Trial Outcomes & Findings for RN624 For Pain Of Post-Herpetic Neuralgia (NCT NCT00568321)

Last Updated: 2021-05-28

Results Overview

Participants assessed their average daily pain during the past 24 hours on an 11--point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Week 6 score was calculated as the mean of average daily pain NRS scores over the past 7 days. The change from baseline was calculated using difference between Week 6 mean score and Baseline mean score.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

99 participants

Primary outcome timeframe

Baseline, Week 6

Results posted on

2021-05-28

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Tanezumab 50 mcg/kg Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Tanezumab 200 mcg/kg Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Overall Study STARTED	33	33	33
Overall Study Treated	31	33	32
Overall Study COMPLETED	20	28	24
Overall Study NOT COMPLETED	13	5	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Tanezumab 50 mcg/kg Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Tanezumab 200 mcg/kg Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Overall Study Adverse Event	1	0	0
Overall Study Lack of Efficacy	8	5	6
Overall Study Lost to Follow-up	0	0	1
Overall Study Withdrawal by Subject	2	0	0
Overall Study Protocol Violation	0	0	1
Overall Study Randomized, not treated	2	0	1

Baseline Characteristics

RN624 For Pain Of Post-Herpetic Neuralgia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=31 Participants Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Tanezumab 50 mcg/kg n=33 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Tanezumab 200 mcg/kg n=32 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).	Total n=96 Participants Total of all reporting groups
Age, Continuous	70.9 years STANDARD_DEVIATION 8.7 • n=93 Participants	71.9 years STANDARD_DEVIATION 8.5 • n=4 Participants	65.9 years STANDARD_DEVIATION 14.6 • n=27 Participants	69.6 years STANDARD_DEVIATION 11.2 • n=483 Participants
Sex: Female, Male Female	13 Participants n=93 Participants	16 Participants n=4 Participants	15 Participants n=27 Participants	44 Participants n=483 Participants
Sex: Female, Male Male	18 Participants n=93 Participants	17 Participants n=4 Participants	17 Participants n=27 Participants	52 Participants n=483 Participants

PRIMARY outcome

Timeframe: Baseline, Week 6

Population: Intent-to-treat (ITT) population included all randomized participants who received the Day 1 IV infusion (either tanezumab or placebo). Here, "number analyzed (n)" signifies those participants who were evaluable at given time points.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Tanezumab 50 mcg/kg n=33 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Tanezumab 200 mcg/kg n=32 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Week 6 Baseline	6.40 units on a scale Standard Deviation 1.55	6.42 units on a scale Standard Deviation 1.57	6.39 units on a scale Standard Deviation 1.58
Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Week 6 Change at Week 6	-1.22 units on a scale Standard Deviation 1.72	-0.97 units on a scale Standard Deviation 1.20	-1.72 units on a scale Standard Deviation 2.40

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 4, 8, 12, 16

Population: ITT population included all randomized participants who received the Day 1 IV infusion (either tanezumab or placebo). Here, "number analyzed" signifies those participants who were evaluable at given time points.

Participants assessed their average daily pain during the past 24 hours on an 11--point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Post Baseline weekly scores were calculated as the mean of average daily pain NRS scores over the past 7 days prior to corresponding week visits. The change from baseline was calculated using difference between post baseline weekly mean score and the Baseline mean score.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Tanezumab 50 mcg/kg n=33 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Tanezumab 200 mcg/kg n=32 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16 Change at Week 1	-0.54 units on a scale Standard Deviation 1.25	-0.64 units on a scale Standard Deviation 1.19	-0.91 units on a scale Standard Deviation 1.36
Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16 Change at Week 2	-0.80 units on a scale Standard Deviation 1.65	-0.46 units on a scale Standard Deviation 1.42	-0.66 units on a scale Standard Deviation 1.73
Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16 Change at Week 4	-1.30 units on a scale Standard Deviation 1.61	-0.97 units on a scale Standard Deviation 1.15	-1.46 units on a scale Standard Deviation 1.91
Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16 Change at Week 8	-1.18 units on a scale Standard Deviation 1.47	-1.10 units on a scale Standard Deviation 1.36	-1.72 units on a scale Standard Deviation 2.34
Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16 Change at Week 12	-1.13 units on a scale Standard Deviation 1.46	-1.49 units on a scale Standard Deviation 1.66	-1.45 units on a scale Standard Deviation 2.44
Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16 Change at Week 16	-1.18 units on a scale Standard Deviation 1.61	-1.70 units on a scale Standard Deviation 1.78	-1.76 units on a scale Standard Deviation 2.47

SECONDARY outcome

Timeframe: Baseline, Week 1 to 4, Week 1 to 8, Week 1 to 12, Week 1 to 16, Week 5 to 8, Week 5 to 12, Week 5 to 16

Participants assessed their average daily pain during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Scores for each time interval over the weeks were calculated from the mean of daily pain score of participants over that specified duration. Change from baseline was calculated as the average of each specified week interval (Week 1 to 4, 1 to 8, 1 to 12, 5 to 8, 5 to 12 and 5 to 16) values minus the baseline value.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Tanezumab 50 mcg/kg n=33 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Tanezumab 200 mcg/kg n=32 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score Over Weeks 1 to 4, 1 to 8, 1 to 12, 1 to 16, 5 to 8, 5 to 12 and 5 to 16 Weeks 1 to 4	-0.87 units on a scale Standard Deviation 1.43	-0.70 units on a scale Standard Deviation 1.13	-1.08 units on a scale Standard Deviation 1.53
Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score Over Weeks 1 to 4, 1 to 8, 1 to 12, 1 to 16, 5 to 8, 5 to 12 and 5 to 16 Weeks 1 to 8	-0.97 units on a scale Standard Deviation 1.37	-0.81 units on a scale Standard Deviation 1.03	-1.35 units on a scale Standard Deviation 1.74
Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score Over Weeks 1 to 4, 1 to 8, 1 to 12, 1 to 16, 5 to 8, 5 to 12 and 5 to 16 Weeks 1 to 12	-1.01 units on a scale Standard Deviation 1.25	-0.97 units on a scale Standard Deviation 1.07	-1.38 units on a scale Standard Deviation 1.75
Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score Over Weeks 1 to 4, 1 to 8, 1 to 12, 1 to 16, 5 to 8, 5 to 12 and 5 to 16 Weeks 1 to 16	-1.02 units on a scale Standard Deviation 1.17	-1.03 units on a scale Standard Deviation 1.16	-1.43 units on a scale Standard Deviation 1.81
Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score Over Weeks 1 to 4, 1 to 8, 1 to 12, 1 to 16, 5 to 8, 5 to 12 and 5 to 16 Weeks 5 to 8	-1.18 units on a scale Standard Deviation 1.50	-1.01 units on a scale Standard Deviation 1.15	-1.61 units on a scale Standard Deviation 2.21
Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score Over Weeks 1 to 4, 1 to 8, 1 to 12, 1 to 16, 5 to 8, 5 to 12 and 5 to 16 Weeks 5 to 12	-1.19 units on a scale Standard Deviation 1.34	-1.20 units on a scale Standard Deviation 1.27	-1.50 units on a scale Standard Deviation 2.08
Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score Over Weeks 1 to 4, 1 to 8, 1 to 12, 1 to 16, 5 to 8, 5 to 12 and 5 to 16 Weeks 5 to 16	-1.19 units on a scale Standard Deviation 1.27	-1.25 units on a scale Standard Deviation 1.38	-1.52 units on a scale Standard Deviation 2.13

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 2, 4, 6, 8 ,12, 16

Population: ITT population included all randomized participants who received Day 1 IV infusion (either tanezumab or placebo). Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at given time points.

mBPI-sf is a self-administered questionnaire (5 questions) to assess pain severity and impact of pain on daily functions. Questions 1 to 4 measure the magnitude of pain (Q1 for worst, Q2 for least, Q3 for average and Q4 for pain right now) on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicate less pain. Question 5 consists of 7 item subsets which measure the level of interference of pain on daily functions: 1: general activity, 2: mood, 3: walking ability, 4: normal work, 5: relations with other, 6: sleep, 7: enjoyment of life. Each item assessed on an 11-point NRS ranging from 0 (no interference) to 10 (complete interference), where lower scores indicate less interference of pain. Pain severity score was derived from the sum of responses of questions 1-4 and ranged from 0 (no pain) to 40 (worst possible pain) with lower scores indicates less pain. Results are reported for worst pain score, average pain score and pain severity score.

