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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02528188




Registration number
NCT02528188
Ethics application status
Date submitted
19/07/2015
Date registered
19/08/2015

Titles & IDs
Public title
Long Term Safety and Efficacy Study of Tanezumab in Subjects With Osteoarthritis of the Hip or Knee
Scientific title
A PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED, MULTICENTER STUDY OF THE LONG-TERM SAFETY AND EFFICACY OF SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB IN SUBJECTS WITH OSTEOARTHRITIS OF THE HIP OR KNEE
Secondary ID [1] 0 0
2012-003721-22
Secondary ID [2] 0 0
A4091058
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Pain 0 0
Osteoarthritis, Hip 0 0
Osteoarthritis, Knee 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Neurological 0 0 0 0
Other neurological disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - NSAID
Treatment: Other - Tanezumab 2.5 mg
Treatment: Other - Tanezumab 5 mg

Active comparator: NSAID - Subcutaneous injection of placebo for tanezumab every 8 weeks plus oral NSAID (naproxen 500 mg, celecoxib 100 mg or diclofenac 75 mg) twice daily for 56 weeks

Experimental: Tanezumab 2.5 mg - Subcutaneous injection of tanezumab 2.5 mg every 8 weeks plus oral placebo for NSAID (naproxen, celecoxib or diclofenac ER) twice daily for 56 weeks

Experimental: Tanezumab 5 mg - Subcutaneous injection of tanezumab 5 mg every 8 weeks plus oral placebo for NSAID (naproxen, celecoxib or diclofenac) twice daily for 56 weeks


Treatment: Drugs: NSAID
Orally administered NSAID (naproxen 500 mg, celecoxib 100 mg or diclofenac 75 mg) twice daily for 56 weeks

Treatment: Other: Tanezumab 2.5 mg
Subcutaneous injection of tanezumab 2.5 mg every 8 weeks for 56 weeks

