline Clinical Drug Trials	Wichita Falls	Texas	United States	76309
66	Northwest Clinical Research Center	Bellevue	Washington	United States	98007
67	LKH/Universitatsklinikum Graz	Graz		Austria	A-8036
68	Nuhr Zentrum	Senftenberg		Austria	A-3541
69	ClinPharm International GmbH	Wien		Austria	A-1090
70	Synexus ClinPharm GmbH	Wien		Austria	A-1090
71	Rheuma Zentrum Favoriten	Wien		Austria	A-1100
72	CCBR A/S	Aalborg		Denmark	9000
73	CCBR A/S	Ballerup		Denmark	2750
74	Frederiksberg Hospital Parker Institute	Frederiksberg		Denmark	2000
75	CCBR A/S	Vejle		Denmark	7100
76	Charité Universitätsmedizin Berlin	Berlin		Germany	10117
77	Klinische Forschung Berlin-Buch GmbH	Berlin		Germany	13125
78	Viereck-Apotheke	Berlin		Germany	13125
79	Charité Campus Virchow-Klinikum Apotheke	Berlin		Germany	13353
80	ClinPharm International GmbH	Bochum		Germany	44787
81	Herz Apotheke	Bochum		Germany	44787
82	Synexus ClinPharm GmbH	Bochum		Germany	44787
83	Synexus ClinPharm GmbH / Frankfurt/M	Frankfurt am Main		Germany	60596
84	Schiller-Apotheke	Goppingen		Germany	73033
85	Schmerz und Palliativ-Zentrum Goppingen	Goppingen		Germany	73033
86	Falken Apotheke Hoheluft	Hamburg		Germany	20253
87	Klinische Forschung Hamburg GmbH	Hamburg		Germany	20253
88	Klinische Forschung Hannover-Mitte GmbH	Hannover		Germany	30159
89	Löwen Apotheke	Hannover		Germany	30159
90	Synexus ClinPharm GmbH	Leipzig		Germany	04103
91	Arkana Apotheke OHG	Leipzig		Germany	04315
92	Synexus ClinPharm GmbH Pruefzentrum Magdeburg	Magdeburg		Germany	39104
93	Apotheke im MSZ	Magdeburg		Germany	39112
94	Schwanen Apotheke am Markt	Offenbach am Main		Germany	63065
95	Klinische Forschung Schwerin GmbH	Schwerin		Germany	19055
96	Sonnenapotheke	Schwerin		Germany	19057
97	Nzoz Centrum Medyczne	Bialystok		Poland	15-337
98	Szpital Specjalistyczny im. J. Dietla	Krakow		Poland	30-119
99	NZOZ REUMED Sp.zo.o.	Lublin		Poland	20 607
100	Medyczne Centrum Hetmanska	Poznan		Poland	60-218
101	NZOZ "Nasz Lekarz"	Torun		Poland	87-100
102	Centrum Medyczne OSTEOMED NZOZ	Warszawa		Poland	02-256
103	Hospital Nuestra Senora de la Esperanza	Santiago de Compostela	A Coruña	Spain	15705
104	Complejo Hospitalario Universitario de A Coruna	A Coruna		Spain	15006
105	Hospital Regional Universitario Carlos Haya (Hospital Civil)	Malaga		Spain	29009
106	Hospital Regional Universitario Carlos Haya (Hospital Civil)	Malaga		Spain	29010
107	Hospital Universitario Virgen Macarena	Sevilla		Spain	41009
108	Me3plus AB	Goteborg		Sweden	400 14
109	Me3plus AB	Goteborg		Sweden	412 63
110	Avdelningen for klinisk provning, Sahlgrenska Universitetssjukhuset	Goteborg		Sweden	413 45
111	Center for Clinical Studies	Malmö		Sweden	211 52
112	Bragee Medect AB	Stockholm		Sweden	115 22

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:

NCT00985621

Other Study ID Numbers:

A4091030
2009-013329-41
OA OXY STUDY

First Posted:

Sep 28, 2009

Last Update Posted:

May 14, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Keywords provided by Pfizer

Additional relevant MeSH terms:

Osteoarthritis

Oxycodone

Tanezumab

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Oxycodone CR
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Period Title: Overall Study
STARTED	142	161	152	159
Treated	141	161	150	158
COMPLETED	28	30	29	22
NOT COMPLETED	114	131	123	137

Baseline Characteristics

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Oxycodone CR	Total
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.	Total of all reporting groups
Overall Participants	141	161	150	158	610
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.2 (10.5)	57.8 (9.2)	57.0 (9.8)	57.6 (9.1)	57.4 (9.6)
Sex: Female, Male (Count of Participants)
Female	92 65.2%	96 59.6%	94 62.7%	99 62.7%	381 62.5%
Male	49 34.8%	65 40.4%	56 37.3%	59 37.3%	229 37.5%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: ITT Population
Description	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.
Time Frame	Baseline, Week 8

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of randomized intravenous study medication (either tanezumab or placebo). Missing data were imputed using last observation carried forward (LOCF).

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Oxycodone CR
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Measure Participants	141	161	150	158
Baseline	7.75 (1.21)	7.85 (1.27)	7.63 (1.30)	7.85 (1.27)
Change at Week 8	-2.74 (2.26)	-3.71 (2.49)	-3.63 (2.62)	-2.71 (2.36)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg
	Comments	Analysis was performed using analysis of co-variance (ANCOVA) model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, 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	Least Squares (LS) Mean Difference
	Estimated Value	-0.96
	Confidence Interval	(2-Sided) 95% -1.49 to -0.44
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.27
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg
	Comments	Analysis was performed using analysis of co-variance (ANCOVA) model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, 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	-0.97
	Confidence Interval	(2-Sided) 95% -1.50 to -0.43
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.27
	Estimation Comments

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description
Modified intent-to-treat (mITT) analysis set included all participants in ITT analysis set who had Week 8 visit on or before 23 June 2010 (effective date of the United States Food and Drug Administration [US FDA] imposed clinical hold). Missing data were imputed using LOCF.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Oxycodone CR
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Measure Participants	137	153	149	156
Baseline	7.75 (1.20)	7.87 (1.26)	7.64 (1.31)	7.86 (1.27)
Change at Week 8	-2.58 (2.30)	-3.42 (2.64)	-3.01 (2.69)	-2.41 (2.29)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg, Oxycodone CR
	Comments	Analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, 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	-0.97
	Confidence Interval	(2-Sided) 95% -1.49 to -0.45
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.27
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg, Oxycodone CR
	Comments	Analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.018
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.63
	Confidence Interval	(2-Sided) 95% -1.16 to -0.11
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.27
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Oxycodone CR
	Comments	Analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.700
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.11
	Confidence Interval	(2-Sided) 95% -0.43 to 0.65
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.28
	Estimation Comments

3. Secondary Outcome

Title	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 12, and 16: ITT Population
Description	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.
Time Frame	Baseline, Weeks 2, 4, 12, and 16

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of randomized intravenous study medication (either tanezumab or placebo). Missing data were imputed using LOCF.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Oxycodone CR
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Measure Participants	141	161	150	158
Change at Week 2	-2.12 (1.91)	-2.47 (2.23)	-2.29 (2.25)	-2.31 (2.09)
Change at Week 4	-2.55 (2.09)	-3.56 (2.54)	-3.45 (2.62)	-2.87 (2.25)
Change at Week 12	-2.85 (2.37)	-3.82 (2.62)	-3.64 (2.60)	-2.80 (2.41)
Change at Week 16	-2.95 (2.46)	-3.80 (2.60)	-3.65 (2.51)	-2.79 (2.39)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg
	Comments	Change at Week 2: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.177
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.32
	Confidence Interval	(2-Sided) 95% -0.78 to 0.14
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.24
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg
	Comments	Change at Week 2: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.416
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.19
	Confidence Interval	(2-Sided) 95% -0.66 to 0.28
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.24
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg
	Comments	Change at Week 4: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, 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	-0.98
	Confidence Interval	(2-Sided) 95% -1.50 to -0.46
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.26
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg
	Comments	Change at Week 4: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, 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	-0.95
	Confidence Interval	(2-Sided) 95% -1.48 to -0.43
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.27
	Estimation Comments

4. Secondary Outcome

Title	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 12, and 16: mITT Population
Description	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.
Time Frame	Baseline, Weeks 2, 4, 12, and 16

Outcome Measure Data

Analysis Population Description
mITT analysis set included all participants in ITT analysis set who had Week 8 visit on or before 23 June 2010 (effective date of the US FDA imposed clinical hold). Missing data were imputed using LOCF.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Oxycodone CR
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Measure Participants	137	153	149	156
Change at Week 2	-1.98 (1.92)	-2.34 (2.25)	-2.05 (2.18)	-2.08 (2.17)
Change at Week 4	-2.37 (2.15)	-3.27 (2.58)	-2.85 (2.68)	-2.48 (2.29)
Change at Week 12	-2.69 (2.42)	-3.58 (2.76)	-3.06 (2.69)	-2.57 (2.37)
Change at Week 16	-2.85 (2.55)	-3.63 (2.77)	-3.16 (2.68)	-2.58 (2.35)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg, Oxycodone CR
	Comments	Change at Week 2: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.319
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.23
	Confidence Interval	(2-Sided) 95% -0.69 to 0.22
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.23
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg, Oxycodone CR
	Comments	Change at Week 2: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.916
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.02
	Confidence Interval	(2-Sided) 95% -0.43 to 0.48
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.23
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Oxycodone CR
	Comments	Change at Week 2: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.526
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.15
	Confidence Interval	(2-Sided) 95% -0.63 to 0.32
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.24
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg, Oxycodone CR
	Comments	Change at Week 4: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.004
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.75
	Confidence Interval	(2-Sided) 95% -1.26 to -0.24
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.26
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg, Oxycodone CR
	Comments	Change at Week 4: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.134
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.39
	Confidence Interval	(2-Sided) 95% -0.90 to 0.12
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.26
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, Oxycodone CR
	Comments	Change at Week 4: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.497
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.18
	Confidence Interval	(2-Sided) 95% -0.71 to 0.35
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.27
	Estimation Comments