Outcome measures

Outcome measures
Measure	Placebo n=30 Participants Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Tanezumab 50 mcg/kg n=32 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Tanezumab 200 mcg/kg n=30 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) Scale Score for Worst Pain, Average Pain and Pain Severity at Weeks 1, 2, 4, 6, 8 ,12 and 16 Baseline: Worst Pain	7.13 units on a scale Standard Deviation 1.57	6.78 units on a scale Standard Deviation 1.79	6.93 units on a scale Standard Deviation 1.48
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) Scale Score for Worst Pain, Average Pain and Pain Severity at Weeks 1, 2, 4, 6, 8 ,12 and 16 Baseline: Average Pain	6.27 units on a scale Standard Deviation 1.46	6.06 units on a scale Standard Deviation 1.72	6.20 units on a scale Standard Deviation 1.58
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) Scale Score for Worst Pain, Average Pain and Pain Severity at Weeks 1, 2, 4, 6, 8 ,12 and 16 Baseline: Pain Severity	24.77 units on a scale Standard Deviation 6.43	23.78 units on a scale Standard Deviation 7.23	23.87 units on a scale Standard Deviation 5.90
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) Scale Score for Worst Pain, Average Pain and Pain Severity at Weeks 1, 2, 4, 6, 8 ,12 and 16 Change at Week 1: Worst Pain	-1.10 units on a scale Standard Deviation 2.08	-0.57 units on a scale Standard Deviation 2.22	-0.71 units on a scale Standard Deviation 1.58
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) Scale Score for Worst Pain, Average Pain and Pain Severity at Weeks 1, 2, 4, 6, 8 ,12 and 16 Change at Week 1: Average Pain	-0.83 units on a scale Standard Deviation 1.54	-0.46 units on a scale Standard Deviation 1.43	-0.79 units on a scale Standard Deviation 1.55
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) Scale Score for Worst Pain, Average Pain and Pain Severity at Weeks 1, 2, 4, 6, 8 ,12 and 16 Change at Week 1: Pain Severity	-3.59 units on a scale Standard Deviation 7.06	-1.82 units on a scale Standard Deviation 6.42	-2.79 units on a scale Standard Deviation 6.64
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) Scale Score for Worst Pain, Average Pain and Pain Severity at Weeks 1, 2, 4, 6, 8 ,12 and 16 Change at Week 2: Worst Pain	-1.38 units on a scale Standard Deviation 2.14	-0.52 units on a scale Standard Deviation 1.92	-0.96 units on a scale Standard Deviation 2.51
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) Scale Score for Worst Pain, Average Pain and Pain Severity at Weeks 1, 2, 4, 6, 8 ,12 and 16 Change at Week 2: Average Pain	-1.19 units on a scale Standard Deviation 1.72	-0.41 units on a scale Standard Deviation 1.18	-0.85 units on a scale Standard Deviation 2.24
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) Scale Score for Worst Pain, Average Pain and Pain Severity at Weeks 1, 2, 4, 6, 8 ,12 and 16 Change at Week 2: Pain Severity	-5.31 units on a scale Standard Deviation 7.17	-1.86 units on a scale Standard Deviation 5.88	-3.58 units on a scale Standard Deviation 9.38
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) Scale Score for Worst Pain, Average Pain and Pain Severity at Weeks 1, 2, 4, 6, 8 ,12 and 16 Change at Week 4: Worst Pain	-1.44 units on a scale Standard Deviation 2.26	-0.93 units on a scale Standard Deviation 1.15	-1.18 units on a scale Standard Deviation 2.21
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) Scale Score for Worst Pain, Average Pain and Pain Severity at Weeks 1, 2, 4, 6, 8 ,12 and 16 Change at Week 4: Average Pain	-1.44 units on a scale Standard Deviation 1.64	-0.75 units on a scale Standard Deviation 1.04	-1.39 units on a scale Standard Deviation 2.11
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) Scale Score for Worst Pain, Average Pain and Pain Severity at Weeks 1, 2, 4, 6, 8 ,12 and 16 Change at Week 4: Pain Severity	-5.68 units on a scale Standard Deviation 7.40	-3.82 units on a scale Standard Deviation 4.26	-5.21 units on a scale Standard Deviation 8.80
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) Scale Score for Worst Pain, Average Pain and Pain Severity at Weeks 1, 2, 4, 6, 8 ,12 and 16 Change at Week 6: Worst Pain	-1.24 units on a scale Standard Deviation 1.76	-0.93 units on a scale Standard Deviation 1.57	-1.76 units on a scale Standard Deviation 2.74
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) Scale Score for Worst Pain, Average Pain and Pain Severity at Weeks 1, 2, 4, 6, 8 ,12 and 16 Change at Week 6: Average Pain	-1.19 units on a scale Standard Deviation 1.63	-0.78 units on a scale Standard Deviation 1.34	-1.72 units on a scale Standard Deviation 2.39
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) Scale Score for Worst Pain, Average Pain and Pain Severity at Weeks 1, 2, 4, 6, 8 ,12 and 16 Change at Week 6: Pain Severity	-4.57 units on a scale Standard Deviation 5.81	-4.07 units on a scale Standard Deviation 4.95	-7.00 units on a scale Standard Deviation 10.39
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) Scale Score for Worst Pain, Average Pain and Pain Severity at Weeks 1, 2, 4, 6, 8 ,12 and 16 Change at Week 8: Worst Pain	-2.00 units on a scale Standard Deviation 1.56	-1.26 units on a scale Standard Deviation 2.09	-1.81 units on a scale Standard Deviation 3.16
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) Scale Score for Worst Pain, Average Pain and Pain Severity at Weeks 1, 2, 4, 6, 8 ,12 and 16 Change at Week 8: Average Pain	-1.60 units on a scale Standard Deviation 1.54	-0.96 units on a scale Standard Deviation 1.43	-1.77 units on a scale Standard Deviation 2.44
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) Scale Score for Worst Pain, Average Pain and Pain Severity at Weeks 1, 2, 4, 6, 8 ,12 and 16 Change at Week 8: Pain Severity	-7.60 units on a scale Standard Deviation 5.22	-5.04 units on a scale Standard Deviation 5.78	-6.65 units on a scale Standard Deviation 10.55
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) Scale Score for Worst Pain, Average Pain and Pain Severity at Weeks 1, 2, 4, 6, 8 ,12 and 16 Change at Week 12: Worst Pain	-1.67 units on a scale Standard Deviation 1.49	-1.50 units on a scale Standard Deviation 2.09	-1.64 units on a scale Standard Deviation 3.28
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) Scale Score for Worst Pain, Average Pain and Pain Severity at Weeks 1, 2, 4, 6, 8 ,12 and 16 Change at Week 12: Average Pain	-1.38 units on a scale Standard Deviation 1.50	-1.17 units on a scale Standard Deviation 1.49	-1.56 units on a scale Standard Deviation 2.45
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) Scale Score for Worst Pain, Average Pain and Pain Severity at Weeks 1, 2, 4, 6, 8 ,12 and 16 Change at Week 12: Pain Severity	-5.76 units on a scale Standard Deviation 6.03	-5.83 units on a scale Standard Deviation 7.24	-5.60 units on a scale Standard Deviation 10.38
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) Scale Score for Worst Pain, Average Pain and Pain Severity at Weeks 1, 2, 4, 6, 8 ,12 and 16 Change at Week 16: Worst Pain	-1.90 units on a scale Standard Deviation 1.37	-1.63 units on a scale Standard Deviation 2.26	-2.38 units on a scale Standard Deviation 3.06
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) Scale Score for Worst Pain, Average Pain and Pain Severity at Weeks 1, 2, 4, 6, 8 ,12 and 16 Change at Week 16: Average Pain	-1.50 units on a scale Standard Deviation 1.28	-1.25 units on a scale Standard Deviation 1.78	-1.95 units on a scale Standard Deviation 2.62
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) Scale Score for Worst Pain, Average Pain and Pain Severity at Weeks 1, 2, 4, 6, 8 ,12 and 16 Change at Week 16: Pain Severity	-6.40 units on a scale Standard Deviation 4.91	-6.17 units on a scale Standard Deviation 7.95	-8.38 units on a scale Standard Deviation 10.21

SECONDARY outcome

Timeframe: Week 1, 2, 4, 6, 8, 12, 16

Participants assessed their average daily pain during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Post-baseline weekly scores were calculated as the mean of average daily pain NRS scores over the past 7 days for each specified time point. Number of participants with average daily pain score of \<=2 were reported.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Tanezumab 50 mcg/kg n=33 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Tanezumab 200 mcg/kg n=32 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Number of Participants With Mean Average Daily Pain Score of Less Than or Equal to (<=) 2 at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 1	0 Participants	2 Participants	1 Participants
Number of Participants With Mean Average Daily Pain Score of Less Than or Equal to (<=) 2 at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 2	1 Participants	2 Participants	1 Participants
Number of Participants With Mean Average Daily Pain Score of Less Than or Equal to (<=) 2 at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 4	1 Participants	0 Participants	2 Participants
Number of Participants With Mean Average Daily Pain Score of Less Than or Equal to (<=) 2 at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 6	2 Participants	2 Participants	7 Participants
Number of Participants With Mean Average Daily Pain Score of Less Than or Equal to (<=) 2 at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 8	2 Participants	1 Participants	6 Participants
Number of Participants With Mean Average Daily Pain Score of Less Than or Equal to (<=) 2 at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 12	3 Participants	4 Participants	4 Participants
Number of Participants With Mean Average Daily Pain Score of Less Than or Equal to (<=) 2 at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 16	2 Participants	4 Participants	4 Participants

SECONDARY outcome

Timeframe: Baseline, Week 6

Population: ITT population included all randomized participants who received the Day 1 IV infusion (either tanezumab or placebo). Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

Participants assessed their average daily pain during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Week 6 score was calculated as the mean of average daily pain NRS scores over the past 7 days for each specified time point. Number of participants with specified percentage (%) of reduction in average daily pain scores from baseline at Week 6 were reported. Participants were counted more than once in different categories.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Tanezumab 50 mcg/kg n=33 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Tanezumab 200 mcg/kg n=32 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6 Greater than 0% reduction	19 Participants	22 Participants	19 Participants
Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6 Greater than or equal to (>=)10% reduction	15 Participants	15 Participants	17 Participants
Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6 >=20% reduction	13 Participants	11 Participants	14 Participants
Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6 >=30% reduction	7 Participants	7 Participants	12 Participants
Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6 >=40% reduction	5 Participants	4 Participants	11 Participants
Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6 >=50% reduction	4 Participants	3 Participants	8 Participants
Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6 >=60% reduction	3 Participants	2 Participants	6 Participants
Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6 >=70% reduction	1 Participants	0 Participants	5 Participants
Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6 >=80% reduction	1 Participants	0 Participants	2 Participants
Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6 >=90% reduction	0 Participants	0 Participants	1 Participants
Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6 100% reduction	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Week 6

Population: ITT population included all randomized participants who received the Day 1 IV infusion (either tanezumab or placebo).

Participants assessed their average daily pain during the past 24 hours on an 11--point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Week 6 score was calculated as the mean of average daily pain NRS scores over the past 7 days before Week 6 visit. Number of participants with \>=30% or \>=50% of sustained reduction (defined as reduction that was maintained for a minimum duration of 4 consecutive days) in average daily pain scores from baseline at Week 6 were reported.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Tanezumab 50 mcg/kg n=33 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Tanezumab 200 mcg/kg n=32 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Number of Participants With at Least 30 Percent (%) and 50% Sustained Reduction From Baseline in Daily Average Pain Score at Week 6 >=30% reduction	14 Participants	14 Participants	16 Participants
Number of Participants With at Least 30 Percent (%) and 50% Sustained Reduction From Baseline in Daily Average Pain Score at Week 6 >=50% reduction	11 Participants	9 Participants	13 Participants

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 4, 6, 8, 12, 16

Participants assessed their average daily pain during the past 24 hours on an 11--point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Post-baseline weekly scores were calculated as the mean of average daily pain NRS scores over the past 7 days for each specified time point. Number of participants with \>=30% or \>=50% of reduction in average daily pain scores from baseline at Week 1, 2, 4, 6, 8, 12 and 16 were reported.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Tanezumab 50 mcg/kg n=33 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Tanezumab 200 mcg/kg n=32 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Number of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16 Week 1: >=30% reduction	4 Participants	5 Participants	5 Participants
Number of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16 Week 2: >=30% reduction	6 Participants	4 Participants	6 Participants
Number of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16 Week 4: >=30% reduction	10 Participants	8 Participants	12 Participants
Number of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16 Week 6: >=30% reduction	7 Participants	7 Participants	12 Participants
Number of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16 Week 8: >=30% reduction	5 Participants	9 Participants	13 Participants
Number of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16 Week 12: >=30% reduction	7 Participants	10 Participants	10 Participants
Number of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16 Week 16: >=30% reduction	6 Participants	10 Participants	9 Participants
Number of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16 Week 1: >=50% reduction	1 Participants	3 Participants	2 Participants
Number of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16 Week 2: >=50% reduction	2 Participants	3 Participants	2 Participants
Number of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16 Week 4: >=50% reduction	4 Participants	2 Participants	6 Participants
Number of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16 Week 6: >=50% reduction	4 Participants	3 Participants	8 Participants
Number of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16 Week 8: >=50% reduction	2 Participants	2 Participants	9 Participants
Number of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16 Week 12: >=50% reduction	6 Participants	6 Participants	7 Participants
Number of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16 Week 16: >=50% reduction	4 Participants	6 Participants	6 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 16

Population: ITT population included all randomized participants who received the Day 1 IV infusion (either tanezumab or placebo). Here, "number analyzed" signifies number of participants who had sustained response.

Time to achieve \>=30% or \>=50% sustained reduction from baseline (defined as reduction from baseline that was maintained for a total of 4 consecutive days) in average daily pain score was summarized using the Kaplan-Meier estimates. Participants assessed their average daily pain during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Tanezumab 50 mcg/kg n=33 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Tanezumab 200 mcg/kg n=32 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Time to Achieve at Least 30% (Percent) and 50% Sustained Reduction From Baseline in Average Daily Pain Score Time to >=30% Reduction	65.00 days Interval 1.0 to 65.0	NA days Median and full range was not estimable due to less than 50% of participants with events	57.00 days Interval 1.0 to 57.0
Time to Achieve at Least 30% (Percent) and 50% Sustained Reduction From Baseline in Average Daily Pain Score Time to >=50% Reduction	NA days Median and full range was not estimable due to less than 50% of participants with events	NA days Median and full range was not estimable due to less than 50% of participants with events	NA days Median and full range was not estimable due to less than 50% of participants with events

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: ITT population included all randomized participants who received the Day 1 IV infusion (either tanezumab or placebo).

Total duration of response was defined as total number of days with a reduction of \>=30% or \>=50% in average daily pain score from baseline to Week 16. Participants assessed their average daily pain during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Total duration with at least of \>=30% or \>=50% percent reduction in average daily pain NRS scores from Baseline to Week 16 were reported.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Tanezumab 50 mcg/kg n=33 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Tanezumab 200 mcg/kg n=32 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Total Duration of at Least 30 Percent (%) and 50% Reduction From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score in Participants Total duration for >=30% reduction	8.00 days Full Range 34.45 • Interval 0.0 to 103.0	2.00 days Full Range 35.44 • Interval 0.0 to 106.0	14.50 days Full Range 38.55 • Interval 0.0 to 107.0
Total Duration of at Least 30 Percent (%) and 50% Reduction From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score in Participants Total duration for >=50% reduction	0.00 days Full Range 25.93 • Interval 0.0 to 81.0	0.00 days Full Range 26.91 • Interval 0.0 to 99.0	2.50 days Full Range 33.15 • Interval 0.0 to 100.0

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 4, 6, 8, 12 and 16

mBPI-sf:questionnaire (5 questions) to assess pain severity and impact of pain on daily functions. Questions 1-4 assess magnitude of pain(Q1 for worst, Q2 for least, Q3 for average and Q4 for pain right now) on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicate less pain. Question 5 consists 7 item subsets which assess level of interference of pain on daily functions: 1: general activity (GA),2: mood, 3: walking ability, 4: normal work (NW),5: relations with other,6: sleep, 7: enjoyment of life. Each item assessed on an 11-point NRS ranging from 0 (no interference) to 10 (complete interference), where lower scores =less interference of pain. These 7 items were averaged to obtain pain interference composite score (CS), ranging from 0 (no interference) to 10 (complete interference), where lower scores =less interference of pain. Change from baseline in mBPI-sf score for pain interference with CS score, GA subtest and NW subtest were reported.