Treatment: Other: Tanezumab 5 mg
Subcutaneous injection of tanezumab 5 mg every 8 weeks for 56 weeks
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Adjudicated Primary Composite Joint Safety Outcome
Timepoint [1] 0 0
Baseline up to Week 80
Primary outcome [2] 0 0
Observation Time-Adjusted Event Rate of Participants With Adjudicated Primary Composite Joint Safety Outcome
Timepoint [2] 0 0
Baseline up to Week 80
Primary outcome [3] 0 0
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16
Timepoint [3] 0 0
Baseline, Week 16
Primary outcome [4] 0 0
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16
Timepoint [4] 0 0
Baseline, Week 16
Primary outcome [5] 0 0
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 16
Timepoint [5] 0 0
Baseline, Week 16
Secondary outcome [1] 0 0
Percentage of Participants With Adjudicated Secondary Composite Joint Safety Outcome
Timepoint [1] 0 0
Baseline up to Week 80
Secondary outcome [2] 0 0
Observation Time-Adjusted Event Rate of Participants With Adjudicated Secondary Composite Joint Safety Outcome
Timepoint [2] 0 0
Baseline up to Week 80
Secondary outcome [3] 0 0
Percentage of Participants With Individual Adjudicated Joint Safety Outcome
Timepoint [3] 0 0
Baseline up to Week 80
Secondary outcome [4] 0 0
Observation Time-Adjusted Event Rate of Participants With Individual Adjudicated Joint Safety Outcome
Timepoint [4] 0 0
Baseline up to Week 80
Secondary outcome [5] 0 0
Percentage of Participants With Total Joint Replacement or Adjudicated Primary Composite Joint Safety Outcome
Timepoint [5] 0 0
Baseline up to Week 80
Secondary outcome [6] 0 0
Observation Time-Adjusted Event Rate of Participants With Total Joint Replacement or Adjudicated Primary Composite Joint Safety Outcome
Timepoint [6] 0 0
Baseline up to Week 80
Secondary outcome [7] 0 0
Change From Baseline in Medial or Lateral Joint Space Width of the Index Knee (Kellgren-Lawrence Grade 2 or 3) at Weeks 56 and 80
Timepoint [7] 0 0
Baseline, Weeks 56 and 80
Secondary outcome [8] 0 0
Change From Baseline in Joint Space Width of the Index Hip (Kellgren-Lawrence Grade 2 or 3) at Weeks 56 and 80
Timepoint [8] 0 0
Baseline, Weeks 56 and 80
Secondary outcome [9] 0 0
Number of Participants With Progression of Osteoarthritis in the Index Knee (Kellgren-Lawrence Grade 2 or 3) According to Bland and Altman Method at Weeks 56 and 80
Timepoint [9] 0 0
Weeks 56 and 80
Secondary outcome [10] 0 0
Number of Participants With Progression of Osteoarthritis in the Index Hip (Kellgren-Lawrence Grade 2 or 3) According to Bland and Altman Method at Weeks 56 and 80
Timepoint [10] 0 0
Weeks 56 and 80
Secondary outcome [11] 0 0
Change From Baseline in WOMAC Pain Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56
Timepoint [11] 0 0
Baseline, Weeks 2, 4, 8, 24, 32, 40, 48 and 56
Secondary outcome [12] 0 0
Change From Baseline in WOMAC Pain Subscale at Week 64
Timepoint [12] 0 0
Baseline, Week 64
Secondary outcome [13] 0 0
Change From Baseline in WOMAC Physical Function Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56
Timepoint [13] 0 0
Baseline, Weeks 2, 4, 8, 24, 32, 40, 48 and 56
Secondary outcome [14] 0 0
Change From Baseline in WOMAC Physical Function Subscale at Week 64
Timepoint [14] 0 0
Baseline, Week 64
Secondary outcome [15] 0 0
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 24, 32, 40, 48 and 56
Timepoint [15] 0 0
Baseline, Weeks 2, 4, 8, 24, 32, 40, 48 and 56
Secondary outcome [16] 0 0
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 64
Timepoint [16] 0 0
Baseline, Week 64
Secondary outcome [17] 0 0
Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64
Timepoint [17] 0 0
Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64
Secondary outcome [18] 0 0
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64
Timepoint [18] 0 0
Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64
Secondary outcome [19] 0 0
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56
Timepoint [19] 0 0
Baseline, Weeks 16, 24 and 56
Secondary outcome [20] 0 0
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64
Timepoint [20] 0 0
Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64
Secondary outcome [21] 0 0
