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Tanezumab In Osteoarthritis Of The Hip Or Knee

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00985621
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : September 28, 2009
Results First Posted : May 14, 2021
Last Update Posted : May 14, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : October 30, 2009
Actual Primary Completion Date : December 13, 2010
Actual Study Completion Date : February 4, 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Oxycodone

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




Primary Outcome Measures :
  1. Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: ITT Population [ Time Frame: 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.

  2. Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: Modified Intent-to-Treat (mITT) Population [ Time Frame: 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 :
  1. Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 12, and 16: ITT Population [ Time Frame: 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.

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

  3. 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 [ Time Frame: 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.

  4. 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 [ Time Frame: 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.

  5. Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, and 16: ITT Population [ Time Frame: 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.

  6. Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, and 16: mITT Population [ Time Frame: 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.

  7. 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 [ Time Frame: 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).

  8. 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 [ Time Frame: 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).

  9. 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 [ Time Frame: 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.

  10. 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 [ Time Frame: 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.

  11. 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 [ Time Frame: 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.

  12. 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 [ Time Frame: 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.

  13. 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 [ Time Frame: 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.

  14. 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 [ Time Frame: 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.

  15. 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 [ Time Frame: 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.

  16. 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 [ Time Frame: 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.

  17. 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 [ Time Frame: 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).

  18. 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 [ Time Frame: 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).

  19. Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, and 16: ITT Population [ Time Frame: 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.

  20. Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, and 16: mITT Population [ Time Frame: 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.

  21. 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 [ Time Frame: 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.

  22. 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 [ Time Frame: 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.

  23. 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 [ Time Frame: 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.

  24. 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 [ Time Frame: 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.

  25. Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: ITT Population [ Time Frame: 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).

  26. Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: mITT Population [ Time Frame: 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).

  27. 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 [ Time Frame: 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.

  28. 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 [ Time Frame: 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.

  29. Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Health State Profile Utility Score at Week 12: ITT Population [ Time Frame: 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.

  30. Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Health State Profile Utility Score at Week 12: mITT Population [ Time Frame: 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.

  31. Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: ITT Population [ Time Frame: 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.

  32. Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: mITT Population [ Time Frame: 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.

  33. Number of Participants Who Discontinued From Study Due to Lack of Efficacy [ Time Frame: Baseline up to Week 24 ]
  34. Time to Discontinuation From Study Due to Lack of Efficacy [ Time Frame: Baseline up to Week 24 ]
  35. Number of Participants With Rescue Medication (RM) Usage [ Time Frame: 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.

  36. Number of Days With Rescue Medication (RM) Usage [ Time Frame: 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.

  37. Amount of Rescue Medication Used [ Time Frame: 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.

  38. Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 18 [ Time Frame: 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.

  39. Number of Participants With Anti-Drug (Tanezumab) Antibody (ADA) [ Time Frame: 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.

  40. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 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.

  41. Number of Participants With Pre-Specified Opioid-Related Adverse Events According to Severity [ Time Frame: 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).

  42. Number of Participants With Adverse Event of Abnormal Peripheral Sensation According to Severity [ Time Frame: 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).

  43. Tanezumab Plasma Concentration [ Time Frame: 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.

  44. Total Nerve Growth Factor (NGF) Serum Concentration [ Time Frame: 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:
  1. Number of Participants With Intravenous (IV) Doses of Study Medication [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00985621


Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00985621    
Other Study ID Numbers: A4091030
2009-013329-41 ( EudraCT Number )
OA OXY STUDY ( Other Identifier: Alias Study Number )
First Posted: September 28, 2009    Key Record Dates
Results First Posted: May 14, 2021
Last Update Posted: May 14, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Keywords provided by Pfizer:
monoclonal antibody
RN624
PF-04383119
nerve growth factor
OA
pain
arthritis
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Oxycodone
Tanezumab
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents