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Tanezumab in Osteoarthritis of the Hip or Knee (2)

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: NCT00863304
Recruitment Status : Completed
First Posted : March 17, 2009
Results First Posted : May 17, 2021
Last Update Posted : May 17, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Osteoarthritis
Interventions Biological: tanezumab 10 mg
Biological: tanezumab 5 mg
Drug: naproxen
Other: placebo
Enrollment 849
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Tanezumab 5 mg + Placebo Tanezumab 10 mg + Placebo Naproxen + Placebo
Hide Arm/Group Description Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12. Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12. Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12. Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
Period Title: Overall Study
Started 212 212 213 212
Treated 209 211 209 211
Completed 18 27 26 21
Not Completed 194 185 187 191
Reason Not Completed
Adverse Event             10             4             14             16
Lost to Follow-up             1             5             4             2
Lack of Efficacy             57             26             30             28
Withdrawal by Subject             19             14             20             18
Other             1             0             0             1
Protocol Violation             2             6             2             0
Randomized, but not Treated             3             1             4             1
Entered extension study             101             129             113             125
Arm/Group Title Placebo Tanezumab 5 mg + Placebo Tanezumab 10 mg + Placebo Naproxen + Placebo Total
Hide Arm/Group Description Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12. Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12. Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12. Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8. Total of all reporting groups
Overall Number of Baseline Participants 209 211 209 211 840
Hide Baseline Analysis Population Description
Intent to treat (ITT) analysis set included all randomized participants who received at least 1 dose of randomized IV study medication (either tanezumab or placebo IV).
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 209 participants 211 participants 209 participants 211 participants 840 participants
18 to 44 years
6
   2.9%
13
   6.2%
14
   6.7%
14
   6.6%
47
   5.6%
45 to 64 years
133
  63.6%
133
  63.0%
134
  64.1%
126
  59.7%
526
  62.6%
Greater than or equal to (>=) 65 years
70
  33.5%
65
  30.8%
61
  29.2%
71
  33.6%
267
  31.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 209 participants 211 participants 209 participants 211 participants 840 participants
Female
136
  65.1%
134
  63.5%
128
  61.2%
136
  64.5%
534
  63.6%
Male
73
  34.9%
77
  36.5%
81
  38.8%
75
  35.5%
306
  36.4%
1.Primary Outcome
Title Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF)
Hide Description WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). BOCF method was used to impute missing values. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Placebo Tanezumab 5 mg + Placebo Tanezumab 10 mg + Placebo Naproxen + Placebo
Hide Arm/Group Description:
Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.
Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.
Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.
Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
Overall Number of Participants Analyzed 209 211 208 207
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 7.41  (1.38) 7.27  (1.38) 7.37  (1.39) 7.30  (1.41)
Change at week 16 -2.14  (2.74) -3.32  (2.77) -3.03  (3.05) -2.61  (2.70)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg + Placebo
Comments Analysis of Covariance (ANCOVA) was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square (LS) Mean Difference
Estimated Value -1.13
Confidence Interval (2-Sided) 95%
-1.65 to -0.62
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.26
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg + Placebo
Comments ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.80
Confidence Interval (2-Sided) 95%
-1.32 to -0.29
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.26
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Naproxen + Placebo
Comments ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.090
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.45
Confidence Interval (2-Sided) 95%
-0.96 to 0.07
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.26
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg + Placebo, Naproxen + Placebo
Comments ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.69
Confidence Interval (2-Sided) 95%
-1.21 to -0.17
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.26
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg + Placebo, Naproxen + Placebo
Comments ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.175
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.36
Confidence Interval (2-Sided) 95%
-0.87 to 0.16
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.26
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16: Baseline Observation Carried Forward (BOCF)
Hide Description WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). BOCF method was used to impute missing values. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Placebo Tanezumab 5 mg + Placebo Tanezumab 10 mg + Placebo Naproxen + Placebo
Hide Arm/Group Description:
Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.
Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.
Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.
Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
Overall Number of Participants Analyzed 209 211 208 207
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 7.04  (1.49) 6.83  (1.56) 7.09  (1.52) 6.95  (1.64)
Change at Week 16 -1.75  (2.53) -3.01  (2.64) -2.86  (2.98) -2.25  (2.51)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg + Placebo
Comments ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.23
Confidence Interval (2-Sided) 95%
-1.71 to -0.75
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.25
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg + Placebo
Comments ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.99
Confidence Interval (2-Sided) 95%
-1.48 to -0.51
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.25
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Naproxen + Placebo
Comments ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.067
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.46
Confidence Interval (2-Sided) 95%
-0.94 to 0.03
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.25
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg + Placebo, Naproxen + Placebo
Comments ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.77
Confidence Interval (2-Sided) 95%
-1.26 to -0.29
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.25
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg + Placebo, Naproxen + Placebo
Comments ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.031
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.54
Confidence Interval (2-Sided) 95%
-1.03 to -0.05
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.25
Estimation Comments [Not Specified]
3.Primary Outcome
Title Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF)
Hide Description PGA of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded on a scale ranging from 1=very good (no symptom and 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 and inability to carry out all normal activities). Higher scores indicated worse condition.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). BOCF method was used to impute missing values. Here, 'overall number of participants' signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Placebo Tanezumab 5 mg + Placebo Tanezumab 10 mg + Placebo Naproxen + Placebo
Hide Arm/Group Description:
Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.
Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.
Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.
Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
Overall Number of Participants Analyzed 209 211 208 207
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 3.46  (0.65) 3.36  (0.56) 3.40  (0.61) 3.48  (0.61)
Change at Week 16 -0.49  (0.80) -0.80  (0.89) -0.80  (1.00) -0.66  (0.90)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg + Placebo
Comments ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.34
Confidence Interval (2-Sided) 95%
-0.50 to -0.18
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.08
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg + Placebo
Comments ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.32
Confidence Interval (2-Sided) 95%
-0.48 to -0.16
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.08
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Naproxen + Placebo
Comments ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.078
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.14
Confidence Interval (2-Sided) 95%
-0.30 to 0.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.08
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg + Placebo, Naproxen + Placebo
Comments ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.019
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.19
Confidence Interval (2-Sided) 95%
-0.35 to -0.03
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.08
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg + Placebo, Naproxen + Placebo
Comments ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.029
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.18
Confidence Interval (2-Sided) 95%
-0.34 to -0.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.08
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8, and 12: Baseline Observation Carried Forward (BOCF)
Hide Description WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
Time Frame Baseline, Weeks 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). BOCF method was used to impute missing values. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Placebo Tanezumab 5 mg + Placebo Tanezumab 10 mg + Placebo Naproxen + Placebo
Hide Arm/Group Description:
Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.
Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.
Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.
Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
Overall Number of Participants Analyzed 209 211 208 207
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at Week 2 -2.11  (2.15) -2.64  (2.48) -2.42  (2.64) -2.92  (2.42)
Change at Week 4 -2.29  (2.38) -3.48  (2.55) -3.27  (2.82) -2.98  (2.33)
Change at Week 8 -2.23  (2.46) -3.46  (2.65) -3.06  (2.81) -2.85  (2.39)
Change at Week 12 -2.12  (2.69) -3.40  (2.76) -3.24  (3.02) -2.78  (2.63)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg + Placebo
Comments Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.029
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.49
Confidence Interval (2-Sided) 95%
-0.94 to -0.05
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg + Placebo
Comments Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.214
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.28
Confidence Interval (2-Sided) 95%
-0.73 to 0.16
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Naproxen + Placebo
Comments Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.76
Confidence Interval (2-Sided) 95%
-1.21 to -0.32
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg + Placebo, Naproxen + Placebo
Comments Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.234
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.27
Confidence Interval (2-Sided) 95%
-0.18 to 0.72
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg + Placebo, Naproxen + Placebo
Comments Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.034
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.48
Confidence Interval (2-Sided) 95%
0.04 to 0.93
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg + Placebo