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56
Timepoint [21] 0 0
Baseline, Weeks 16, 24 and 56
Secondary outcome [22] 0 0
Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64
Timepoint [22] 0 0
Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64
Secondary outcome [23] 0 0
Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56
Timepoint [23] 0 0
Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56
Secondary outcome [24] 0 0
Change From Baseline in Average Pain Score in the Index Joint at Week 64
Timepoint [24] 0 0
Baseline, Week 64
Secondary outcome [25] 0 0
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Timepoint [25] 0 0
Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Secondary outcome [26] 0 0
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 64
Timepoint [26] 0 0
Baseline, Week 64
Secondary outcome [27] 0 0
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Timepoint [27] 0 0
Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Secondary outcome [28] 0 0
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 64
Timepoint [28] 0 0
Baseline, Week 64
Secondary outcome [29] 0 0
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Timepoint [29] 0 0
Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Secondary outcome [30] 0 0
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Week 64
Timepoint [30] 0 0
Baseline, Week 64
Secondary outcome [31] 0 0
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Timepoint [31] 0 0
Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Secondary outcome [32] 0 0
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Week 64
Timepoint [32] 0 0
Baseline, Week 64
Secondary outcome [33] 0 0
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56
Timepoint [33] 0 0
Weeks 16, 24 and 56
Secondary outcome [34] 0 0
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 64
Timepoint [34] 0 0
Baseline, Week 64
Secondary outcome [35] 0 0
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain
Timepoint [35] 0 0
Baseline, Weeks 8, 16, 24, 40, 56 and 64
Secondary outcome [36] 0 0
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain
Timepoint [36] 0 0
Baseline, Weeks 8, 16, 24, 40, 56 and 64
Secondary outcome [37] 0 0
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain
Timepoint [37] 0 0
Baseline, Weeks 8, 16, 24, 40, 56 and 64
Secondary outcome [38] 0 0
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain
Timepoint [38] 0 0
Baseline, Weeks 8, 16, 24, 40, 56 and 64
Secondary outcome [39] 0 0
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain
Timepoint [39] 0 0
Baseline, Weeks 8, 16, 24, 40, 56 and 64
Secondary outcome [40] 0 0
European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value
Timepoint [40] 0 0
Baseline, Weeks 8, 16, 24, 40, 56 and 64
Secondary outcome [41] 0 0
Treatment Satisfaction Questionnaire Medicine Version II (TSQM v.II) Score With Effectiveness, Side Effects, Convenience, and Overall Satisfaction Responses
Timepoint [41] 0 0
Weeks 16 and 56
Secondary outcome [42] 0 0
Patient-Reported Treatment Impact Assessment- Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving for Osteoarthritis Pain Before Enrolling?
Timepoint [42] 0 0
Weeks 16 and 56
Secondary outcome [43] 0 0
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- Overall, do You Prefer the Drug That You Received in This Study to Previous Treatment?
Timepoint [43] 0 0
Weeks 16 and 56
Secondary outcome [44] 0 0
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Willingness to Use Drug Again Assessment- Willing to Use the Same Drug That You Have Received in This Study for Your Osteoarthritis Pain?
Timepoint [44] 0 0
Weeks 16 and 56
Secondary outcome [45] 0 0
Number of Participants Who Withdrew Due to Lack of Efficacy
Timepoint [45] 0 0
Baseline up to Week 56
Secondary outcome [46] 0 0
Time to Discontinuation Due to Lack of Efficacy
Timepoint [46] 0 0
Baseline up to Week 56
Secondary outcome [47] 0 0
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Timepoint [47] 0 0
Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Secondary outcome [48] 0 0
Number of Participants Who Took Rescue Medication During Week 64
Timepoint [48] 0 0