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of randomized intravenous study medication (either tanezumab or placebo). Missing data were imputed using LOCF. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Oxycodone CR
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Measure Participants	140	161	150	158
Baseline	7.19 (1.50)	7.30 (1.58)	7.04 (1.54)	7.25 (1.53)
Change at Week 2	-1.51 (1.73)	-2.16 (2.30)	-1.95 (2.08)	-1.71 (1.94)
Change at Week 4	-1.89 (1.96)	-3.04 (2.59)	-2.94 (2.61)	-2.10 (2.20)
Change at Week 8	-2.01 (2.09)	-3.18 (2.49)	-3.08 (2.50)	-2.14 (2.30)
Change at Week 12	-2.17 (2.26)	-3.34 (2.62)	-3.09 (2.45)	-2.17 (2.28)
Change at Week 16	-2.26 (2.37)	-3.27 (2.61)	-3.10 (2.42)	-2.18 (2.26)

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description
mITT analysis set included all participants in ITT analysis set who had Week 8 visit on or before 23 June 2010 (effective date of the US FDA imposed clinical hold). Missing data were imputed using LOCF. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Oxycodone CR
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Measure Participants	136	153	149	156
Baseline	7.17 (1.51)	7.32 (1.59)	7.05 (1.54)	7.26 (1.53)
Change at Week 2	-1.41 (1.73)	-2.00 (2.32)	-1.73 (1.99)	-1.56 (1.94)
Change at Week 4	-1.73 (2.00)	-2.80 (2.69)	-2.47 (2.59)	-1.83 (2.16)
Change at Week 8	-1.87 (2.03)	-3.00 (2.68)	-2.62 (2.58)	-1.87 (2.24)
Change at Week 12	-2.03 (2.21)	-3.19 (2.78)	-2.65 (2.60)	-1.95 (2.24)
Change at Week 16	-2.20 (2.38)	-3.22 (2.78)	-2.77 (2.64)	-1.97 (2.21)

7. Secondary Outcome

Title	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, and 16: ITT Population
Description	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 activities). Higher score indicated severe condition.
Time Frame	Baseline, Weeks 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of randomized intravenous study medication (either tanezumab or placebo). Missing data were imputed using LOCF.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Oxycodone CR
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Measure Participants	141	161	150	158
Baseline	3.60 (0.68)	3.58 (0.65)	3.57 (0.68)	3.59 (0.62)
Change at Week 2	-0.49 (0.88)	-0.71 (0.90)	-0.63 (0.78)	-0.54 (0.76)
Change at Week 4	-0.57 (0.85)	-0.99 (0.96)	-0.99 (0.84)	-0.64 (0.78)
Change at Week 8	-0.56 (0.86)	-0.93 (0.97)	-1.01 (0.97)	-0.58 (0.78)
Change at Week 12	-0.64 (0.88)	-0.99 (0.97)	-1.07 (0.96)	-0.59 (0.86)
Change at Week 16	-0.63 (0.87)	-0.96 (0.97)	-1.07 (0.95)	-0.59 (0.83)

8. Secondary Outcome

Title	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, and 16: mITT Population
Description	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 activities). Higher score indicated severe condition.
Time Frame	Baseline, Weeks 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description
mITT analysis set included all participants in ITT analysis set who had Week 8 visit on or before 23 June 2010 (effective date of the US FDA imposed clinical hold). Missing data were imputed using LOCF.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Oxycodone CR
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Measure Participants	137	153	149	156
Baseline	3.59 (0.68)	3.59 (0.65)	3.56 (0.68)	3.59 (0.62)
Change at Week 2	-0.47 (0.88)	-0.71 (0.89)	-0.55 (0.76)	-0.49 (0.74)
Change at Week 4	-0.50 (0.86)	-0.94 (0.95)	-0.82 (0.82)	-0.54 (0.75)
Change at Week 8	-0.55 (0.91)	-0.93 (0.98)	-0.81 (0.84)	-0.52 (0.74)
Change at Week 12	-0.63 (0.93)	-0.98 (0.96)	-0.83 (0.84)	-0.56 (0.81)
Change at Week 16	-0.67 (0.94)	-0.97 (0.97)	-0.87 (0.83)	-0.55 (0.79)

9. Secondary Outcome

Title	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
Description	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=higher pain/difficulty).
Time Frame	Weeks 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of randomized intravenous study medication (either tanezumab or placebo). Missing data were imputed using LOCF.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Oxycodone CR
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Measure Participants	141	161	150	158
Week 2	70 49.6%	89 55.3%	82 54.7%	81 51.3%
Week 4	87 61.7%	117 72.7%	107 71.3%	97 61.4%
Week 8	81 57.4%	120 74.5%	105 70%	93 58.9%
Week 12	83 58.9%	120 74.5%	110 73.3%	100 63.3%
Week 16	84 59.6%	120 74.5%	112 74.7%	95 60.1%

10. Secondary Outcome

Title	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
Description	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).
Time Frame	Weeks 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description
mITT analysis set included all participants in ITT analysis set who had Week 8 visit on or before 23 June 2010 (effective date of the US FDA imposed clinical hold). Missing data were imputed using LOCF.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Oxycodone CR
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Measure Participants	137	153	149	156
Week 2	64 45.4%	79 49.1%	74 49.3%	70 44.3%
Week 4	76 53.9%	105 65.2%	87 58%	83 52.5%
Week 8	78 55.3%	108 67.1%	86 57.3%	80 50.6%
Week 12	80 56.7%	110 68.3%	89 59.3%	87 55.1%
Week 16	84 59.6%	111 68.9%	93 62%	87 55.1%

11. Secondary Outcome

Title	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
Description	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.
Time Frame	Weeks 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of randomized intravenous study medication (either tanezumab or placebo). Missing data were imputed using LOCF.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Oxycodone CR
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Measure Participants	141	161	150	158
Week 2: >=30% Reduction	59 41.8%	75 46.6%	66 44%	71 44.9%
Week 2: >=50% Reduction	30 21.3%	46 28.6%	42 28%	33 20.9%
Week 2: >=70% Reduction	10 7.1%	23 14.3%	15 10%	13 8.2%
Week 2: >=90% Reduction	1 0.7%	5 3.1%	4 2.7%	5 3.2%
Week 4: >=30% Reduction	72 51.1%	98 60.9%	97 64.7%	86 54.4%
Week 4: >=50% Reduction	44 31.2%	72 44.7%	68 45.3%	48 30.4%
Week 4: >=70% Reduction	15 10.6%	48 29.8%	47 31.3%	25 15.8%
Week 4: >=90% Reduction	3 2.1%	20 12.4%	14 9.3%	7 4.4%
Week 8: >=30% Reduction	78 55.3%	109 67.7%	99 66%	75 47.5%
Week 8: >=50% Reduction	47 33.3%	71 44.1%	73 48.7%	47 29.7%
Week 8: >=70% Reduction	21 14.9%	44 27.3%	47 31.3%	27 17.1%
Week 8: >=90% Reduction	5 3.5%	20 12.4%	16 10.7%	4 2.5%
Week 12: >=30% Reduction	80 56.7%	107 66.5%	102 68%	81 51.3%
Week 12: >=50% Reduction	44 31.2%	75 46.6%	77 51.3%	51 32.3%
Week 12: >=70% Reduction	26 18.4%	48 29.8%	44 29.3%	26 16.5%
Week 12: >=90% Reduction	6 4.3%	25 15.5%	18 12%	6 3.8%
Week 16: >=30% Reduction	78 55.3%	107 66.5%	103 68.7%	78 49.4%
Week 16: >=50% Reduction	47 33.3%	76 47.2%	75 50%	51 32.3%
Week 16: >=70% Reduction	29 20.6%	47 29.2%	43 28.7%	28 17.7%
Week 16: >=90% Reduction	8 5.7%	24 14.9%	19 12.7%	3 1.9%