Comments Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.16
Confidence Interval (2-Sided) 95%
-1.63 to -0.70
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg + Placebo
Comments Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.96
Confidence Interval (2-Sided) 95%
-1.42 to -0.49
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Naproxen + Placebo
Comments Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.64
Confidence Interval (2-Sided) 95%
-1.11 to -0.18
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg + Placebo, Naproxen + Placebo
Comments Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.029
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.52
Confidence Interval (2-Sided) 95%
-0.99 to -0.05
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg + Placebo, Naproxen + Placebo
Comments Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.193
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.31
Confidence Interval (2-Sided) 95%
-0.78 to 0.16
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg + Placebo
Comments Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.20
Confidence Interval (2-Sided) 95%
-1.68 to -0.73
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg + Placebo
Comments Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.80
Confidence Interval (2-Sided) 95%
-1.28 to -0.32
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo, Naproxen + Placebo
Comments Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.62
Confidence Interval (2-Sided) 95%
-1.10 to -0.14
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg + Placebo, Naproxen + Placebo
Comments Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.58
Confidence Interval (2-Sided) 95%
-1.06 to -0.10
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg + Placebo, Naproxen + Placebo
Comments Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.464
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.18
Confidence Interval (2-Sided) 95%
-0.66 to 0.30
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg + Placebo
Comments Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.22
Confidence Interval (2-Sided) 95%
-1.72 to -0.72
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.26
Estimation Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg + Placebo
Comments Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.04
Confidence Interval (2-Sided) 95%
-1.55 to -0.54
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.26
Estimation Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Placebo, Naproxen + Placebo
Comments Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.63
Confidence Interval (2-Sided) 95%
-1.14 to -0.13
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.26
Estimation Comments [Not Specified]
Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg + Placebo, Naproxen + Placebo
Comments Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.023
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.59
Confidence Interval (2-Sided) 95%
-1.09 to -0.08
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.26
Estimation Comments [Not Specified]
Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg + Placebo, Naproxen + Placebo
Comments Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.114
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.41
Confidence Interval (2-Sided) 95%
-0.92 to 0.10
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.26
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
Hide Description WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
Time Frame Baseline, Weeks 2, 4, 8, 12, and 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). LOCF method was used to impute missing values. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Placebo Tanezumab 5 mg + Placebo Tanezumab 10 mg + Placebo Naproxen + Placebo
Hide Arm/Group Description:
Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.
Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.
Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.
Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
Overall Number of Participants Analyzed 209 211 208 207
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 7.41  (1.38) 7.27  (1.38) 7.37  (1.39) 7.30  (1.41)
Change at Week 2 -2.11  (2.15) -2.64  (2.48) -2.42  (2.64) -2.92  (2.42)
Change at Week 4 -2.42  (2.36) -3.57  (2.49) -3.35  (2.79) -3.04  (2.35)
Change at Week 8 -2.48  (2.39) -3.59  (2.57) -3.39  (2.75) -3.05  (2.39)
Change at Week 12 -2.58  (2.63) -3.79  (2.58) -3.73  (2.84) -3.12  (2.56)
Change at Week 16 -2.64  (2.67) -3.80  (2.58) -3.58  (2.87) -3.07  (2.66)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg + Placebo
Comments Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.029
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.49
Confidence Interval (2-Sided) 95%
-0.94 to -0.05
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg + Placebo
Comments Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.214
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.28
Confidence Interval (2-Sided) 95%
-0.73 to 0.16
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Naproxen + Placebo
Comments Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.76
Confidence Interval (2-Sided) 95%
-1.21 to -0.32
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg + Placebo, Naproxen + Placebo
Comments Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.234
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.27
Confidence Interval (2-Sided) 95%
-0.18 to 0.72
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg + Placebo, Naproxen + Placebo
Comments Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.034
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.48
Confidence Interval (2-Sided) 95%
0.04 to 0.93
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg + Placebo
Comments Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.13
Confidence Interval (2-Sided) 95%
-1.59 to -0.67
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg + Placebo
Comments Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.91
Confidence Interval (2-Sided) 95%
-1.37 to -0.45
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Naproxen + Placebo
Comments Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.59
Confidence Interval (2-Sided) 95%
-1.05 to -0.13
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg + Placebo, Naproxen + Placebo
Comments Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.023