Week 64
Secondary outcome [49] 0 0
Number of Days of Rescue Medication Used During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Timepoint [49] 0 0
Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Secondary outcome [50] 0 0
Number of Days of Rescue Medication Used During Week 64
Timepoint [50] 0 0
Week 64
Secondary outcome [51] 0 0
Amount of Rescue Medication Used During Weeks 2, 4, 8 and 16
Timepoint [51] 0 0
Weeks 2, 4, 8 and 16
Secondary outcome [52] 0 0
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis
Timepoint [52] 0 0
Baseline, Weeks 64 and 80
Secondary outcome [53] 0 0
Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Osteoarthritis
Timepoint [53] 0 0
Baseline, Weeks 64 and 80
Secondary outcome [54] 0 0
Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Osteoarthritis
Timepoint [54] 0 0
Baseline, Weeks 64 and 80
Secondary outcome [55] 0 0
Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis
Timepoint [55] 0 0
Baseline, Weeks 64 and 80
Secondary outcome [56] 0 0
Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Osteoarthritis
Timepoint [56] 0 0
Baseline, Weeks 64 and 80
Secondary outcome [57] 0 0
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis
Timepoint [57] 0 0
Baseline, Weeks 64 and 80
Secondary outcome [58] 0 0
Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis
Timepoint [58] 0 0
Baseline, Weeks 64 and 80
Secondary outcome [59] 0 0
Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis
Timepoint [59] 0 0
Baseline, Weeks 64 and 80
Secondary outcome [60] 0 0
Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80
Timepoint [60] 0 0
Baseline, Weeks 4, 8, 16, 24, 56 and 80
Secondary outcome [61] 0 0
Change From Baseline in Average Daily Minutes of Physical Activity at Weeks 16 and 56
Timepoint [61] 0 0
Baseline, Weeks 16 and 56
Secondary outcome [62] 0 0
Change From Baseline in Average Daily Physical Activity Counts at Weeks 16 and 56
Timepoint [62] 0 0
Baseline, Weeks 16 and 56
Secondary outcome [63] 0 0
Change From Baseline in Average Daily Minutes of Moderate to Vigorous Physical Activity at Weeks 16 and 56
Timepoint [63] 0 0
Baseline, Weeks 16 and 56
Secondary outcome [64] 0 0
Change From Baseline in Average Daily Minutes of Bouted (Sustained) Moderate to Vigorous Physical Activity at Weeks 16 and 56
Timepoint [64] 0 0
Baseline, Weeks 16 and 56
Secondary outcome [65] 0 0
Change From Baseline in Average Daily Step Count at Weeks 16 and 56
Timepoint [65] 0 0
Baseline, Weeks 16 and 56
Secondary outcome [66] 0 0
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [66] 0 0
Baseline up to Week 80
Secondary outcome [67] 0 0
Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [67] 0 0
Baseline up to Week 80
Secondary outcome [68] 0 0
Number of Participants With Laboratory Test Abnormalities With Regard to Normal Baseline
Timepoint [68] 0 0
Baseline up to Week 80
Secondary outcome [69] 0 0
Number of Participants With Laboratory Test Abnormalities With Regard to Abnormal Baseline
Timepoint [69] 0 0
Baseline up to Week 80
Secondary outcome [70] 0 0
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Timepoint [70] 0 0
Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Secondary outcome [71] 0 0
Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Timepoint [71] 0 0
Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Secondary outcome [72] 0 0
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80
Timepoint [72] 0 0
Baseline, Weeks 56 and 80
Secondary outcome [73] 0 0
Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 56 and 80
Timepoint [73] 0 0
Baseline, Weeks 56 and 80
Secondary outcome [74] 0 0
Number of Participants With Confirmed Orthostatic Hypotension
Timepoint [74] 0 0
Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Secondary outcome [75] 0 0
Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80
Timepoint [75] 0 0
Baseline, Weeks 24, 56 and 80
Secondary outcome [76] 0 0
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Timepoint [76] 0 0
Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Secondary outcome [77] 0 0
Number of Participants With Anti-Tanezumab Antibodies
Timepoint [77] 0 0
Baseline, Weeks 8, 16, 32, 48, 56, 64 and 80