12. Secondary Outcome

Title	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
Description	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.
Time Frame	Weeks 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description
mITT analysis set included all participants in ITT analysis set who had Week 8 visit on or before 23 June 2010 (effective date of the US FDA imposed clinical hold). Missing data were imputed using LOCF.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Oxycodone CR
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Measure Participants	137	153	149	156
Week 2: >=30% Reduction	54 38.3%	67 41.6%	58 38.7%	63 39.9%
Week 2: >=50% Reduction	28 19.9%	41 25.5%	37 24.7%	31 19.6%
Week 2: >=70% Reduction	9 6.4%	21 13%	12 8%	13 8.2%
Week 2: >=90% Reduction	1 0.7%	4 2.5%	2 1.3%	5 3.2%
Week 4: >=30% Reduction	62 44%	88 54.7%	78 52%	74 46.8%
Week 4: >=50% Reduction	39 27.7%	61 37.9%	55 36.7%	40 25.3%
Week 4: >=70% Reduction	13 9.2%	40 24.8%	37 24.7%	22 13.9%
Week 4: >=90% Reduction	3 2.1%	17 10.6%	9 6%	6 3.8%
Week 8: >=30% Reduction	73 51.8%	94 58.4%	81 54%	69 43.7%
Week 8: >=50% Reduction	43 30.5%	63 39.1%	57 38%	38 24.1%
Week 8: >=70% Reduction	16 11.3%	43 26.7%	39 26%	22 13.9%
Week 8: >=90% Reduction	5 3.5%	19 11.8%	8 5.3%	4 2.5%
Week 12: >=30% Reduction	76 53.9%	97 60.2%	83 55.3%	76 48.1%
Week 12: >=50% Reduction	41 29.1%	68 42.2%	61 40.7%	43 27.2%
Week 12: >=70% Reduction	21 14.9%	45 28%	38 25.3%	21 13.3%
Week 12: >=90% Reduction	6 4.3%	24 14.9%	9 6%	7 4.4%
Week 16: >=30% Reduction	78 55.3%	97 60.2%	87 58%	75 47.5%
Week 16: >=50% Reduction	44 31.2%	71 44.1%	63 42%	44 27.8%
Week 16: >=70% Reduction	25 17.7%	47 29.2%	40 26.7%	21 13.3%
Week 16: >=90% Reduction	8 5.7%	23 14.3%	10 6.7%	5 3.2%

13. Secondary Outcome

Title	Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: ITT Population
Description	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 the 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. Participants with specified reduction (as percent) from baseline at Week 8 are reported.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of randomized intravenous study medication (either tanezumab or placebo). Missing data were imputed using LOCF.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Oxycodone CR
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Measure Participants	141	161	150	158
Greater than (>) 0% Reduction	121 85.8%	149 92.5%	134 89.3%	139 88%
>=10% Reduction	109 77.3%	138 85.7%	127 84.7%	125 79.1%
>=20% Reduction	91 64.5%	125 77.6%	110 73.3%	101 63.9%
>=30% Reduction	78 55.3%	109 67.7%	99 66%	75 47.5%
>=40% Reduction	54 38.3%	93 57.8%	86 57.3%	57 36.1%
>=50% Reduction	47 33.3%	71 44.1%	73 48.7%	47 29.7%
>=60% Reduction	31 22%	62 38.5%	61 40.7%	38 24.1%
>=70% Reduction	21 14.9%	44 27.3%	47 31.3%	27 17.1%
>=80% Reduction	11 7.8%	30 18.6%	28 18.7%	10 6.3%
>=90% Reduction	5 3.5%	20 12.4%	16 10.7%	4 2.5%
100% Reduction	0 0%	12 7.5%	5 3.3%	2 1.3%

14. Secondary Outcome

Title	Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: mITT Population
Description	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.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description
mITT analysis set included all participants in ITT analysis set who had Week 8 visit on or before 23 June 2010 (effective date of the US FDA imposed clinical hold). Missing data were imputed using LOCF.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Oxycodone CR
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Measure Participants	137	153	149	156
>0% Reduction	108 76.6%	127 78.9%	115 76.7%	119 75.3%
>=10% Reduction	94 66.7%	119 73.9%	111 74%	105 66.5%
>=20% Reduction	83 58.9%	106 65.8%	92 61.3%	92 58.2%
>=30% Reduction	73 51.8%	94 58.4%	81 54%	69 43.7%
>=40% Reduction	51 36.2%	80 49.7%	67 44.7%	51 32.3%
>=50% Reduction	43 30.5%	63 39.1%	57 38%	38 24.1%
>=60% Reduction	29 20.6%	54 33.5%	47 31.3%	31 19.6%
>=70% Reduction	16 11.3%	43 26.7%	39 26%	22 13.9%
>=80% Reduction	14 9.9%	26 16.1%	22 14.7%	11 7%
>=90% Reduction	5 3.5%	19 11.8%	8 5.3%	4 2.5%
100% Reduction	1 0.7%	11 6.8%	3 2%	1 0.6%

15. Secondary Outcome

Title	Number of Participants With Improvement of At Least (>=) 2 Points From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16: ITT Population
Description	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 activities). Higher score indicated severe condition.
Time Frame	Weeks 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of randomized intravenous study medication (either tanezumab or placebo). Missing data were imputed using LOCF.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Oxycodone CR
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Measure Participants	141	161	150	158
Week 2	16 11.3%	24 14.9%	19 12.7%	17 10.8%
Week 4	17 12.1%	45 28%	37 24.7%	19 12%
Week 8	13 9.2%	36 22.4%	42 28%	17 10.8%
Week 12	17 12.1%	40 24.8%	47 31.3%	23 14.6%
Week 16	18 12.8%	38 23.6%	44 29.3%	18 11.4%

16. Secondary Outcome

Title	Number of Participants With Improvement of At Least (>=) 2 Points From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 12 and 16: mITT Population
Description	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 activities). Higher score indicated severe condition.
Time Frame	Weeks 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description
mITT analysis set included all participants in ITT analysis set who had Week 8 visit on or before 23 June 2010 (effective date of the US FDA imposed clinical hold). Missing data were imputed using LOCF.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Oxycodone CR
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Measure Participants	137	153	149	156
Week 2	15 10.6%	23 14.3%	17 11.3%	16 10.1%
Week 4	16 11.3%	39 24.2%	32 21.3%	15 9.5%
Week 8	14 9.9%	38 23.6%	31 20.7%	14 8.9%
Week 12	18 12.8%	39 24.2%	33 22%	19 12%
Week 16	21 14.9%	39 24.2%	35 23.3%	16 10.1%

17. Secondary Outcome

Title	Change From Baseline in Average Pain Score in the Index Knee or Index Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16: ITT Population
Description	Participants assessed daily average pain in the index joint (knee/hip) during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain). Higher score indicated greater pain. The baseline mean was calculated using the daily pain scores in the index joint (knee/hip) over the 3 days in the initial pain assessment period and the weekly mean was calculated using the daily pain scores in the index joint (knee/hip) within each assessment week.
Time Frame	Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of randomized intravenous study medication (either tanezumab or placebo). Missing data were imputed using LOCF. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Oxycodone CR
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Measure Participants	138	160	148	155
Baseline	7.18 (1.80)	7.28 (1.62)	6.98 (1.84)	7.03 (1.72)
Change at Week 1	-0.79 (1.30)	-1.71 (1.93)	-1.47 (1.84)	-1.15 (1.65)
Change at Week 2	-1.26 (1.63)	-1.96 (2.23)	-1.43 (2.13)	-1.54 (1.99)
Change at Week 3	-1.57 (1.73)	-2.27 (2.42)	-1.71 (2.29)	-1.67 (2.08)
Change at Week 4	-1.70 (1.81)	-2.65 (2.49)	-2.28 (2.60)	-1.76 (2.10)
Change at Week 6	-1.91 (1.95)	-2.87 (2.55)	-2.43 (2.66)	-1.94 (2.18)
Change at Week 8	-1.96 (1.99)	-2.82 (2.54)	-2.38 (2.72)	-1.83 (2.18)
Change at Week 10	-2.06 (2.16)	-2.92 (2.62)	-2.39 (2.72)	-1.89 (2.23)
Change at Week 12	-2.07 (2.27)	-2.94 (2.60)	-2.38 (2.67)	-1.88 (2.33)
Change at Week 16	-2.09 (2.31)	-2.90 (2.63)	-2.39 (2.68)	-1.86 (2.28)

18. Secondary Outcome

Title	Change From Baseline in Average Pain Score in the Index Knee or Index Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16: mITT Population
Description	Participants assessed daily average pain in the index joint (knee/hip) during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain). Higher score indicated greater pain. The baseline mean was calculated using the daily pain scores in the index joint (knee/hip) over the 3 days in the initial pain assessment period and the weekly mean was calculated using the daily pain scores in the index joint (knee/hip) within each assessment week.
Time Frame	Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16

Outcome Measure Data

Analysis Population Description
mITT analysis set included all participants in ITT analysis set who had Week 8 visit on or before 23 June 2010 (effective date of the US FDA imposed clinical hold). Missing data were imputed using LOCF. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Oxycodone CR
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Measure Participants	134	152	147	153
Baseline	7.16 (1.81)	7.31 (1.62)	6.98 (1.84)	7.05 (1.71)
Change at Week 1	-0.79 (1.24)	-1.71 (1.96)	-1.50 (1.81)	-1.16 (1.64)
Change at Week 2	-1.23 (1.59)	-1.99 (2.19)	-1.51 (2.10)	-1.46 (1.96)
Change at Week 3	-1.54 (1.74)	-2.28 (2.31)	-1.73 (2.20)	-1.58 (2.07)
Change at Week 4	-1.63 (1.85)	-2.70 (2.42)	-2.21 (2.52)	-1.70 (2.10)
Change at Week 6	-1.78 (1.96)	-2.92 (2.48)	-2.37 (2.58)	-1.85 (2.17)
Change at Week 8	-1.82 (2.00)	-2.88 (2.50)	-2.36 (2.63)	-1.78 (2.16)
Change at Week 10	-1.95 (2.17)	-2.98 (2.56)	-2.40 (2.63)	-1.83 (2.20)
Change at Week 12	-1.96 (2.27)	-3.00 (2.53)	-2.36 (2.61)	-1.83 (2.27)
Change at Week 16	-1.96 (2.31)	-2.97 (2.55)	-2.40 (2.63)	-1.84 (2.23)