Outcome measures

Outcome measures
Measure	Placebo n=30 Participants Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Tanezumab 50 mcg/kg n=32 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Tanezumab 200 mcg/kg n=30 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Change From Baseline in Modified Brief Pain Inventory- Short Form (mBPI-sf) Score for Pain Interference With CS Score, GA Subtest and NW Subtest at Weeks 1, 2, 4, 6, 8, 12 and 16 Baseline: CS	3.87 units on a scale Standard Deviation 2.29	3.90 units on a scale Standard Deviation 2.46	4.67 units on a scale Standard Deviation 2.05
Change From Baseline in Modified Brief Pain Inventory- Short Form (mBPI-sf) Score for Pain Interference With CS Score, GA Subtest and NW Subtest at Weeks 1, 2, 4, 6, 8, 12 and 16 Baseline: GA	4.13 units on a scale Standard Deviation 2.75	4.16 units on a scale Standard Deviation 3.09	4.83 units on a scale Standard Deviation 2.28
Change From Baseline in Modified Brief Pain Inventory- Short Form (mBPI-sf) Score for Pain Interference With CS Score, GA Subtest and NW Subtest at Weeks 1, 2, 4, 6, 8, 12 and 16 Baseline: NW	3.53 units on a scale Standard Deviation 2.66	3.75 units on a scale Standard Deviation 2.93	5.00 units on a scale Standard Deviation 2.56
Change From Baseline in Modified Brief Pain Inventory- Short Form (mBPI-sf) Score for Pain Interference With CS Score, GA Subtest and NW Subtest at Weeks 1, 2, 4, 6, 8, 12 and 16 Change at Week 1: CS	-0.86 units on a scale Standard Deviation 2.56	-0.90 units on a scale Standard Deviation 1.24	-0.99 units on a scale Standard Deviation 2.28
Change From Baseline in Modified Brief Pain Inventory- Short Form (mBPI-sf) Score for Pain Interference With CS Score, GA Subtest and NW Subtest at Weeks 1, 2, 4, 6, 8, 12 and 16 Change at Week 1: GA	-0.76 units on a scale Standard Deviation 3.12	-0.57 units on a scale Standard Deviation 2.04	-1.14 units on a scale Standard Deviation 2.86
Change From Baseline in Modified Brief Pain Inventory- Short Form (mBPI-sf) Score for Pain Interference With CS Score, GA Subtest and NW Subtest at Weeks 1, 2, 4, 6, 8, 12 and 16 Change at Week 1: NW	-0.48 units on a scale Standard Deviation 2.86	-1.07 units on a scale Standard Deviation 1.36	-1.48 units on a scale Standard Deviation 2.56
Change From Baseline in Modified Brief Pain Inventory- Short Form (mBPI-sf) Score for Pain Interference With CS Score, GA Subtest and NW Subtest at Weeks 1, 2, 4, 6, 8, 12 and 16 Change at Week 2: CS	-1.47 units on a scale Standard Deviation 2.18	-0.69 units on a scale Standard Deviation 1.65	-1.23 units on a scale Standard Deviation 2.67
Change From Baseline in Modified Brief Pain Inventory- Short Form (mBPI-sf) Score for Pain Interference With CS Score, GA Subtest and NW Subtest at Weeks 1, 2, 4, 6, 8, 12 and 16 Change at Week 2: GA	-1.58 units on a scale Standard Deviation 2.84	-0.55 units on a scale Standard Deviation 2.29	-1.04 units on a scale Standard Deviation 3.49
Change From Baseline in Modified Brief Pain Inventory- Short Form (mBPI-sf) Score for Pain Interference With CS Score, GA Subtest and NW Subtest at Weeks 1, 2, 4, 6, 8, 12 and 16 Change at Week 2: NW	-1.19 units on a scale Standard Deviation 2.76	-0.59 units on a scale Standard Deviation 2.13	-1.40 units on a scale Standard Deviation 2.68
Change From Baseline in Modified Brief Pain Inventory- Short Form (mBPI-sf) Score for Pain Interference With CS Score, GA Subtest and NW Subtest at Weeks 1, 2, 4, 6, 8, 12 and 16 Change at Week 4: CS	-1.22 units on a scale Standard Deviation 1.98	-1.26 units on a scale Standard Deviation 1.66	-1.54 units on a scale Standard Deviation 2.46
Change From Baseline in Modified Brief Pain Inventory- Short Form (mBPI-sf) Score for Pain Interference With CS Score, GA Subtest and NW Subtest at Weeks 1, 2, 4, 6, 8, 12 and 16 Change at Week 4: GA	-1.28 units on a scale Standard Deviation 2.61	-1.18 units on a scale Standard Deviation 2.45	-1.57 units on a scale Standard Deviation 3.35
Change From Baseline in Modified Brief Pain Inventory- Short Form (mBPI-sf) Score for Pain Interference With CS Score, GA Subtest and NW Subtest at Weeks 1, 2, 4, 6, 8, 12 and 16 Change at Week 4: NW	-1.04 units on a scale Standard Deviation 2.09	-1.29 units on a scale Standard Deviation 1.98	-1.63 units on a scale Standard Deviation 2.71
Change From Baseline in Modified Brief Pain Inventory- Short Form (mBPI-sf) Score for Pain Interference With CS Score, GA Subtest and NW Subtest at Weeks 1, 2, 4, 6, 8, 12 and 16 Change at Week 6: CS	-1.01 units on a scale Standard Deviation 1.60	-1.20 units on a scale Standard Deviation 1.57	-1.65 units on a scale Standard Deviation 2.77
Change From Baseline in Modified Brief Pain Inventory- Short Form (mBPI-sf) Score for Pain Interference With CS Score, GA Subtest and NW Subtest at Weeks 1, 2, 4, 6, 8, 12 and 16 Change at Week 6: GA	-1.05 units on a scale Standard Deviation 2.18	-1.04 units on a scale Standard Deviation 2.14	-1.36 units on a scale Standard Deviation 3.68
Change From Baseline in Modified Brief Pain Inventory- Short Form (mBPI-sf) Score for Pain Interference With CS Score, GA Subtest and NW Subtest at Weeks 1, 2, 4, 6, 8, 12 and 16 Change at Week 6: NW	-0.62 units on a scale Standard Deviation 2.18	-1.15 units on a scale Standard Deviation 2.03	-1.63 units on a scale Standard Deviation 3.15
Change From Baseline in Modified Brief Pain Inventory- Short Form (mBPI-sf) Score for Pain Interference With CS Score, GA Subtest and NW Subtest at Weeks 1, 2, 4, 6, 8, 12 and 16 Change at Week 8: CS	-1.37 units on a scale Standard Deviation 1.75	-1.11 units on a scale Standard Deviation 1.83	-1.41 units on a scale Standard Deviation 2.60
Change From Baseline in Modified Brief Pain Inventory- Short Form (mBPI-sf) Score for Pain Interference With CS Score, GA Subtest and NW Subtest at Weeks 1, 2, 4, 6, 8, 12 and 16 Change at Week 8: GA	-1.55 units on a scale Standard Deviation 2.28	-1.04 units on a scale Standard Deviation 2.17	-1.23 units on a scale Standard Deviation 3.39
Change From Baseline in Modified Brief Pain Inventory- Short Form (mBPI-sf) Score for Pain Interference With CS Score, GA Subtest and NW Subtest at Weeks 1, 2, 4, 6, 8, 12 and 16 Change at Week 8: NW	-1.10 units on a scale Standard Deviation 2.13	-0.96 units on a scale Standard Deviation 2.23	-1.52 units on a scale Standard Deviation 2.76
Change From Baseline in Modified Brief Pain Inventory- Short Form (mBPI-sf) Score for Pain Interference With CS Score, GA Subtest and NW Subtest at Weeks 1, 2, 4, 6, 8, 12 and 16 Change at Week 12: CS	-0.89 units on a scale Standard Deviation 1.69	-1.07 units on a scale Standard Deviation 2.04	-1.25 units on a scale Standard Deviation 3.25
Change From Baseline in Modified Brief Pain Inventory- Short Form (mBPI-sf) Score for Pain Interference With CS Score, GA Subtest and NW Subtest at Weeks 1, 2, 4, 6, 8, 12 and 16 Change at Week 12: GA	-0.86 units on a scale Standard Deviation 2.54	-0.92 units on a scale Standard Deviation 2.36	-0.92 units on a scale Standard Deviation 4.08
Change From Baseline in Modified Brief Pain Inventory- Short Form (mBPI-sf) Score for Pain Interference With CS Score, GA Subtest and NW Subtest at Weeks 1, 2, 4, 6, 8, 12 and 16 Change at Week 12: NW	-0.52 units on a scale Standard Deviation 2.34	-1.00 units on a scale Standard Deviation 2.21	-1.25 units on a scale Standard Deviation 3.33
Change From Baseline in Modified Brief Pain Inventory- Short Form (mBPI-sf) Score for Pain Interference With CS Score, GA Subtest and NW Subtest at Weeks 1, 2, 4, 6, 8, 12 and 16 Change at Week 16: CS	-1.46 units on a scale Standard Deviation 1.21	-1.23 units on a scale Standard Deviation 2.02	-1.82 units on a scale Standard Deviation 3.00
Change From Baseline in Modified Brief Pain Inventory- Short Form (mBPI-sf) Score for Pain Interference With CS Score, GA Subtest and NW Subtest at Weeks 1, 2, 4, 6, 8, 12 and 16 Change at Week 16: GA	-1.40 units on a scale Standard Deviation 1.82	-1.21 units on a scale Standard Deviation 2.21	-2.10 units on a scale Standard Deviation 3.77
Change From Baseline in Modified Brief Pain Inventory- Short Form (mBPI-sf) Score for Pain Interference With CS Score, GA Subtest and NW Subtest at Weeks 1, 2, 4, 6, 8, 12 and 16 Change at Week 16: NW	-1.30 units on a scale Standard Deviation 1.78	-1.21 units on a scale Standard Deviation 2.26	-1.80 units on a scale Standard Deviation 3.16