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.54
Confidence Interval (2-Sided) 95%
-1.00 to -0.07
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg + Placebo, Naproxen + Placebo
Comments Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.175
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
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 [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg + Placebo
Comments Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.09
Confidence Interval (2-Sided) 95%
-1.55 to -0.63
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg + Placebo
Comments Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.88
Confidence Interval (2-Sided) 95%
-1.34 to -0.41
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo, Naproxen + Placebo
Comments Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.56
Confidence Interval (2-Sided) 95%
-1.03 to -0.10
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg + Placebo, Naproxen + Placebo
Comments Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.027
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.52
Confidence Interval (2-Sided) 95%
-0.99 to -0.06
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg + Placebo, Naproxen + Placebo
Comments Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.190
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.31
Confidence Interval (2-Sided) 95%
-0.78 to 0.15
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg + Placebo
Comments Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.15
Confidence Interval (2-Sided) 95%
-1.63 to -0.68
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg + Placebo
Comments Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.07
Confidence Interval (2-Sided) 95%
-1.55 to -0.60
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Placebo, Naproxen + Placebo
Comments Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.034
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.52
Confidence Interval (2-Sided) 95%
-0.99 to -0.04
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg + Placebo, Naproxen + Placebo
Comments Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.64
Confidence Interval (2-Sided) 9%
-1.12 to -0.16
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg + Placebo, Naproxen + Placebo
Comments Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.023
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.56
Confidence Interval (2-Sided) 95%
-1.04 to -0.08
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg + Placebo
Comments Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.12
Confidence Interval (2-Sided) 95%
-1.60 to -0.64
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg + Placebo
Comments Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.87
Confidence Interval (2-Sided) 95%
-1.35 to -0.39
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.25
Estimation Comments [Not Specified]
Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Placebo, Naproxen + Placebo
Comments Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.092
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.41
Confidence Interval (2-Sided) 95%
-0.90 to 0.07
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.25
Estimation Comments [Not Specified]
Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg + Placebo, Naproxen + Placebo
Comments Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.71
Confidence Interval (2-Sided) 95%
-1.19 to -0.23
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.25
Estimation Comments [Not Specified]
Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg + Placebo, Naproxen + Placebo
Comments Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.064
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.46
Confidence Interval (2-Sided) 95%
-0.94 to 0.03
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.25
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)
Hide Description WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function.
Time Frame Baseline, Weeks 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). BOCF method was used to impute missing values. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Placebo Tanezumab 5 mg + Placebo Tanezumab 10 mg + Placebo Naproxen + Placebo
Hide Arm/Group Description:
Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.
Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.
Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.
Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
Overall Number of Participants Analyzed 209 211 208 207
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 7.04  (1.49) 6.83  (1.56) 7.09  (1.52) 6.95  (1.64)
Change at Week 2 -1.60  (2.12) -2.34  (2.37) -2.33  (2.50) -2.52  (2.40)
Change at Week 4 -1.77  (2.24) -3.04  (2.50) -2.94  (2.80) -2.55  (2.36)
Change at Week 8 -1.76  (2.31) -3.00  (2.61) -2.83  (2.79) -2.40  (2.29)
Change at Week 12 -1.71  (2.49) -3.06  (2.66) -2.95  (2.95) -2.47  (2.45)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg + Placebo
Comments Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.70
Confidence Interval (2-Sided) 95%
-1.12 to -0.27
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.22
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg + Placebo
Comments Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.66
Confidence Interval (2-Sided) 95%
-1.09 to -0.23
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.22
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Naproxen + Placebo
Comments Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.82
Confidence Interval (2-Sided) 95%
-1.25 to -0.39
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.22
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg + Placebo, Naproxen + Placebo
Comments Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.572
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.12
Confidence Interval (2-Sided) 95%
-0.31 to 0.55
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.22
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg + Placebo, Naproxen + Placebo
Comments Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.467
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.16
Confidence Interval (2-Sided) 95%
-0.27 to 0.59
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.22
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg + Placebo
Comments Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.28
Confidence Interval (2-Sided) 95%
-1.74 to -0.83