19. Secondary Outcome

Title	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population
Description	The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness 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 2 individual questions scored on NRS of 0 to 10; with higher scores indicating more stiffness. Total score range for WOMAC stiffness subscale score is 0 to 10, where higher scores indicate more stiffness. Stiffness is defined as a sensation of decreased ease in moving the index joint (knee/hip).
Time Frame	Baseline, Weeks 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of randomized intravenous study medication (either tanezumab or placebo). Missing data were imputed using LOCF.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Oxycodone CR
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Measure Participants	141	161	150	158
Baseline	7.22 (1.67)	7.30 (1.92)	7.15 (1.82)	7.39 (1.72)
Change at Week 2	-1.49 (1.83)	-2.24 (2.50)	-2.19 (2.41)	-1.78 (2.16)
Change at Week 4	-1.88 (1.95)	-3.12 (2.70)	-3.08 (2.91)	-2.16 (2.35)
Change at Week 8	-1.92 (2.17)	-3.09 (2.60)	-3.28 (2.77)	-2.19 (2.43)
Change at Week 12	-2.15 (2.35)	-3.33 (2.75)	-3.31 (2.72)	-2.25 (2.45)
Change at Week 16	-2.20 (2.50)	-3.24 (2.73)	-3.25 (2.66)	-2.19 (2.40)

20. Secondary Outcome

Title	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, and 16: mITT Population
Description	The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness 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 2 individual questions scored on NRS of 0 to 10; with higher scores indicating more stiffness. Total score range for WOMAC stiffness subscale score is 0 to 10, where higher scores indicate more stiffness. Stiffness is defined as a sensation of decreased ease in moving the index joint (knee/hip).
Time Frame	Baseline, Weeks 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description
mITT analysis set included all participants in ITT analysis set who had Week 8 visit on or before 23 June 2010 (effective date of the US FDA imposed clinical hold). Missing data were imputed using LOCF.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Oxycodone CR
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Measure Participants	137	153	149	156
Baseline	7.22 (1.69)	7.29 (1.93)	7.16 (1.82)	7.39 (1.72)
Change at Week 2	-1.38 (1.87)	-2.08 (2.53)	-1.90 (2.26)	-1.57 (2.13)
Change at Week 4	-1.71 (2.02)	-2.91 (2.82)	-2.61 (2.90)	-1.92 (2.36)
Change at Week 8	-1.77 (2.14)	-2.97 (2.74)	-2.72 (2.88)	-1.92 (2.34)
Change at Week 12	-2.01 (2.32)	-3.24 (2.88)	-2.77 (2.85)	-2.06 (2.40)
Change at Week 16	-2.14 (2.47)	-3.24 (2.83)	-2.83 (2.87)	-2.06 (2.37)

21. Secondary Outcome

Title	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, and 16: ITT Population
Description	WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain (5 items), stiffness (2 items) and physical function (17 items) in participants with OA of the index knee or index hip. WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher score indicates worse response.
Time Frame	Baseline, Weeks 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of randomized intravenous study medication (either tanezumab or placebo). Missing data were imputed using LOCF.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Oxycodone CR
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Measure Participants	141	161	150	158
Baseline	7.39 (1.32)	7.48 (1.43)	7.27 (1.40)	7.50 (1.33)
Change at Week 2	-1.71 (1.67)	-2.29 (2.21)	-2.15 (2.04)	-1.94 (1.91)
Change at Week 4	-2.11 (1.88)	-3.24 (2.49)	-3.16 (2.58)	-2.38 (2.12)
Change at Week 8	-2.23 (2.05)	-3.32 (2.40)	-3.33 (2.49)	-2.35 (2.22)
Change at Week 12	-2.39 (2.20)	-3.49 (2.55)	-3.35 (2.45)	-2.41 (2.23)
Change at Week 16	-2.47 (2.33)	-3.42 (2.53)	-3.34 (2.39)	-2.39 (2.20)

22. Secondary Outcome

Title	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, and 16: mITT Population
Description	WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain (5 items), stiffness (2 items) and physical function (17 items) in participants with OA of the index knee or index hip. WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher score indicates worse response.
Time Frame	Baseline, Weeks 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description
mITT analysis set included all participants in ITT analysis set who had Week 8 visit on or before 23 June 2010 (effective date of the US FDA imposed clinical hold). Missing data were imputed using LOCF.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Oxycodone CR
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Measure Participants	137	153	149	156
Baseline	7.38 (1.34)	7.50 (1.44)	7.28 (1.40)	7.51 (1.33)
Change at Week 2	-1.60 (1.70)	-2.14 (2.25)	-1.90 (1.96)	-1.74 (1.94)
Change at Week 4	-1.94 (1.93)	-2.99 (2.61)	-2.64 (2.61)	-2.08 (2.13)
Change at Week 8	-2.08 (2.03)	-3.13 (2.59)	-2.79 (2.60)	-2.07 (2.16)
Change at Week 12	-2.25 (2.19)	-3.34 (2.72)	-2.83 (2.60)	-2.20 (2.21)
Change at Week 16	-2.40 (2.36)	-3.36 (2.71)	-2.92 (2.62)	-2.20 (2.19)

23. Secondary Outcome

Title	Change From Baseline in WOMAC Pain Subscale Item (Pain When Walking on a Flat Surface) at Weeks 2, 4, 8, 12, and 16: ITT Population
Description	Participants answered: "How much pain have you had when walking on a flat surface?" Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicated greater pain.
Time Frame	Baseline, Weeks 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of randomized intravenous study medication (either tanezumab or placebo). Missing data were imputed using LOCF.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Oxycodone CR
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Measure Participants	141	161	150	158
Baseline	7.58 (1.57)	7.80 (1.45)	7.67 (1.54)	7.70 (1.66)
Change at Week 2	-2.01 (2.17)	-2.61 (2.53)	-2.43 (2.39)	-2.27 (2.17)
Change at Week 4	-2.46 (2.30)	-3.54 (2.72)	-3.58 (2.86)	-2.91 (2.42)
Change at Week 8	-2.70 (2.63)	-3.75 (2.64)	-3.82 (2.86)	-2.72 (2.50)
Change at Week 12	-2.85 (2.72)	-3.84 (2.80)	-3.85 (2.80)	-2.80 (2.58)
Change at Week 16	-2.91 (2.73)	-3.79 (2.75)	-3.76 (2.76)	-2.72 (2.48)

24. Secondary Outcome

Title	Change From Baseline in WOMAC Pain Subscale Item (Pain When Walking on a Flat Surface) at Weeks 2, 4, 8, 12, and 16: mITT Population
Description	Participants answered: "How much pain have you had when walking on a flat surface?" Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicated greater pain.
Time Frame	Baseline, Weeks 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description
mITT analysis set included all participants in ITT analysis set who had Week 8 visit on or before 23 June 2010 (effective date of the US FDA imposed clinical hold). Missing data were imputed using LOCF.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Oxycodone CR
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Measure Participants	137	153	149	156
Baseline	7.60 (1.56)	7.80 (1.46)	7.68 (1.54)	7.72 (1.62)
Change at Week 2	-1.85 (2.15)	-2.47 (2.55)	-2.19 (2.28)	-1.99 (2.15)
Change at Week 4	-2.26 (2.34)	-3.20 (2.73)	-2.98 (2.84)	-2.50 (2.37)
Change at Week 8	-2.50 (2.59)	-3.36 (2.77)	-3.19 (2.92)	-2.39 (2.33)
Change at Week 12	-2.66 (2.75)	-3.54 (2.92)	-3.23 (2.88)	-2.56 (2.44)
Change at Week 16	-2.83 (2.81)	-3.57 (2.90)	-3.32 (2.90)	-2.51 (2.37)

25. Secondary Outcome

Title	Change From Baseline in WOMAC Pain Subscale Item (Pain When Going Up or Down Stairs) at Weeks 2, 4, 8, 12, and 16: ITT Population
Description	Participants answered: "How much pain have you had when going up or down stairs?" Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicated greater pain.
Time Frame	Baseline, Weeks 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of randomized intravenous study medication (either tanezumab or placebo). Missing data were imputed using LOCF.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Oxycodone CR
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Measure Participants	141	161	150	158
Baseline	8.59 (1.20)	8.39 (1.29)	8.45 (1.42)	8.53 (1.37)
Change at Week 2	-2.06 (1.99)	-2.34 (2.45)	-2.39 (2.40)	-2.08 (2.10)
Change at Week 4	-2.64 (2.12)	-3.39 (2.78)	-3.48 (2.84)	-2.64 (2.31)
Change at Week 8	-2.77 (2.34)	-3.58 (2.81)	-3.74 (2.86)	-2.51 (2.37)
Change at Week 12	-2.87 (2.38)	-3.70 (2.98)	-3.76 (2.87)	-2.68 (2.48)
Change at Week 16	-3.02 (2.55)	-3.61 (2.86)	-3.75 (2.80)	-2.66 (2.45)

26. Secondary Outcome

Title	Change From Baseline in WOMAC Pain Subscale Item (Pain When Going Up or Down Stairs) at Weeks 2, 4, 8, 12, and 16: mITT Population
Description	Participants answered: "How much pain have you had when going up or down stairs?" Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicated greater pain.
Time Frame	Baseline, Weeks 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description
mITT analysis set included all participants in ITT analysis set who had Week 8 visit on or before 23 June 2010 (effective date of the US FDA imposed clinical hold). Missing data were imputed using LOCF.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Oxycodone CR
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Measure Participants	137	153	149	156
Baseline	8.59 (1.20)	8.42 (1.27)	8.44 (1.42)	8.55 (1.35)
Change at Week 2	-1.90 (1.98)	-2.21 (2.45)	-2.06 (2.26)	-1.87 (2.16)
Change at Week 4	-2.44 (2.19)	-3.10 (2.82)	-2.81 (2.79)	-2.24 (2.28)
Change at Week 8	-2.62 (2.36)	-3.25 (2.86)	-3.04 (2.86)	-2.21 (2.29)
Change at Week 12	-2.71 (2.45)	-3.40 (2.99)	-3.11 (2.88)	-2.40 (2.44)
Change at Week 16	-2.91 (2.64)	-3.42 (2.92)	-3.24 (2.89)	-2.40 (2.42)

27. Secondary Outcome

Title	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: ITT Population
Description	SF-36v2: standardized survey evaluating 8 health concepts (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health). Total score for each health concept was scaled 0-100 (100 = highest level of functioning).
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of randomized intravenous study medication (either tanezumab or placebo). Missing data were imputed using baseline observation carried forward (BOCF).