Eligibility
Key inclusion criteria
* A diagnosis of osteoarthritis of the index hip or knee based on American College of Rheumatology criteria with Kellgren Lawrence X ray Grade of 2 as diagnosed by the Central Reader
* Currently receiving a stable dose regimen of oral NSAID (naproxen, celecoxib, diclofenac, aceclofenac, loxoprofen, ibuprofen, meloxicam, nabumetone, sulindac or ketoprofen) as described in the protocol along with a history of insufficient pain relief from, inability to tolerate or contraindication to taking acetaminophen and, tramadol or opioid treatments. Subjects must also maintain a stabilized, protocol specified NSAID dose regimen for at least the final 2 or 3 weeks of the Screening period
* WOMAC Pain subscale score of at least 5 in the index knee or hip at Screening
* Be willing to discontinue all non study pain medications for osteoarthritis and not use prohibited pain medications throughout the duration of the study
* Female subjects of childbearing potential must agree to comply with protocol specified contraceptive requirements
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subjects exceeding protocol defined BMI or body weight limits
* History of other diseases specified in the protocol (eg, inflammatory joint diseases, crystalline diseases such as gout or pseudogout) that may involve the index joint and that could interfere with efficacy assessments
* Radiographic evidence of protocol specified bone or joint conditions in any screening radiograph as determined by the central radiology reviewer
* A history of osteonecrosis or osteoporotic fracture
* History of significant trauma or surgery to a knee, hip or shoulder within the previous year
* Planned surgical procedure during the duration of the study
* Presence of conditions (eg, fibromyaliga, radiculopathy) associated with moderate to severe pain that may confound assessments or self evaluation of osteoarthritis pain
* Signs or symptoms of carpal tunnel syndrome in the year prior to Screening
* Considered unfit for surgery based upon American Society of Anesthesiologists physical classification system for surgery grading, or subjects who would not be willing to undergo joint replacement surgery if required
* Contraindications to magnetic resonance imaging
* History of intolerance or hypersensitivity to the oral NSAID (naproxen, celecoxib or diclofenac) the subject could be randomized to receive or any of its excipients or existence of a medical condition or use of concomitant medication for which the use of this NSAID is contraindicated
* History of intolerance or hypersensitivity to acetaminophen or any of its excipients or existence of a medical condition or use of concomitant medication for which the use of acetaminophen is contraindicated
* Use of prohibited medications without the appropriate washout period prior to Screening or Initial Pain Assessment Period
* History of cancer within 5 years of Screening, except for cutaneous basal cell or squamous cell cancer resolved by excision
* Subjects with signs and symptoms of clinically significant cardiac disease as described in the protocol
* Diagnosis of a transient ischemic attack in the 6 months prior to Screening, diagnosis of stroke with residual deficits that would preclude completion of required study activities
* History, diagnosis, or signs and symptoms of clinically significant neurological disease such as but not limited to peripheral or autonomic neuropathy
* History, diagnosis, signs or symptoms of any clinically significant psychiatric disorder
* History of known alcohol, analgesic or drug abuse within 2 years of Screening
* Previous exposure to exogenous NGF or to an anti-NGF antibody
* History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG fusion protein
* Poorly controlled hypertension as defined in the protocol or taking an antihypertensive that has not been stable for at least 1 month prior to Screening
* Evidence of protocol defined orthostatic hypotension at Screening
* Disqualifying score on the Survey of Autonomic Symptoms questionnaire at Screening
* Screening AST, ALT, serum creatinine or HbA1c values that exceed protocol defined limits
* Presence of drugs of abuse in screening urine toxicology panel
* Positive hepatitis B, hepatitis C or HIV test results indicative of current infection
* Participation in other investigational drug studies within protocol defined time limits
* Pregnant, breastfeeding or female subjects of childbearing potential who are unwilling or unable to follow protocol required contraceptive requirements
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the judgment of the investigator, would make the subject inappropriate for entry into this study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/07/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/02/2019
Sample size
Target
Accrual to date
Final
3021
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Genesis Research Services - Broadmeadow
Recruitment hospital [2] 0 0
Hunter Imaging Group - Cardiff
Recruitment hospital [3] 0 0
Optimus Clinical Research Pty Ltd - Kogarah
Recruitment hospital [4] 0 0
Southern Radiology - Miranda
Recruitment hospital [5] 0 0
Royal Hospital for Women - Randwick
Recruitment hospital [6] 0 0
Castlereagh Imaging - St Leonards
Recruitment hospital [7] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [8] 0 0
Australian Clinical Research Network - Sydney
Recruitment hospital [9] 0 0
Spectrum Medical Imaging - Sydney
Recruitment hospital [10] 0 0
AusTrials Pty Ltd - Sherwood
Recruitment hospital [11] 0 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment hospital [12] 0 0
Royal Adelaide Hospital Pharmacy - Adelaide
Recruitment hospital [13] 0 0
Bensons Radiology - North Adelaide
Recruitment hospital [14] 0 0
Emeritus Research - Camberwell
Recruitment hospital [15] 0 0
Capital Radiology-Malvern - Melbourne
Recruitment hospital [16] 0 0
Capital Radiology-Clayton - Melbourne
Recruitment hospital [17] 0 0
SKG Radiology Hollywood - Nedlands
Recruitment hospital [18] 0 0
RK Will Pty Ltd - Victoria Park
Recruitment postcode(s) [1] 0 0
2292 - Broadmeadow
Recruitment postcode(s) [2] 0 0
2285 - Cardiff
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
2228 - Miranda
Recruitment postcode(s) [5] 0 0
2031 - Randwick
Recruitment postcode(s) [6] 0 0
2065 - St Leonards
Recruitment postcode(s) [7] 0 0
2035 - Sydney
Recruitment postcode(s) [8] 0 0
4075 - Sherwood
Recruitment postcode(s) [9] 0 0
5000 - Adelaide
Recruitment postcode(s) [10] 0 0
5006 - North Adelaide
Recruitment postcode(s) [11] 0 0
3124 - Camberwell
Recruitment postcode(s) [12] 0 0
3144 - Melbourne
Recruitment postcode(s) [13] 0 0
3168 - Melbourne
Recruitment postcode(s) [14] 0 0
6009 - Nedlands
Recruitment postcode(s) [15] 0 0
6100 - Victoria Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Delaware
Country [8] 0 0
United States of America
State/province [8] 0 0
Florida
Country [9] 0 0
United States of America
State/province [9] 0 0
Georgia
Country [10] 0 0
United States of America
State/province [10] 0 0
Hawaii
Country [11] 0 0
United States of America
State/province [11] 0 0
Idaho
Country [12] 0 0
United States of America
State/province [12] 0 0
Illinois
Country [13] 0 0
United States of America
State/province [13] 0 0
Indiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Kansas
Country [15] 0 0
United States of America
State/province [15] 0 0
Kentucky
Country [16] 0 0
United States of America
State/province [16] 0 0
Louisiana
Country [17] 0 0
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Zaporizhzhya

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02528188