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg + Placebo
Comments Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.12
Confidence Interval (2-Sided) 95%
-1.58 to -0.66
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Naproxen + Placebo
Comments Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.73
Confidence Interval (2-Sided) 95%
-1.19 to -0.27
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg + Placebo, Naproxen + Placebo
Comments Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.019
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.55
Confidence Interval (2-Sided) 95%
-1.01 to -0.09
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg + Placebo, Naproxen + Placebo
Comments Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.101
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.39
Confidence Interval (2-Sided) 95%
-0.85 to 0.08
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg + Placebo
Comments Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.24
Confidence Interval (2-Sided) 95%
-1.70 to -0.78
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg + Placebo
Comments Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.00
Confidence Interval (2-Sided) 95%
-1.47 to -0.54
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo, Naproxen + Placebo
Comments Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.62
Confidence Interval (2-Sided) 95%
-1.08 to -0.16
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg + Placebo, Naproxen + Placebo
Comments Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.62
Confidence Interval (2-Sided) 95%
-1.08 to -0.16
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg + Placebo, Naproxen + Placebo
Comments Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.101
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.39
Confidence Interval (2-Sided) 95%
-0.85 to 0.08
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg + Placebo
Comments Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.31
Confidence Interval (2-Sided) 95%
-1.79 to -0.83
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg + Placebo
Comments Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.15
Confidence Interval (2-Sided) 95%
-1.63 to -0.67
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.25
Estimation Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Placebo, Naproxen + Placebo
Comments Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.72
Confidence Interval (2-Sided) 95%
-1.21 to -0.24
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.25
Estimation Comments [Not Specified]
Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg + Placebo, Naproxen + Placebo
Comments Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.59
Confidence Interval (2-Sided) 95%
-1.08 to -0.11
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.25
Estimation Comments [Not Specified]
Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg + Placebo, Naproxen + Placebo
Comments Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.082
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.43
Confidence Interval (2-Sided) 95%
-0.91 to 0.06
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.25
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
Hide Description WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function.
Time Frame Baseline, Weeks 2, 4, 8, 12, and 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). LOCF method was used to impute missing values. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Placebo Tanezumab 5 mg + Placebo Tanezumab 10 mg + Placebo Naproxen + Placebo
Hide Arm/Group Description:
Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.
Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.
Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.
Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
Overall Number of Participants Analyzed 209 211 208 207
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at Week 2 -1.60  (2.12) -2.34  (2.37) -2.33  (2.50) -2.52  (2.40)
Change at Week 4 -1.84  (2.25) -3.09  (2.49) -3.05  (2.78) -2.58  (2.37)
Change at Week 8 -1.92  (2.29) -3.13  (2.57) -3.10  (2.76) -2.56  (2.34)
Change at Week 12 -2.03  (2.52) -3.36  (2.58) -3.36  (2.85) -2.70  (2.49)
Change at Week 16 -2.08  (2.55) -3.38  (2.57) -3.30  (2.87) -2.60  (2.59)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg + Placebo
Comments Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.70
Confidence Interval (2-Sided) 95%
-1.12 to -0.27
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.22
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg + Placebo
Comments Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.66
Confidence Interval (2-Sided) 95%
-1.09 to -0.23
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.22
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Naproxen + Placebo
Comments Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.82
Confidence Interval (2-Sided) 95%
-1.25 to -0.39
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.22
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg + Placebo, Naproxen + Placebo
Comments Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.572
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.12
Confidence Interval (2-Sided) 95%
-0.31 to 0.55
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.22
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg + Placebo, Naproxen + Placebo
Comments Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.467
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.16
Confidence Interval (2-Sided) 95%
-0.27 to 0.59
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.22
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg + Placebo
Comments Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.27
Confidence Interval (2-Sided) 95%
-1.73 to -0.82
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg + Placebo
Comments Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.15
Confidence Interval (2-Sided) 95%
-1.61 to -0.70
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Naproxen + Placebo
Comments Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.70
Confidence Interval (2-Sided) 95%
-1.16 to -0.24
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg + Placebo, Naproxen + Placebo
Comments Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.57
Confidence Interval (2-Sided) 95%
-1.03 to -0.11
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg + Placebo, Naproxen + Placebo