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Oxycodone CR
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Measure Participants	141	161	150	158
General Health: Baseline	55.28 (22.21)	58.35 (19.26)	60.01 (21.71)	55.47 (18.53)
General Health: Change at Week 12	1.89 (10.11)	2.22 (9.37)	2.85 (10.47)	1.21 (10.66)
Physical Function: Baseline	29.09 (18.40)	31.80 (19.15)	32.14 (18.61)	28.55 (17.70)
Physical Function: Change at Week 12	6.03 (15.83)	10.88 (21.94)	5.57 (15.15)	4.05 (13.30)
Role Physical: Baseline	37.81 (22.80)	40.72 (24.20)	39.46 (21.74)	36.75 (21.53)
Role Physical: Change at Week 12	7.14 (17.54)	10.83 (22.26)	6.17 (16.53)	5.62 (18.36)
Bodily Pain: Baseline	28.43 (13.80)	28.80 (14.51)	29.08 (15.48)	27.23 (14.15)
Bodily Pain: Change at Week 12	6.38 (15.63)	12.38 (21.23)	8.32 (16.82)	6.36 (13.92)
Vitality: Baseline	46.37 (20.06)	48.95 (20.59)	47.25 (21.03)	45.33 (20.61)
Vitality: Change at Week 12	3.10 (10.58)	4.19 (12.99)	3.08 (12.33)	2.25 (13.99)
Social Function: Baseline	57.36 (26.18)	62.34 (27.42)	61.58 (26.63)	57.91 (25.84)
Social Function: Change at Week 12	5.41 (15.69)	5.28 (16.40)	4.50 (17.46)	4.11 (17.07)
Role Emotional: Baseline	60.22 (31.11)	64.70 (31.38)	63.89 (30.48)	60.81 (30.92)
Role Emotional: Change at Week 12	3.72 (16.01)	4.92 (19.58)	2.06 (19.09)	0.42 (15.19)
Mental Health: Baseline	68.40 (20.39)	69.13 (19.60)	68.27 (20.37)	67.59 (19.26)
Mental Health: Change at Week 12	1.03 (9.77)	1.37 (10.61)	2.20 (10.61)	0.70 (12.00)

28. Secondary Outcome

Title	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: mITT Population
Description	SF-36v2: standardized survey evaluating 8 health concepts (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health). Total score for each health concept was scaled 0-100 (100 = highest level of functioning).
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description
mITT analysis set included all participants in ITT analysis set who had Week 8 visit on or before 23 June 2010 (effective date of the US FDA imposed clinical hold). Missing data were imputed using BOCF.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Oxycodone CR
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Measure Participants	137	153	149	156
General Health: Baseline	55.61 (22.01)	59.08 (18.43)	60.21 (21.64)	55.56 (18.60)
General Health: Change at Week 12	1.85 (9.14)	1.39 (8.49)	2.61 (9.00)	0.74 (8.71)
Physical Function: Baseline	29.18 (18.62)	31.54 (19.35)	32.29 (18.59)	28.50 (17.75)
Physical Function: Change at Week 12	5.36 (15.35)	8.84 (19.48)	3.76 (13.07)	2.82 (11.81)
Role Physical: Baseline	37.73 (23.09)	41.30 (24.44)	39.43 (21.81)	36.66 (21.07)
Role Physical: Change at Week 12	6.07 (16.27)	9.60 (20.20)	5.49 (15.56)	4.21 (15.61)
Bodily Pain: Baseline	28.55 (13.96)	29.06 (14.52)	29.21 (15.45)	27.18 (14.06)
Bodily Pain: Change at Week 12	5.54 (14.93)	10.53 (20.14)	7.41 (16.12)	5.14 (12.93)
Vitality: Baseline	46.30 (20.23)	48.73 (20.58)	47.32 (21.09)	45.11 (20.54)
Vitality: Change at Week 12	2.97 (10.14)	4.33 (12.61)	3.02 (11.22)	1.64 (12.40)
Social Function: Baseline	57.39 (26.15)	62.58 (27.64)	61.66 (26.70)	57.93 (25.76)
Social Function: Change at Week 12	4.65 (15.08)	5.07 (15.47)	5.12 (16.38)	3.29 (15.43)
Role Emotional: Baseline	60.04 (31.35)	64.54 (31.10)	63.93 (30.58)	60.68 (30.92)
Role Emotional: Change at Week 12	3.89 (14.92)	4.52 (19.19)	2.07 (17.00)	-0.11 (11.86)
Mental Health: Baseline	68.03 (20.53)	69.22 (19.57)	68.36 (20.41)	67.53 (19.36)
Mental Health: Change at Week 12	0.62 (9.44)	1.70 (9.82)	2.55 (9.09)	0.48 (10.06)

29. Secondary Outcome

Title	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Aggregate Scores at Week 12: ITT Population
Description	SF-36v2: standardized survey evaluating 8 health concepts (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health). Total score for each health concept was scaled 0-100 (100=highest level of functioning). For obtaining physical and mental component scores, z-score for each scale = (observed score - mean score for general 1990 United States [US] population)/corresponding standard deviation. The 2 component scores were obtained by multiplying each aspect z-score by physical or mental factor score coefficient (1990 general US population) and summing the eight products. Component scores indicated how many standard deviations higher (in case of positive z-score [better functioning])/lower (in case of negative z-score [worse functioning]) participant's value was relative to the mean of the reference population. Change from baseline >0 indicates an improvement.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of randomized intravenous study medication (either tanezumab or placebo). Missing data were imputed using BOCF.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Oxycodone CR
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Measure Participants	141	161	150	158
Mental Component Aggregate: Baseline	-0.28 (1.27)	-0.13 (1.27)	-0.20 (1.28)	-0.28 (1.27)
Mental Component Aggregate: Change at Week 12	0.08 (0.53)	0.04 (0.65)	0.07 (0.72)	0.01 (0.67)
Physical Component Aggregate: Baseline	-1.99 (0.72)	-1.91 (0.64)	-1.88 (0.69)	-2.03 (0.64)
Physical Component Aggregate: Change at Week 12	0.26 (0.63)	0.47 (0.88)	0.28 (0.57)	0.23 (0.57)

30. Secondary Outcome

Title	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Aggregate Scores at Week 12: mITT Population
Description	SF-36v2: standardized survey evaluating 8 health concepts (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health). Total score for each health concept was scaled 0-100 (100=highest level of functioning). For obtaining physical and mental component scores, z-score for each scale = (observed score - mean score for general 1990 United States [US] population)/corresponding standard deviation. The 2 component scores were obtained by multiplying each aspect z-score by physical or mental factor score coefficient (1990 general US population) and summing the eight products. Component scores indicated how many standard deviations higher (in case of positive z-score [better functioning])/lower (in case of negative z-score [worse functioning]) participant's value was relative to the mean of the reference population. Change from baseline >0 indicates an improvement.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description
mITT analysis set included all participants in ITT analysis set who had Week 8 visit on or before 23 June 2010 (effective date of the US FDA imposed clinical hold). Missing data were imputed using BOCF.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Oxycodone CR
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Measure Participants	137	153	149	156
Mental Component Aggregate: Baseline	-0.30 (1.27)	-0.13 (1.26)	-0.19 (1.28)	-0.29 (1.27)
Mental Component Aggregate: Change at Week 12	0.08 (0.51)	0.07 (0.61)	0.11 (0.64)	-0.00 (0.56)
Physical Component Aggregate: Baseline	-1.98 (0.72)	-1.90 (0.65)	-1.88 (0.69)	-2.03 (0.63)
Physical Component Aggregate: Change at Week 12	0.23 (0.60)	0.38 (0.78)	0.22 (0.53)	0.18 (0.51)

31. Secondary Outcome

Title	Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Health State Profile Utility Score at Week 12: ITT Population
Description	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains/items: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each item has 3 possible responses: no problems (level 1), some problems (level 2), and extreme problems (level 3). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description
ITT analysis set. Here 'overall number of participants analyzed' signifies participants who were evaluable for this measure and 'number analyzed' signifies participants who were evaluable at specified time-point for each treatment arm, respectively.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Oxycodone CR
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Measure Participants	140	161	150	156
Baseline	0.39 (0.31)	0.41 (0.31)	0.43 (0.29)	0.38 (0.30)
Change at Week 12	0.25 (0.36)	0.33 (0.34)	0.22 (0.31)	0.14 (0.28)