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 4, 6, 8 ,12, 16

Patient's global assessment of pain from post-herpetic neuralgia assessed participant's overall impression of disease activity. Participants answered: "Considering all the ways your pain from post-herpetic neuralgia, how are you doing today?". Participants responded using a 5--point Likert scale with a score of 1 being the best (very good) and a score of 5 being the worst (very poor) with lower scores indicating better condition. Number of participants who reported a change from Baseline of -4, -3, -2, -1, 0, 1, 2, 3, 4 in Patient's Global Assessment of Pain scores at each specified time-point were presented.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Tanezumab 50 mcg/kg n=33 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Tanezumab 200 mcg/kg n=32 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 12: Change= -3	0 Participants	0 Participants	1 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 12: Change= -2	0 Participants	1 Participants	3 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 1: Change= --4	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 1: Change= --3	1 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 1: Change= --2	3 Participants	1 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 1: Change= --1	4 Participants	4 Participants	8 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 1: Change= 0	15 Participants	19 Participants	11 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 1: Change= 1	5 Participants	4 Participants	7 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 1: Change= 2	1 Participants	1 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 1: Change= 3	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 1: Change= 4	0 Participants	0 Participants	1 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 2: Change= --4	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 2: Change= --3	1 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 2: Change= --2	3 Participants	0 Participants	2 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 2: Change= --1	5 Participants	7 Participants	2 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 2: Change= 0	15 Participants	15 Participants	17 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 2: Change= 1	2 Participants	7 Participants	3 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 2: Change= 2	0 Participants	0 Participants	1 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 2: Change= 3	1 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 2: Change= 4	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 4: Change= --4	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 4: Change= --3	1 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 4: Change= --2	1 Participants	1 Participants	1 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 4: Change= --1	7 Participants	5 Participants	8 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 4: Change= 0	10 Participants	20 Participants	16 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 4: Change= 1	5 Participants	1 Participants	2 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 4: Change= 2	0 Participants	1 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 4: Change= 3	1 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 4: Change= 4	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 6: Change= --4	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 6: Change= --3	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 6: Change= --2	1 Participants	1 Participants	2 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 6: Change= --1	6 Participants	7 Participants	6 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 6: Change= 0	11 Participants	17 Participants	13 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 6: Change= 1	3 Participants	0 Participants	2 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 6: Change= 2	0 Participants	2 Participants	1 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 6: Change= 3	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 6: Change= 4	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 8: Change= --4	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 8: Change= --3	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 8: Change= --2	1 Participants	1 Participants	2 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 8: Change= -1	7 Participants	7 Participants	8 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 8: Change= 0	9 Participants	17 Participants	12 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 8: Change= 1	3 Participants	1 Participants	2 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 8: Change= 2	0 Participants	1 Participants	1 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 8: Change= 3	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 8: Change= 4	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 12: Change= -4	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 12: Change= -1	6 Participants	6 Participants	5 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 12: Change= 0	11 Participants	12 Participants	12 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 12: Change= 1	3 Participants	4 Participants	3 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 12: Change= 2	1 Participants	1 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 12: Change= 3	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 12: Change= 4	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 16: Change= -4	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 16: Change= -3	0 Participants	0 Participants	1 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 16: Change= -2	0 Participants	1 Participants	1 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 16: Change= -1	5 Participants	5 Participants	6 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 16: Change= 0	14 Participants	15 Participants	10 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 16: Change= 1	1 Participants	2 Participants	2 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 16: Change= 2	0 Participants	1 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 16: Change= 3	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 Week 16: Change= 4	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 1, 2, 4, 6, 8, 12, 16

Participants provided their response for patient's global evaluation of study medication by answering a question. Participants answered: "In all ways, how would you rate your overall response to the study medication today?" Participants responded using a 4-¬point likert scale where 1 = poor, 2 = fair, 3 = good and 4 = excellent. Higher score indicating better overall response to the treatment. Number of participants with each response level (poor, fair, good and excellent) were reported.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Tanezumab 50 mcg/kg n=33 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Tanezumab 200 mcg/kg n=32 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 1: Poor	11 Participants	13 Participants	13 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 1: Fair	5 Participants	5 Participants	8 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 1: Good	11 Participants	9 Participants	7 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 1: Excellent	2 Participants	3 Participants	1 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 2: Poor	7 Participants	12 Participants	13 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 2: Fair	6 Participants	4 Participants	9 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 2: Good	11 Participants	11 Participants	4 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 2: Excellent	3 Participants	2 Participants	1 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 4: Poor	7 Participants	7 Participants	7 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 4: Fair	9 Participants	11 Participants	14 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 4: Good	8 Participants	10 Participants	6 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 4: Excellent	2 Participants	1 Participants	2 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 6: Poor	7 Participants	8 Participants	7 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 6: Fair	8 Participants	9 Participants	7 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 6: Good	5 Participants	11 Participants	7 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 6: Excellent	2 Participants	0 Participants	5 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 8: Poor	4 Participants	9 Participants	10 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 8: Fair	4 Participants	9 Participants	5 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 8: Good	10 Participants	8 Participants	7 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 8: Excellent	2 Participants	2 Participants	4 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 12: Poor	7 Participants	8 Participants	10 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 12: Fair	6 Participants	8 Participants	5 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 12: Good	9 Participants	7 Participants	5 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 12: Excellent	0 Participants	2 Participants	4 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 16: Poor	3 Participants	6 Participants	6 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 16: Fair	7 Participants	8 Participants	6 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 16: Good	8 Participants	7 Participants	5 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 16: Excellent	3 Participants	4 Participants	4 Participants

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 4, 6, 8, 12, 16

Population: ITT population included all randomized participants who received Day 1 IV infusion (either tanezumab or placebo). Here, ''overall number of participants analyzed'' signifies number of participants evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at given time points.

mBPI-sf is a self-administered questionnaire (5 questions) to assess pain severity and impact of pain on daily functions. Questions (Q) 1-4 assess magnitude of pain severity (Q1 for worst, Q2 for least, Q3 for average, Q4 for pain right now) on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicate less pain. Question 5 consists of 7 item subsets which assess the level of interference of pain on daily functions: 1: general activity, 2: mood, 3: walking ability, 4: normal work, 5: relations with other, 6: sleep, 7: enjoyment of life. Each item was assessed on an 11-point NRS ranging from 0 (no interference) to 10 (complete interference), where lower scores indicated less interference of pain. Change from Baseline in mBPI-sf score for pain interference with sleep were reported.

Outcome measures

Outcome measures
Measure	Placebo n=30 Participants Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Tanezumab 50 mcg/kg n=32 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Tanezumab 200 mcg/kg n=29 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) Score for Pain Interference With Sleep at Weeks 1, 2, 4, 6, 8 ,12 and 16 Baseline	4.87 units on a scale Standard Deviation 3.06	4.66 units on a scale Standard Deviation 2.74	5.48 units on a scale Standard Deviation 2.59
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) Score for Pain Interference With Sleep at Weeks 1, 2, 4, 6, 8 ,12 and 16 Change at Week 1	-1.03 units on a scale Standard Deviation 3.34	-1.50 units on a scale Standard Deviation 2.20	-1.37 units on a scale Standard Deviation 3.21
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) Score for Pain Interference With Sleep at Weeks 1, 2, 4, 6, 8 ,12 and 16 Change at Week 2	-1.96 units on a scale Standard Deviation 2.68	-1.03 units on a scale Standard Deviation 2.78	-1.72 units on a scale Standard Deviation 3.81
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) Score for Pain Interference With Sleep at Weeks 1, 2, 4, 6, 8 ,12 and 16 Change at Week 4	-1.60 units on a scale Standard Deviation 2.66	-1.71 units on a scale Standard Deviation 2.19	-2.04 units on a scale Standard Deviation 3.13
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) Score for Pain Interference With Sleep at Weeks 1, 2, 4, 6, 8 ,12 and 16 Change at Week 6	-1.19 units on a scale Standard Deviation 1.72	-1.85 units on a scale Standard Deviation 2.23	-2.46 units on a scale Standard Deviation 3.40
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) Score for Pain Interference With Sleep at Weeks 1, 2, 4, 6, 8 ,12 and 16 Change at Week 8	-1.80 units on a scale Standard Deviation 1.88	-1.81 units on a scale Standard Deviation 2.69	-2.16 units on a scale Standard Deviation 3.41
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) Score for Pain Interference With Sleep at Weeks 1, 2, 4, 6, 8 ,12 and 16 Change at Week 12	-1.38 units on a scale Standard Deviation 1.96	-1.63 units on a scale Standard Deviation 2.83	-1.83 units on a scale Standard Deviation 4.25
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) Score for Pain Interference With Sleep at Weeks 1, 2, 4, 6, 8 ,12 and 16 Change at Week 16	-1.90 units on a scale Standard Deviation 1.52	-1.71 units on a scale Standard Deviation 3.22	-2.45 units on a scale Standard Deviation 3.72