Comments Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.053
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.45
Confidence Interval (2-Sided) 95%
-0.91 to 0.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg + Placebo
Comments Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.21
Confidence Interval (2-Sided) 95%
-1.66 to -0.75
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg + Placebo
Comments Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.11
Confidence Interval (2-Sided) 95%
-1.56 to -0.65
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo, Naproxen + Placebo
Comments Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.61
Confidence Interval (2-Sided) 95%
-1.07 to -0.16
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg + Placebo, Naproxen + Placebo
Comments Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.59
Confidence Interval (2-Sided) 95%
-1.05 to -0.14
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg + Placebo, Naproxen + Placebo
Comments Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.035
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.49
Confidence Interval (2-Sided) 95%
-0.95 to -0.03
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg + Placebo
Comments Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.32
Confidence Interval (2-Sided) 95%
-1.79 to -0.85
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg + Placebo
Comments Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.24
Confidence Interval (2-Sided) 95%
-1.71 to -0.76
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Placebo, Naproxen + Placebo
Comments Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.64
Confidence Interval (2-Sided) 95%
-1.11 to -0.16
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg + Placebo, Naproxen + Placebo
Comments Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.68
Confidence Interval (2-Sided) 95%
-1.16 to -0.21
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg + Placebo, Naproxen + Placebo
Comments Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.60
Confidence Interval (2-Sided) 95%
-1.07 to -0.12
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg + Placebo
Comments Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.29
Confidence Interval (2-Sided) 95%
-1.76 to -0.81
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg + Placebo
Comments Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.11
Confidence Interval (2-Sided) 95%
-1.58 to -0.63
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Placebo, Naproxen + Placebo
Comments Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.050
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.47
Confidence Interval (2-Sided) 95%
-0.95 to -0.00
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg + Placebo, Naproxen + Placebo
Comments Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.81
Confidence Interval (2-Sided) 95%
-1.29 to -0.34
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg + Placebo, Naproxen + Placebo
Comments Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.63
Confidence Interval (2-Sided) 95%
-1.11 to -0.16
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)
Hide Description Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded on a scale ranging from 1=very good (no symptom and 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 and inability to carry out all normal activities). Higher scores indicated worse condition.
Time Frame Baseline, Weeks 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). BOCF method was used to impute missing values. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Placebo Tanezumab 5 mg + Placebo Tanezumab 10 mg + Placebo Naproxen + Placebo
Hide Arm/Group Description:
Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.
Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.
Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.
Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
Overall Number of Participants Analyzed 209 211 208 207
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at Week 2 -0.52  (0.87) -0.65  (0.90) -0.60  (0.99) -0.88  (0.85)
Change at Week 4 -0.55  (0.84) -0.90  (0.98) -0.93  (1.03) -0.85  (0.83)
Change at Week 8 -0.51  (0.84) -0.91  (0.91) -0.85  (1.01) -0.71  (0.86)
Change at Week 12 -0.55  (0.85) -0.85  (0.93) -0.80  (0.93) -0.65  (0.83)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg + Placebo
Comments Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.20
Confidence Interval (2-Sided) 95%
-0.35 to -0.04
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.08
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg + Placebo
Comments Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.113
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.12
Confidence Interval (2-Sided) 95%
-0.28 to 0.03
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.08
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Naproxen + Placebo
Comments Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.34
Confidence Interval (2-Sided) 95%
-0.49 to -0.18
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.08
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg + Placebo, Naproxen + Placebo
Comments Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.076
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.14
Confidence Interval (2-Sided) 95%
-0.01 to 0.29
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.08
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg + Placebo, Naproxen + Placebo
Comments Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.21
Confidence Interval (2-Sided) 95%
0.06 to 0.37
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.08
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg + Placebo
Comments Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.40
Confidence Interval (2-Sided) 95%
-0.56 to -0.24
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.08
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg + Placebo
Comments Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.42
Confidence Interval (2-Sided) 95%
-0.58 to -0.26
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.08
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Naproxen + Placebo
Comments Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was based on pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.27
Confidence Interval (2-Sided) 95%
-0.43 to -0.11
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.08
Estimation Comments [Not Specified]