32. Secondary Outcome

Title	Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Health State Profile Utility Score at Week 12: mITT Population
Description	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains/items: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each item has 3 possible responses: no problems (level 1), some problems (level 2), and extreme problems (level 3). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description
mITT analysis set. Here 'overall number of participants analyzed' signifies participants who were evaluable for this measure and 'number analyzed' signifies participants who were evaluable at specified time-point for each treatment arm, respectively.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Oxycodone CR
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Measure Participants	136	153	149	154
Baseline	0.40 (0.31)	0.41 (0.31)	0.43 (0.30)	0.38 (0.30)
Change at Week 12	0.25 (0.36)	0.33 (0.34)	0.22 (0.31)	0.14 (0.28)

33. Secondary Outcome

Title	Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: ITT Population
Description	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 dimensions/domains/items: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each item has 3 possible responses: no dysfunction (level 1), moderate/some dysfunction (level 2), and extreme dysfunction (level 3). Change from baseline at Week 12 is defined as: Improved (positive change), No change, and Worsened (negative change). Number of participants with response is reported.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description
ITT analysis set. Here 'overall number of participants analyzed' signifies participants who were evaluable for this measure and 'number analyzed' signifies participants who were evaluable at specified time-point for each treatment arm, respectively.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Oxycodone CR
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Measure Participants	140	161	150	156
Mobility, Baseline: Level 1	8 5.7%	15 9.3%	10 6.7%	7 4.4%
Mobility, Baseline: Level 2	132 93.6%	146 90.7%	140 93.3%	148 93.7%
Mobility, Baseline: Level 3	0 0%	0 0%	0 0%	1 0.6%
Mobility, Change at Wk 12: Improved	12 8.5%	29 18%	17 11.3%	4 2.5%
Mobility, Change at Wk 12: No Change	43 30.5%	31 19.3%	39 26%	53 33.5%
Mobility, Change at Wk 12: Worsened	1 0.7%	1 0.6%	1 0.7%	2 1.3%
Self-care, Baseline: Level 1	93 66%	122 75.8%	99 66%	108 68.4%
Self-care, Baseline: Level 2	45 31.9%	38 23.6%	50 33.3%	48 30.4%
Self-care, Baseline: Level 3	2 1.4%	1 0.6%	1 0.7%	0 0%
Self-care, Change at Week 12: Improved	15 10.6%	12 7.5%	17 11.3%	10 6.3%
Self-care, Change at Week 12: No Change	39 27.7%	46 28.6%	38 25.3%	44 27.8%
Self-care, Change at Week 12: Worsened	2 1.4%	3 1.9%	2 1.3%	5 3.2%
Usual Activities, Baseline: Level 1	15 10.6%	21 13%	19 12.7%	15 9.5%
Usual Activities, Baseline: Level 2	123 87.2%	134 83.2%	125 83.3%	136 86.1%
Usual Activities, Baseline: Level 3	2 1.4%	6 3.7%	6 4%	5 3.2%
Usual Activities, Change at Week 12: Improved	15 10.6%	27 16.8%	15 10%	21 13.3%
Usual Activities, Change at Week 12: No Change	36 25.5%	32 19.9%	41 27.3%	36 22.8%
Usual Activities, Change at Week 12: Worsened	5 3.5%	2 1.2%	1 0.7%	2 1.3%
Pain and Discomfort, Baseline: Level 1	2 1.4%	1 0.6%	0 0%	1 0.6%
Pain and Discomfort, Baseline: Level 2	77 54.6%	92 57.1%	94 62.7%	83 52.5%
Pain and Discomfort, Baseline: Level 3	60 42.6%	68 42.2%	55 36.7%	72 45.6%
Pain and Discomfort, Change at Week 12: Improved	23 16.3%	32 19.9%	21 14%	17 10.8%
Pain and Discomfort, Change at Week 12: No Change	29 20.6%	28 17.4%	35 23.3%	39 24.7%
Pain and Discomfort, Change at Week 12: Worsened	3 2.1%	1 0.6%	1 0.7%	3 1.9%
Anxiety and Depression, Baseline: Level 1	79 56%	86 53.4%	92 61.3%	84 53.2%
Anxiety and Depression, Baseline: Level 2	52 36.9%	68 42.2%	52 34.7%	68 43%
Anxiety and Depression, Baseline: Level 3	9 6.4%	7 4.3%	5 3.3%	4 2.5%
Anxiety and Depression, Change at Week 12: Improved	16 11.3%	16 9.9%	12 8%	9 5.7%
Anxiety and Depression, Change at Week 12: No Change	35 24.8%	40 24.8%	37 24.7%	42 26.6%
Anxiety and Depression, Change at Week 12: Worsened	5 3.5%	5 3.1%	8 5.3%	8 5.1%

34. Secondary Outcome

Title	Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: mITT Population
Description	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 dimensions/domains/items: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each item has 3 possible responses: no dysfunction (level 1), moderate/some dysfunction (level 2), and extreme dysfunction (level 3). Change from baseline at Week 12 is defined as: Improved (positive change), No change, and Worsened (negative change). Number of participants with response is reported.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description
mITT analysis set. Here 'overall number of participants analyzed' signifies participants who were evaluable for this measure and 'number anlayzed' signifies participants who were evaluable at specified time-point for each treatment arm, respectively.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Oxycodone CR
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Measure Participants	136	153	149	154
Mobility, Baseline: Level 1	8 5.7%	14 8.7%	10 6.7%	7 4.4%
Mobility, Baseline: Level 2	128 90.8%	139 86.3%	139 92.7%	146 92.4%
Mobility, Baseline: Level 3	0 0%	0 0%	0 0%	1 0.6%
Mobility, Change at Week 12: Improved	12 8.5%	29 18%	17 11.3%	4 2.5%
Mobility, Change at Week 12: No Change	43 30.5%	31 19.3%	39 26%	53 33.5%
Mobility, Change at Week 12: Worsened	1 0.7%	1 0.6%	1 0.7%	2 1.3%
SC, Baseline: Level 1	91 64.5%	118 73.3%	99 66%	108 68.4%
Self-care, Baseline: Level 2	43 30.5%	34 21.1%	49 32.7%	46 29.1%
Self-care, Baseline: Level 3	2 1.4%	1 0.6%	1 0.7%	0 0%
Self-care, Change at Week 12: Improved	15 10.6%	12 7.5%	17 11.3%	10 6.3%
Self-care, Change at Week 12: No Change	39 27.7%	46 28.6%	38 25.3%	44 27.8%
Self-care, Change at Week 12: Worsened	2 1.4%	3 1.9%	2 1.3%	5 3.2%
Usual Activities, Baseline: Level 1	15 10.6%	20 12.4%	19 12.7%	15 9.5%
Usual Activities, Baseline: Level 2	119 84.4%	128 79.5%	124 82.7%	134 84.8%
Usual Activities, Baseline: Level 3	2 1.4%	5 3.1%	6 4%	5 3.2%
Usual Activities, Change at Week 12: Improved	15 10.6%	27 16.8%	15 10%	21 13.3%
Usual Activities, Change at Week 12: No Change	36 25.5%	32 19.9%	41 27.3%	36 22.8%
Usual Activities, Change at Week 12: Worsened	5 3.5%	2 1.2%	1 0.7%	2 1.3%
Pain and Discomfort, Baseline: Level 1	2 1.4%	1 0.6%	0 0%	1 0.6%
Pain and Discomfort, Baseline: Level 2	77 54.6%	87 54%	93 62%	82 51.9%
Pain and Discomfort, Baseline: Level 3	56 39.7%	65 40.4%	55 36.7%	71 44.9%
Pain and Discomfort, Change at Week 12: Improved	23 16.3%	32 19.9%	21 14%	17 10.8%
Pain and Discomfort, Change at Week 12: No Change	29 20.6%	28 17.4%	35 23.3%	39 24.7%
Pain and Discomfort, Change at Week 12: Worsened	3 2.1%	1 0.6%	1 0.7%	3 1.9%
Anxiety and Depression, Baseline: Level 1	76 53.9%	82 50.9%	92 61.3%	83 52.5%
Anxiety and Depression, Baseline: Level 2	51 36.2%	64 39.8%	51 34%	67 42.4%
Anxiety and Depression, Baseline: Level 3	9 6.4%	7 4.3%	5 3.3%	4 2.5%
Anxiety and Depression, Change at Week 12: Improved	16 11.3%	16 9.9%	12 8%	9 5.7%
Anxiety and Depression, Change at Week 12: No Change	35 24.8%	40 24.8%	37 24.7%	42 26.6%
Anxiety and Depression, Change at Week 12: Worsened	5 3.5%	5 3.1%	8 5.3%	8 5.1%

35. Secondary Outcome

Title	Number of Participants Who Discontinued From Study Due to Lack of Efficacy
Description
Time Frame	Baseline up to Week 24

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of randomized intravenous study medication (either tanezumab or placebo).