SECONDARY outcome

Timeframe: Baseline up to Week 16

Population: ITT population included all randomized participants who received the Day 1 IV infusion (either tanezumab or placebo).

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Tanezumab 50 mcg/kg n=33 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Tanezumab 200 mcg/kg n=32 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Number of Participants Who Discontinued the Study Due to Lack of Efficacy	8 Participants	5 Participants	6 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 16

Population: ITT population included all randomized participants who received the Day 1 IV infusion (either tanezumab or placebo).

Time to discontinuation due to lack of efficacy was defined as the time interval from the date of study drug administration up to the date of discontinuation of participant from study due to lack of efficacy.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Tanezumab 50 mcg/kg n=33 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Tanezumab 200 mcg/kg n=32 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Time to Discontinuation Due to Lack of Efficacy	71.32 days Standard Error 4.95	40.79 days Standard Error 1.82	72.13 days Standard Error 3.91

SECONDARY outcome

Timeframe: Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16

In case of inadequate pain relief for post-herpetic neuralgia, acetaminophen up to 3000 mg per day up to 3 days in a week could be taken as rescue medication. Number of participants with any use of rescue medication during the specified study week were summarized.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Tanezumab 50 mcg/kg n=33 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Tanezumab 200 mcg/kg n=32 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Number of Participants Who Used Rescue Medications Week 1	18 Participants	22 Participants	12 Participants
Number of Participants Who Used Rescue Medications Week 2	16 Participants	17 Participants	14 Participants
Number of Participants Who Used Rescue Medications Week 3	15 Participants	17 Participants	17 Participants
Number of Participants Who Used Rescue Medications Week 4	10 Participants	18 Participants	13 Participants
Number of Participants Who Used Rescue Medications Week 5	11 Participants	16 Participants	10 Participants
Number of Participants Who Used Rescue Medications Week 6	12 Participants	15 Participants	15 Participants
Number of Participants Who Used Rescue Medications Week 7	10 Participants	13 Participants	13 Participants
Number of Participants Who Used Rescue Medications Week 8	7 Participants	17 Participants	11 Participants
Number of Participants Who Used Rescue Medications Week 9	6 Participants	15 Participants	12 Participants
Number of Participants Who Used Rescue Medications Week 10	9 Participants	14 Participants	13 Participants
Number of Participants Who Used Rescue Medications Week 11	9 Participants	15 Participants	11 Participants
Number of Participants Who Used Rescue Medications Week 12	10 Participants	17 Participants	11 Participants
Number of Participants Who Used Rescue Medications Week 13	8 Participants	15 Participants	9 Participants
Number of Participants Who Used Rescue Medications Week 14	10 Participants	15 Participants	8 Participants
Number of Participants Who Used Rescue Medications Week 15	8 Participants	12 Participants	12 Participants
Number of Participants Who Used Rescue Medications Week 16	6 Participants	14 Participants	13 Participants

SECONDARY outcome

Timeframe: Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16

In case of inadequate pain relief for post-herpetic neuralgia, acetaminophen up to 3000 mg per day up to 3 days in a week could be taken as rescue medication. Number of days participant used rescue medication, during the specified weeks were summarized.

Outcome measures

SECONDARY outcome

Timeframe: Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16

In case of inadequate pain relief for post-herpetic neuralgia, acetaminophen up to 3000 mg per day up to 3 days in a week could be taken as rescue medication. The total dosage of acetaminophen (in mg) used during the specified week were summarized.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Tanezumab 50 mcg/kg n=33 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Tanezumab 200 mcg/kg n=32 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Amount of Rescue Medication Taken Week 1	3677.4 milligram Standard Deviation 5348.8	3015.2 milligram Standard Deviation 4118.3	2125.0 milligram Standard Deviation 3535.5
Amount of Rescue Medication Taken Week 2	3419.4 milligram Standard Deviation 4949.9	3515.2 milligram Standard Deviation 4752.4	2467.7 milligram Standard Deviation 4106.8
Amount of Rescue Medication Taken Week 3	2661.3 milligram Standard Deviation 4772.1	2774.2 milligram Standard Deviation 4118.7	3100.0 milligram Standard Deviation 4810.9
Amount of Rescue Medication Taken Week 4	2851.9 milligram Standard Deviation 4598.9	2387.1 milligram Standard Deviation 3874.5	1733.3 milligram Standard Deviation 3109.3
Amount of Rescue Medication Taken Week 5	2500.0 milligram Standard Deviation 4759.6	1900.0 milligram Standard Deviation 3046.8	1883.3 milligram Standard Deviation 3600.0
Amount of Rescue Medication Taken Week 6	2960.0 milligram Standard Deviation 4964.3	1827.6 milligram Standard Deviation 3282.2	1810.3 milligram Standard Deviation 3100.7
Amount of Rescue Medication Taken Week 7	2920.0 milligram Standard Deviation 5217.5	1758.6 milligram Standard Deviation 3712.0	1689.7 milligram Standard Deviation 3137.9
Amount of Rescue Medication Taken Week 8	1770.8 milligram Standard Deviation 4175.4	2303.6 milligram Standard Deviation 3432.8	1517.9 milligram Standard Deviation 2447.5
Amount of Rescue Medication Taken Week 9	1760.9 milligram Standard Deviation 4504.7	2160.7 milligram Standard Deviation 3372.1	1517.9 milligram Standard Deviation 2488.8
Amount of Rescue Medication Taken Week 10	1847.8 milligram Standard Deviation 3767.2	2339.3 milligram Standard Deviation 3768.9	1759.3 milligram Standard Deviation 2693.9
Amount of Rescue Medication Taken Week 11	1891.3 milligram Standard Deviation 3394.4	2446.4 milligram Standard Deviation 3871.4	1666.7 milligram Standard Deviation 2609.2
Amount of Rescue Medication Taken Week 12	2326.1 milligram Standard Deviation 4193.1	2214.3 milligram Standard Deviation 3486.6	1961.5 milligram Standard Deviation 3168.4
Amount of Rescue Medication Taken Week 13	2590.9 milligram Standard Deviation 4371.5	2142.9 milligram Standard Deviation 3042.5	1400.0 milligram Standard Deviation 2594.1
Amount of Rescue Medication Taken Week 14	2285.7 milligram Standard Deviation 3477.0	1821.4 milligram Standard Deviation 2385.2	1160.0 milligram Standard Deviation 2330.6
Amount of Rescue Medication Taken Week 15	1595.2 milligram Standard Deviation 3084.7	2129.6 milligram Standard Deviation 3142.7	1854.2 milligram Standard Deviation 2826.4
Amount of Rescue Medication Taken Week 16	916.7 milligram Standard Deviation 1759.4	1870.4 milligram Standard Deviation 2475.2	2065.2 milligram Standard Deviation 3145.4

SECONDARY outcome

Timeframe: Baseline up to 112 days after the last dose of study drug (up to Week 16)

Population: Safety analysis population included all participants who received the day 1 IV infusion (either tanezumab or placebo infusion).

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 112 days after last dose (up to Week 16) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Tanezumab 50 mcg/kg n=33 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Tanezumab 200 mcg/kg n=32 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	20 Participants	24 Participants	21 Participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	1 Participants	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Screening visit (1 day prior to Day 1 baseline visit)

Population: Safety analysis population included all participants who received the day 1 IV infusion (either tanezumab or placebo infusion). Here, "number analyzed" signifies those participants who were evaluable for specified categories.