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Oxycodone CR
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Measure Participants	141	161	150	158
Count of Participants [Participants]	10 7.1%	6 3.7%	5 3.3%	12 7.6%

36. Secondary Outcome

Title	Time to Discontinuation From Study Due to Lack of Efficacy
Description
Time Frame	Baseline up to Week 24

Outcome Measure Data

Analysis Population Description
Analysis set included participants from ITT analysis set who discontinued study due to lack of efficacy.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Oxycodone CR
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Measure Participants	10	6	5	12
Median (Full Range) [days]	29.0	43.0	56.0	30.0

37. Secondary Outcome

Title	Number of Participants With Rescue Medication (RM) Usage
Description	In the event of inadequate pain relief for OA during the double-blind treatment period, participants were allowed to take up to 3000 mg of acetaminophen (tablet/capsule/caplets) per day up to 3 days per week as a rescue medication.
Time Frame	Weeks 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of randomized intravenous study medication (either tanezumab or placebo). Missing data were imputed using LOCF.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Oxycodone CR
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Measure Participants	141	161	150	158
Week 2	90 63.8%	85 52.8%	99 66%	90 57%
Week 4	76 53.9%	65 40.4%	79 52.7%	85 53.8%
Week 8	67 47.5%	63 39.1%	65 43.3%	77 48.7%
Week 12	68 48.2%	52 32.3%	61 40.7%	78 49.4%
Week 16	68 48.2%	50 31.1%	59 39.3%	72 45.6%

38. Secondary Outcome

Title	Number of Days With Rescue Medication (RM) Usage
Description	In the event of inadequate pain relief for OA during the double-blind treatment period, participants were allowed to take up to 3000 mg of acetaminophen (tablet/capsule/caplets) per day up to 3 days per week as a rescue medication. Results are shown in number of days of rescue medication usage per week.
Time Frame	Weeks 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description
ITT analysis set. Missing data were imputed using LOCF. Here 'overall number of participants analyzed' signifies participants who were evaluable for this measure and 'number analyzed' signifies participants who were evaluable at specified time-point for each treatment arm, respectively.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Oxycodone CR
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Measure Participants	132	147	144	151
Week 2	2.72 (2.66)	2.03 (2.46)	2.58 (2.58)	2.35 (2.69)
Week 4	2.40 (2.72)	1.60 (2.43)	1.95 (2.51)	2.27 (2.68)
Week 8	2.11 (2.65)	1.33 (2.24)	1.72 (2.52)	1.75 (2.38)
Week 12	1.82 (2.39)	1.20 (2.24)	1.63 (2.41)	1.74 (2.37)
Week 16	1.73 (2.30)	1.02 (1.99)	1.40 (2.25)	1.67 (2.39)

39. Secondary Outcome

Title	Amount of Rescue Medication Used
Description	In the event of inadequate pain relief for OA during the double-blind treatment period, participants were allowed to take up to 3000 mg of acetaminophen (tablet/capsule/caplets) per day up to 3 days per week as a rescue medication. Results are presented as total dose of acetaminophen (in mg) per week.
Time Frame	Weeks 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description
ITT analysis set. Missing data were imputed using LOCF. Here 'overall number of participants analyzed' signifies participants who were evaluable for this measure and 'number analyzed' signifies participants who were evaluable at specified time-point for each treatment arm, respectively.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Oxycodone CR
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Measure Participants	132	147	144	151
Week 2	4109.38 (5190.82)	2684.03 (4193.21)	3510.56 (4321.51)	3553.33 (5395.79)
Week 4	3293.89 (4412.77)	2136.99 (3741.44)	2614.58 (4221.46)	3373.33 (4886.01)
Week 8	3000.00 (4277.85)	1659.86 (3092.18)	2336.81 (4033.87)	2539.74 (4653.86)
Week 12	2561.07 (3651.14)	1394.56 (2893.80)	2333.33 (4189.56)	2360.93 (3786.45)
Week 16	2412.88 (3416.67)	1159.86 (2619.07)	1965.28 (3865.60)	2420.53 (4121.12)

40. Secondary Outcome

Title	Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 18
Description	NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness are 24 items and scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes and sensation are 13 items and scored 0 = normal, 1= decreased, or 2 = absent. Total NIS score is the sum of the left and right limb scores. Total possible NIS score range 0 to 244, higher score=greater impairment.
Time Frame	Baseline, Weeks 2, 4, 8, 12, 16, and 18

Outcome Measure Data

Analysis Population Description
ITT analysis set. Missing data were imputed using LOCF. Here 'number analyzed' signifies participants who were evaluable at specified time-point for each treatment arm, respectively.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Oxycodone CR
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Measure Participants	141	161	150	158
Baseline	1.43 (4.93)	1.01 (3.11)	1.32 (5.83)	1.73 (4.10)
Change at Week 2	-0.42 (3.04)	-0.22 (1.40)	-0.13 (0.79)	-0.16 (1.09)
Change at Week 4	-0.09 (1.45)	-0.33 (2.00)	-0.28 (1.68)	-0.31 (1.59)
Change at Week 8	-0.18 (1.93)	-0.22 (2.07)	-0.22 (1.51)	-0.39 (2.32)
Change at Week 12	-0.19 (1.29)	-0.13 (4.13)	-0.33 (1.81)	-0.33 (1.79)
Change at Week 16	-0.40 (1.94)	-0.14 (3.78)	-0.28 (1.74)	-0.53 (2.38)
Change at Week 18	-0.25 (1.25)	-0.02 (2.91)	-0.25 (1.64)	-0.18 (2.13)

41. Secondary Outcome

Title	Number of Participants With Anti-Drug (Tanezumab) Antibody (ADA)
Description	Human serum samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA). Only participants receiving tanezumab were to be analyzed for this measure. A participant may be represented in more than 1 category.
Time Frame	Baseline, Week 8 and 18

Outcome Measure Data

Analysis Population Description
ITT analysis set. Here 'overall number of participants analyzed' signifies participants who were evaluable for this measure and 'number analyzed' signifies participants who were evaluable at specified time-point for each treatment arm, respectively.

Arm/Group Title	Tanezumab 5 mg	Tanezumab 10 mg
Arm/Group Description	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.
Measure Participants	156	144
Baseline	0 0%	1 0.6%
Week 8	1 0.7%	2 1.2%
Week 18	0 0%	0 0%

42. Secondary Outcome

Title	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description	An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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 112 days after last dose 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 112 days after last intravenous dose

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of randomized intravenous study medication (either tanezumab or placebo).

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Oxycodone CR
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Measure Participants	141	161	150	158
AEs	50 35.5%	72 44.7%	61 40.7%	100 63.3%
SAEs	2 1.4%	4 2.5%	3 2%	4 2.5%

43. Secondary Outcome

Title	Number of Participants With Pre-Specified Opioid-Related Adverse Events According to Severity
Description	Pre-specified opioid-related adverse events: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty urinating, confusion and vomiting. Number of participants who experienced any of the pre-specified opioid-related adverse event are reported. Pre-specified opioid-related adverse events were assessed according to severity: mild (did not interfere with participant's usual function); moderate (interfered to some extent with participant's usual function); and severe (interfered significantly with participant's usual function).
Time Frame	Baseline up to 112 days after last intravenous dose

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of randomized intravenous study medication (either tanezumab or placebo).

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Oxycodone CR
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Measure Participants	141	161	150	158
Fatigue: Mild	0 0%	2 1.2%	1 0.7%	6 3.8%
Fatigue: Moderate	1 0.7%	0 0%	0 0%	1 0.6%
Nausea: Mild	0 0%	5 3.1%	3 2%	14 8.9%
Nausea: Moderate	0 0%	1 0.6%	0 0%	11 7%
Dizziness: Mild	2 1.4%	2 1.2%	3 2%	10 6.3%
Constipation: Mild	1 0.7%	1 0.6%	1 0.7%	16 10.1%
Constipation: Moderate	1 0.7%	1 0.6%	0 0%	8 5.1%
Vomiting: Mild	1 0.7%	0 0%	0 0%	10 6.3%
Vomiting: Moderate	0 0%	1 0.6%	0 0%	5 3.2%

44. Secondary Outcome

Title	Number of Participants With Adverse Event of Abnormal Peripheral Sensation According to Severity
Description	Adverse event of abnormal peripheral sensation: allodynia, burning sensation, decreased vibratory sense, dysaesthesia, hyperaesthesia, hyperpathia, hypoaesthesia, neuralgia, neuritis, neuropathy peripheral, pallanesthesia, paraesthesia, paraesthesia oral, peripheral sensory neuropathy, polyneuropathy, sensory disturbance, sensory loss and thermohypoaesthesia. Adverse event of abnormal peripheral sensation was assessed according to severity: mild (did not interfere with participant's usual function); moderate (interfered to some extent with participant's usual function); and severe (interfered significantly with participant's usual function).
Time Frame	Baseline up to 112 days after last intravenous dose

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of randomized intravenous study medication (either tanezumab or placebo).

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Oxycodone CR
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Measure Participants	141	161	150	158
Burning Sensation: Mild	0 0%	0 0%	1 0.7%	0 0%
Decreased Vibratory Sense: Mild	0 0%	1 0.6%	2 1.3%	0 0%
Dysaesthesia: Mild	1 0.7%	0 0%	0 0%	1 0.6%
Hyperaesthesia: Mild	0 0%	0 0%	2 1.3%	0 0%
Hyperaesthesia: Moderate	0 0%	1 0.6%	0 0%	0 0%
Hypoaesthesia: Mild	0 0%	1 0.6%	3 2%	2 1.3%
Hypoaesthesia: Moderate	0 0%	2 1.2%	0 0%	0 0%
Hypoaesthesia: Severe	0 0%	1 0.6%	0 0%	0 0%
Neuropathy peripheral: Moderate	0 0%	1 0.6%	0 0%	0 0%
Paraesthesia: Mild	0 0%	4 2.5%	3 2%	1 0.6%
Paraesthesia: Moderate	1 0.7%	2 1.2%	0 0%	0 0%

45. Secondary Outcome

Title	Tanezumab Plasma Concentration
Description	Plasma concentration of tanezumab was measured using a validated, sensitive and specific enzyme-linked immunosorbent assay (ELISA). Only participants receiving tanezumab were to be analyzed for this measure.
Time Frame	Predose, 1 hour post-dose on Day 1, Week 8; Week 18

Outcome Measure Data

Analysis Population Description
ITT analysis set. Here 'overall number of participants analyzed' signifies participants who were evaluable for this measure and 'number analyzed' signifies participants who were evaluable at specified time-point for each treatment arm, respectively.

Arm/Group Title	Tanezumab 5 mg	Tanezumab 10 mg
Arm/Group Description	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.
Measure Participants	157	145
Predose, Day 1	36.96 (160.10)	124.1 (601.80)
1 hour post-dose, Day 1	4192 (11266)	5690 (10616)
Predose, Week 8	207.0 (288.96)	402.6 (257.29)
1 hour post-dose, Week 8	2259 (2349.1)	3583 (1754.7)
Week 18	87.05 (135.30)	240.2 (386.98)

46. Secondary Outcome

Title	Total Nerve Growth Factor (NGF) Serum Concentration
Description	Serum samples were analyzed for determining total NGF concentration. Total NGF was analyzed using a validated, sensitive, and specific immune-affinity enrichment liquid chromatography tandem mass spectrometric (IA/LC/MS/MS) method.
Time Frame	Predose, 1 hour post-dose on Day 1, Week 8; Predose: Week 18

Outcome Measure Data

Analysis Population Description
ITT analysis set. Here 'overall number of participants analyzed' signifies participants who were evaluable for this measure and 'number analyzed' signifies participants who were evaluable at specified time-point for each treatment arm, respectively.

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Oxycodone CR
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Measure Participants	116	128	124	119
Predose, Day 1	58.1 (205.1)	89.3 (538.1)	138.2 (770.7)	38.5 (10.8)
1 hour post-dose, Day 1	55.8 (172.9)	133.9 (483.5)	163.8 (565.2)	39.0 (16.7)
Predose, Week 8	92.6 (384.2)	2152.2 (1040.8)	3160.6 (1183.4)	45.5 (13.2)
1 hour post-dose, Week 8	39.8 (9.9)	2181.2 (1070.5)	3026.0 (976.1)	44.0 (22.0)
Predose, Week 18	41.0 (15.2)	1437.1 (1296.0)	2365.4 (1402.4)	48.7 (25.3)

47. Other Pre-specified Outcome

Title	Number of Participants With Intravenous (IV) Doses of Study Medication
Description	Number of participants are reported based on the maximum number of IV doses of either tanezumab or placebo received.
Time Frame	Day 1 up to Week 16

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of randomized intravenous study medication (either tanezumab or placebo).

Arm/Group Title	Placebo	Tanezumab 5 mg	Tanezumab 10 mg	Oxycodone CR
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Measure Participants	141	161	150	158
Number of IV Doses: 1	79 56%	89 55.3%	85 56.7%	97 61.4%
Number of IV Doses: 2	62 44%	72 44.7%	65 43.3%	61 38.6%

Adverse Events

	Placebo		Tanezumab 5 mg		Tanezumab 10 mg		Oxycodone CR
Time Frame
Adverse Event Reporting Description	Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.

Arm/Group Title	Placebo		Tanezumab 5 mg		Tanezumab 10 mg		Oxycodone CR
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.		Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.		Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.		Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Tanezumab 5 mg		Tanezumab 10 mg		Oxycodone CR
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/141 (1.4%)		4/161 (2.5%)		3/150 (2%)		4/158 (2.5%)
Gastrointestinal disorders
Colitis	0/141 (0%)		0/161 (0%)		0/150 (0%)		1/158 (0.6%)
General disorders
Chest pain	0/141 (0%)		1/161 (0.6%)		0/150 (0%)		0/158 (0%)
Drug ineffective	1/141 (0.7%)		0/161 (0%)		0/150 (0%)		0/158 (0%)
Hepatobiliary disorders
Cholestasis	0/141 (0%)		0/161 (0%)		1/150 (0.7%)		0/158 (0%)
Infections and infestations
Clostridial infection	1/141 (0.7%)		0/161 (0%)		0/150 (0%)		0/158 (0%)
Pneumonia primary atypical	0/141 (0%)		1/161 (0.6%)		0/150 (0%)		0/158 (0%)
Injury, poisoning and procedural complications
Clavicle fracture	0/141 (0%)		1/161 (0.6%)		0/150 (0%)		0/158 (0%)
Drug exposure during pregnancy	1/141 (0.7%)		0/161 (0%)		0/150 (0%)		0/158 (0%)
Fractured coccyx	0/141 (0%)		1/161 (0.6%)		0/150 (0%)		0/158 (0%)
Hand fracture	0/141 (0%)		1/161 (0.6%)		0/150 (0%)		0/158 (0%)
Head injury	0/141 (0%)		0/161 (0%)		0/150 (0%)		1/158 (0.6%)
Limb injury	0/141 (0%)		0/161 (0%)		0/150 (0%)		1/158 (0.6%)
Lumbar vertebral fracture	0/141 (0%)		1/161 (0.6%)		0/150 (0%)		0/158 (0%)
Road traffic accident	0/141 (0%)		1/161 (0.6%)		0/150 (0%)		0/158 (0%)
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion	0/141 (0%)		0/161 (0%)		0/150 (0%)		1/158 (0.6%)
Osteoarthritis	0/141 (0%)		0/161 (0%)		0/150 (0%)		1/158 (0.6%)
Osteonecrosis	0/141 (0%)		0/161 (0%)		2/150 (1.3%)		0/158 (0%)
Nervous system disorders
Cervical myelopathy	0/141 (0%)		1/161 (0.6%)		0/150 (0%)		0/158 (0%)
Guillain-Barre syndrome	0/141 (0%)		1/161 (0.6%)		0/150 (0%)		0/158 (0%)
Pregnancy, puerperium and perinatal conditions
Unintended pregnancy	1/141 (0.7%)		0/161 (0%)		0/150 (0%)		0/158 (0%)
Psychiatric disorders
Suicide attempt	0/141 (0%)		0/161 (0%)		0/150 (0%)		1/158 (0.6%)
Other (Not Including Serious) Adverse Events
	Placebo		Tanezumab 5 mg		Tanezumab 10 mg		Oxycodone CR
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	36/141 (25.5%)		43/161 (26.7%)		33/150 (22%)		82/158 (51.9%)
Gastrointestinal disorders
Constipation	2/141 (1.4%)		2/161 (1.2%)		1/150 (0.7%)		24/158 (15.2%)
Diarrhoea	2/141 (1.4%)		2/161 (1.2%)		3/150 (2%)		1/158 (0.6%)
Nausea	0/141 (0%)		6/161 (3.7%)		3/150 (2%)		25/158 (15.8%)
Vomiting	1/141 (0.7%)		1/161 (0.6%)		0/150 (0%)		15/158 (9.5%)
General disorders
Fatigue	1/141 (0.7%)		2/161 (1.2%)		1/150 (0.7%)		7/158 (4.4%)
Oedema peripheral	3/141 (2.1%)		4/161 (2.5%)		4/150 (2.7%)		3/158 (1.9%)
Infections and infestations
Bronchitis	1/141 (0.7%)		4/161 (2.5%)		1/150 (0.7%)		2/158 (1.3%)
Nasopharyngitis	6/141 (4.3%)		3/161 (1.9%)		4/150 (2.7%)		3/158 (1.9%)
Urinary tract infection	4/141 (2.8%)		4/161 (2.5%)		2/150 (1.3%)		4/158 (2.5%)
Injury, poisoning and procedural complications
Fall	3/141 (2.1%)		4/161 (2.5%)		1/150 (0.7%)		1/158 (0.6%)
Musculoskeletal and connective tissue disorders
Arthralgia	4/141 (2.8%)		3/161 (1.9%)		8/150 (5.3%)		2/158 (1.3%)
Back pain	2/141 (1.4%)		1/161 (0.6%)		3/150 (2%)		3/158 (1.9%)
Joint swelling	1/141 (0.7%)		1/161 (0.6%)		3/150 (2%)		0/158 (0%)
Musculoskeletal pain	2/141 (1.4%)		3/161 (1.9%)		4/150 (2.7%)		3/158 (1.9%)
Pain in extremity	2/141 (1.4%)		3/161 (1.9%)		4/150 (2.7%)		3/158 (1.9%)
Nervous system disorders
Dizziness	2/141 (1.4%)		2/161 (1.2%)		3/150 (2%)		10/158 (6.3%)
Headache	7/141 (5%)		5/161 (3.1%)		5/150 (3.3%)		8/158 (5.1%)
Hypoaesthesia	0/141 (0%)		4/161 (2.5%)		3/150 (2%)		2/158 (1.3%)
Paraesthesia	1/141 (0.7%)		6/161 (3.7%)		3/150 (2%)		1/158 (0.6%)
Somnolence	0/141 (0%)		0/161 (0%)		0/150 (0%)		7/158 (4.4%)
Psychiatric disorders
Insomnia	1/141 (0.7%)		0/161 (0%)		2/150 (1.3%)		4/158 (2.5%)
Skin and subcutaneous tissue disorders
Pruritus	1/141 (0.7%)		2/161 (1.2%)		0/150 (0%)		10/158 (6.3%)
Vascular disorders
Hypertension	2/141 (1.4%)		2/161 (1.2%)		1/150 (0.7%)		5/158 (3.2%)

Limitations/Caveats

Due to the US FDA imposed clinical hold (effective 23 June 2010), study was terminated early and planned sample size was not reached. The primary time-point was changed from Week 16 to Week 8, as per change in planned analysis.

More Information

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:

NCT00985621

Other Study ID Numbers:

A4091030
2009-013329-41
OA OXY STUDY

First Posted:

Sep 28, 2009

Last Update Posted:

May 14, 2021

Last Verified:

Apr 1, 2021