Physical examination included the examination of abdomen, ears, extremities, eyes, general appearance, head, heart, lungs, musculoskeletal assessment, neck, nose, skin, throat and thyroid. Abnormalities in physical examination was based on investigator's discretion.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Tanezumab 50 mcg/kg n=33 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Tanezumab 200 mcg/kg n=32 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Number of Participants With Abnormal Physical Examinations Findings at Screening Abdomen	0 Participants	3 Participants	1 Participants
Number of Participants With Abnormal Physical Examinations Findings at Screening Ear	0 Participants	1 Participants	2 Participants
Number of Participants With Abnormal Physical Examinations Findings at Screening Extremities	2 Participants	5 Participants	4 Participants
Number of Participants With Abnormal Physical Examinations Findings at Screening Eyes	1 Participants	4 Participants	0 Participants
Number of Participants With Abnormal Physical Examinations Findings at Screening General	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Physical Examinations Findings at Screening Head	2 Participants	0 Participants	3 Participants
Number of Participants With Abnormal Physical Examinations Findings at Screening Heart	1 Participants	3 Participants	1 Participants
Number of Participants With Abnormal Physical Examinations Findings at Screening Lungs	0 Participants	0 Participants	2 Participants
Number of Participants With Abnormal Physical Examinations Findings at Screening Musculoskeletal	1 Participants	3 Participants	4 Participants
Number of Participants With Abnormal Physical Examinations Findings at Screening Neck	0 Participants	2 Participants	1 Participants
Number of Participants With Abnormal Physical Examinations Findings at Screening Nose	1 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Physical Examinations Findings at Screening Skin	10 Participants	10 Participants	10 Participants
Number of Participants With Abnormal Physical Examinations Findings at Screening Throat	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Physical Examinations Findings at Screening Thyroid	0 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Safety analysis population included all participants who received the day 1 IV infusion (either tanezumab or placebo infusion). Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.

Physical examination included the examination of abdomen, ears, extremities, eyes, general appearance, head, heart, lungs, musculoskeletal assessment, neck, nose, skin, throat and thyroid.

Outcome measures

Outcome measures
Measure	Placebo n=30 Participants Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Tanezumab 50 mcg/kg n=32 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Tanezumab 200 mcg/kg n=31 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Number of Participants With Change From Baseline in Physical Examinations Findings at Week 16	1 Participants	3 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Week 16

Neurological examination included the assessment of cranial nerve function, coordination, reflexes, proprioception, mental status, motor function, gait and station and sensory function (sharp sensation, warm/cold sensation, light touch, deep pressure, and vibration sensation).

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Tanezumab 50 mcg/kg n=32 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Tanezumab 200 mcg/kg n=32 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Number of Participants With Change From Baseline in Neurological Examination Findings at Week 16	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Safety analysis population included all participants who received the day 1 IV infusion (either tanezumab or placebo infusion).

Vital signs included the assessment of the following: body temperature, blood pressure, heart rate and respiratory rate. Criteria for clinically significant vital signs included: heart rate value of less than (\<) 40 beats per minute and greater than (\>) 150 beats per minute, systolic blood pressure (SBP) of \<80 or \>210 millimeter of mercury (mmHg), diastolic blood pressure (DBP) of \<40 or \>130 mmHg, body temperature \<32 or \>40 degree centigrade, respiratory rate of \<10 or \>50 breaths/minute.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Tanezumab 50 mcg/kg n=33 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Tanezumab 200 mcg/kg n=32 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Week 16	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 16

Abnormality criteria: hematology (hemoglobin; hematocrit; red blood cell count \[less than {\<}0.8\* lower limit of normal \[LLN\], platelets \<0.5\* LLN,\>1.75\* upper limit of normal (ULN), white blood cell count\<0.6\* LLN, \>1.5\* ULN, liver function (total bilirubin\>1.5\* ULN, aspartate aminotransferase; alanine aminotransferase; gamma GT, LDH, alkaline phosphatase\>3.0\* ULN, total protein; albumin\<0.8\* LLN; \>1.2\* ULN), renal function (blood urea nitrogen; creatinine\>1.3\* ULN, uric acid\>1.2\* ULN), lipids (cholesterol, triglycerides \>1.3\*ULN), electrolytes (sodium \<0.95\* LLN, \>1.05\* ULN; potassium; chloride; calcium; magnesium; phosphate; bicarbonate\<0.9\* LLN, \>1.1\* ULN), chemistry (glucose \<0.6\*LLN, \>1.5\*ULN; creatine kinase \>2.0\*ULN), urinalysis (specific gravity \<1.003, \>1.030; pH\<4.5, \>8, glucose; protein; blood; ketones; urobilinogen; bilirubin; nitrite, esterase\>=1).

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Tanezumab 50 mcg/kg n=32 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Tanezumab 200 mcg/kg n=32 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Number of Participants With Laboratory Abnormalities	22 Participants	25 Participants	20 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 16

Criteria for abnormality in ECG parameters: Maximum corrected QT interval (QTc) in range of 450 to less than 480 millisecond (msec), Maximum QTcB interval (Bazett's Correction) (msec) in range of 450 to less than 480 msec, Maximum QTcF interval (Fridericia's Correction) in range of 450 to less than 480 msec, maximum QTc interval increase from baseline in range of 30 to less than 60 msec and \>=60 msec.

Outcome measures

Outcome measures
Measure	Placebo n=30 Participants Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Tanezumab 50 mcg/kg n=33 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Tanezumab 200 mcg/kg n=32 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Number of Participants With Electrocardiogram (ECG) Abnormalities	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 16

Population: Safety analysis population included all participants who received the day 1 IV infusion (either tanezumab or placebo infusion). Safety analysis population included all participants who received the day 1 IV infusion (either tanezumab or placebo infusion). Data for this outcome measure was not planned to be assessed collected and reported only for Tanezumab 50, 200 mcg/kg reporting group, not for placebo group.

Human serum ADA samples were analyzed for the presence or absence of anti--tanezumab antibodies by using a semi quantitative enzyme -linked immunosorbent assay (ELISA). Participants tested positive for ADA response on at least one post-baseline visit were reported. Participants with ADA titer level \>=4.32 for PF-04383119 were considered as ADA positive.

Outcome measures

Outcome measures
Measure	Placebo n=33 Participants Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Tanezumab 50 mcg/kg n=32 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Tanezumab 200 mcg/kg Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Number of Participants With Positive Anti-Drug Antibody (ADA) Response	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Baseline, Week 2, 6, 12, 16, end of study (i.e. anytime up to Week 16)

HVLT-R was a word-list learning and memory test used to assess the changes in memory. The task was repeated, for a total of 3 learning trials. After a delay interval of 20 to 25 minutes, delayed recall trial was administered. 1)Learning efficiency: Assessed by examining the learning curve over 3 learning trials and by evaluating the sum of the scores for all 3 learning trials. Raw scores for each of the 3 learning trials were summed for the total recall (TR) score. The TR score ranges from 0 to 36, where higher scores indicated greater verbal learning and recall, 2) Ability to access newly learned information: Assessed by the number of words retained on the delayed recall (DR) trial and the percentage of words recalled from the word list. DR trial score ranges from 0 to 12, where higher scores indicated greater verbal learning and recall.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Tanezumab 50 mcg/kg n=33 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Tanezumab 200 mcg/kg n=32 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study Baseline: TR	24.58 units on a scale Standard Deviation 3.59	23.15 units on a scale Standard Deviation 5.28	26.84 units on a scale Standard Deviation 5.54
Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study Change at Week 2: TR	-0.03 units on a scale Standard Deviation 4.31	0.19 units on a scale Standard Deviation 3.73	0.70 units on a scale Standard Deviation 4.20
Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study Change at Week 6: TR	1.50 units on a scale Standard Deviation 5.02	0.83 units on a scale Standard Deviation 4.29	1.08 units on a scale Standard Deviation 3.86
Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study Change at Week 12: TR	2.18 units on a scale Standard Deviation 3.92	1.35 units on a scale Standard Deviation 4.43	1.56 units on a scale Standard Deviation 3.85
Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study Change at Week 16: TR	3.10 units on a scale Standard Deviation 4.35	1.93 units on a scale Standard Deviation 4.58	2.61 units on a scale Standard Deviation 3.43
Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study End of Study: TR	3.03 units on a scale Standard Deviation 4.35	1.19 units on a scale Standard Deviation 4.71	2.37 units on a scale Standard Deviation 3.68
Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study Baseline: DR	9.16 units on a scale Standard Deviation 2.34	7.70 units on a scale Standard Deviation 2.48	9.47 units on a scale Standard Deviation 2.55
Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study Change at Week 2: DR	-0.20 units on a scale Standard Deviation 2.34	0.63 units on a scale Standard Deviation 1.96	0.67 units on a scale Standard Deviation 1.42
Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study Change at Week 6: DR	0.09 units on a scale Standard Deviation 1.97	0.86 units on a scale Standard Deviation 2.10	0.85 units on a scale Standard Deviation 1.62
Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study Change at Week 12: DR	0.50 units on a scale Standard Deviation 1.95	1.23 units on a scale Standard Deviation 2.29	0.56 units on a scale Standard Deviation 1.87
Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study Change at Week 16: DR	1.10 units on a scale Standard Deviation 2.43	1.81 units on a scale Standard Deviation 3.08	1.09 units on a scale Standard Deviation 1.98
Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study Change at End of study: DR	0.71 units on a scale Standard Deviation 2.55	1.69 units on a scale Standard Deviation 3.05	0.77 units on a scale Standard Deviation 1.92

SECONDARY outcome

Timeframe: Predose (0 hour) and 1, 2, 192, 193, 672, 673, 1008, 1009, 2016, 2017 and 2688 hours post dose on Day 1

Population: Pharmacokinetic (PK) analysis population included all participants who had at least 1 dose of study medication. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for placebo group.

AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).

Outcome measures

Outcome measures
Measure	Placebo n=26 Participants Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Tanezumab 50 mcg/kg n=26 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Tanezumab 200 mcg/kg Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) for Tanezumab	843814.9 nanogramhour per milliliter (nghr/mL) Standard Deviation 514324.95	2559793.7 nanogramhour per milliliter (nghr/mL) Standard Deviation 1332736.95	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Predose (0 hour) and 1, 2, 192, 193, 672, 673, 1008, 1009, 2016, 2017 and 2688 hours post dose on Day 1

Population: PK analysis population included all participants who had at least 1 dose of study medication. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for placebo group.

Area under the plasma concentration time-curve from time zero to the time of last measured concentration (AUClast).

Outcome measures

Outcome measures
Measure	Placebo n=32 Participants Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Tanezumab 50 mcg/kg n=30 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Tanezumab 200 mcg/kg Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Area Under the Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) for Tanezumab	873666.5 ng*hr/mL Standard Deviation 963283.79	2242378.0 ng*hr/mL Standard Deviation 1128330.22	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 1, 2688 hours postdose on Day 1

Plasma concentration of tanezumab at nominal collection time of 1 hour post-dose (C1) and plasma concentration at nominal collection time of 2688 hours post-dose (C2688) were reported.

Outcome measures

Outcome measures
Measure	Placebo n=33 Participants Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Tanezumab 50 mcg/kg n=32 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Tanezumab 200 mcg/kg Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Plasma Concentration of Tanezumab at Nominal Collection Time of 1 Hours and 2688 Hours Postdose C1	2101.8 nanogram per milliliter Standard Deviation 1765.97	6861.6 nanogram per milliliter Standard Deviation 4885.51	—
Plasma Concentration of Tanezumab at Nominal Collection Time of 1 Hours and 2688 Hours Postdose C2688	101.810 nanogram per milliliter Standard Deviation 325.241	170.984 nanogram per milliliter Standard Deviation 241.639	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Predose (0 hour) and 1, 2, 192, 193, 672, 673, 1008, 1009, 2016, 2017 and 2688 hours post dose on Day 1

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. It was calculated by dividing given intravenous dose by AUC inf. AUC inf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).

Outcome measures

Outcome measures
Measure	Placebo n=26 Participants Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Tanezumab 50 mcg/kg n=26 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Tanezumab 200 mcg/kg Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Total Clearance of Tanezumab From Plasma	0.082 milliliter per hour per kilogram Standard Deviation 0.053	0.093 milliliter per hour per kilogram Standard Deviation 0.042	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Predose (0 hour) and 1, 2, 192, 193, 672, 673, 1008, 1009, 2016, 2017 and 2688 hours post dose on Day 1

Terminal elimination half-life is the time measured for the plasma concentration of tanezumab to decrease by one half of its original concentration.

Outcome measures

Outcome measures
Measure	Placebo n=26 Participants Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Tanezumab 50 mcg/kg n=26 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Tanezumab 200 mcg/kg Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Terminal Elimination Half-Life (t1/2) of Tanezumab	18.92 days Standard Deviation 4.889	22.76 days Standard Deviation 7.336	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Predose (0 hour) and 1, 2, 192, 193, 672, 673, 1008, 1009, 2016, 2017 and 2688 hours post dose on Day 1

Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.

Outcome measures

Outcome measures
Measure	Placebo n=26 Participants Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Tanezumab 50 mcg/kg n=26 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Tanezumab 200 mcg/kg Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Volume of Distribution at Steady State (Vss) for Tanezumab	47.03 milliliter per kilogram Standard Deviation 22.334	65.96 milliliter per kilogram Standard Deviation 18.785	—

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

Tanezumab 50 mcg/kg

Serious events: 2 serious events

Other events: 24 other events

Deaths: 0 deaths

Tanezumab 200 mcg/kg

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=31 participants at risk Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Tanezumab 50 mcg/kg n=33 participants at risk Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Tanezumab 200 mcg/kg n=32 participants at risk Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Blood and lymphatic system disorders Anaemia	3.2% 1/31 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/33 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/32 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Cardiac disorders Myocardial infarction	0.00% 0/31 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	3.0% 1/33 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/32 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Gastrointestinal haemorrhage	3.2% 1/31 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/33 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/32 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Cellulitis	0.00% 0/31 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	3.0% 1/33 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/32 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/31 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/33 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	3.1% 1/32 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER

Measure	Placebo n=31 Participants Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Tanezumab 50 mcg/kg n=33 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Tanezumab 200 mcg/kg n=32 Participants Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Duration of Rescue Medication Use Week 1	1.00 days Interval 0.0 to 6.0	1.00 days Interval 0.0 to 6.0	0.00 days Interval 0.0 to 6.0
Duration of Rescue Medication Use Week 2	1.00 days Interval 0.0 to 7.0	1.00 days Interval 0.0 to 7.0	0.00 days Interval 0.0 to 7.0
Duration of Rescue Medication Use Week 3	0.00 days Interval 0.0 to 7.0	1.00 days Interval 0.0 to 7.0	1.50 days Interval 0.0 to 7.0
Duration of Rescue Medication Use Week 4	0.00 days Interval 0.0 to 7.0	1.00 days Interval 0.0 to 7.0	0.00 days Interval 0.0 to 7.0
Duration of Rescue Medication Use Week 5	0.00 days Interval 0.0 to 7.0	1.00 days Interval 0.0 to 7.0	0.00 days Interval 0.0 to 7.0
Duration of Rescue Medication Use Week 6	0.00 days Interval 0.0 to 7.0	1.00 days Interval 0.0 to 7.0	1.00 days Interval 0.0 to 7.0
Duration of Rescue Medication Use Week 7	0.00 days Interval 0.0 to 7.0	0.00 days Interval 0.0 to 7.0	0.00 days Interval 0.0 to 7.0
Duration of Rescue Medication Use Week 8	0.00 days Interval 0.0 to 7.0	1.00 days Interval 0.0 to 7.0	0.00 days Interval 0.0 to 7.0
Duration of Rescue Medication Use Week 9	0.00 days Interval 0.0 to 7.0	1.00 days Interval 0.0 to 7.0	0.00 days Interval 0.0 to 6.0
Duration of Rescue Medication Use Week 10	0.00 days Interval 0.0 to 7.0	0.50 days Interval 0.0 to 7.0	0.00 days Interval 0.0 to 6.0
Duration of Rescue Medication Use Week 11	0.00 days Interval 0.0 to 7.0	1.00 days Interval 0.0 to 7.0	0.00 days Interval 0.0 to 7.0
Duration of Rescue Medication Use Week 12	0.00 days Interval 0.0 to 7.0	1.00 days Interval 0.0 to 7.0	0.00 days Interval 0.0 to 7.0
Duration of Rescue Medication Use Week 13	0.00 days Interval 0.0 to 7.0	1.00 days Interval 0.0 to 7.0	0.00 days Interval 0.0 to 7.0
Duration of Rescue Medication Use Week 14	0.00 days Interval 0.0 to 7.0	1.00 days Interval 0.0 to 7.0	0.00 days Interval 0.0 to 7.0
Duration of Rescue Medication Use Week 15	0.00 days Interval 0.0 to 7.0	0.00 days Interval 0.0 to 7.0	0.50 days Interval 0.0 to 7.0
Duration of Rescue Medication Use Week 16	0.00 days Interval 0.0 to 7.0	1.00 days Interval 0.0 to 7.0	1.00 days Interval 0.0 to 7.0