Trial Outcomes & Findings for An Efficacy And Safety Study Of Tanezumab For The Treatment Of Pain Associated With Chronic Abacterial Prostatitis (NCT NCT00826514)

Last Updated: 2021-05-13

Results Overview

Participants assessed average chronic prostatitis pain in the last 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 (no chronic prostatitis pain) to 10 (chronic prostatitis pain as bad as you can imagine). The average daily pain score was calculated as the mean of the scores over the last 7 days prior to each assessment time point. Higher score indicated severe pain.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

62 participants

Primary outcome timeframe

Baseline, Week 6

Results posted on

2021-05-13

Participant Flow

Participant milestones

Participant milestones
Measure	Tanezumab A single dose of tanezumab (RN624 or PF-04383119) 20 milligram (mg) intravenous infusion over 5 minutes. Participants were followed up to Week 16.	Placebo A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes. Participants were followed up to Week 16.
Overall Study STARTED	30	32
Overall Study COMPLETED	27	27
Overall Study NOT COMPLETED	3	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Tanezumab A single dose of tanezumab (RN624 or PF-04383119) 20 milligram (mg) intravenous infusion over 5 minutes. Participants were followed up to Week 16.	Placebo A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes. Participants were followed up to Week 16.
Overall Study Adverse Event	1	1
Overall Study Lack of Efficacy	0	1
Overall Study Withdrawal by Subject	2	3

Baseline Characteristics

An Efficacy And Safety Study Of Tanezumab For The Treatment Of Pain Associated With Chronic Abacterial Prostatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tanezumab n=30 Participants A single dose of tanezumab (RN624 or PF-04383119) 20 milligram (mg) intravenous infusion over 5 minutes. Participants were followed up to Week 16.	Placebo n=32 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes. Participants were followed up to Week 16.	Total n=62 Participants Total of all reporting groups
Age, Customized 18 to 44 years	8 Participants n=93 Participants	18 Participants n=4 Participants	26 Participants n=27 Participants
Age, Customized 45 to 64 years	17 Participants n=93 Participants	12 Participants n=4 Participants	29 Participants n=27 Participants
Age, Customized Greater than or equal to (>=) 65 years	5 Participants n=93 Participants	2 Participants n=4 Participants	7 Participants n=27 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Male	30 Participants n=93 Participants	32 Participants n=4 Participants	62 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline, Week 6

Population: Restricted Full Analysis Set (rFAS): all randomized participants who received at least 1 treatment dose, completed at least 4 diary days during 7 day prior randomization, and had baseline, post-randomization primary efficacy data for 4 or more days within assessment window or for 2 or more consecutive days for diary endpoints derived from 3-day diary. Overall number of participants analyzed=participants evaluable for this measure; number analyzed=participants evaluable at specified timepoint.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes. Participants were followed up to Week 16.	Tanezumab n=30 Participants A single dose of tanezumab (RN624 or PF-04383119) 20 milligram (mg) intravenous infusion over 5 minutes. Participants were followed up to Week 16.
Change From Baseline in Average Daily Pain Score at Week 6 Baseline	5.6 units on a scale Standard Deviation 1.14	5.5 units on a scale Standard Deviation 1.10
Change From Baseline in Average Daily Pain Score at Week 6 Change at Week 6	-1.0 units on a scale Standard Deviation 1.43	-1.4 units on a scale Standard Deviation 1.43

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 10, and 16

Population: Analysis was performed on rFAS. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants who were evaluable at specified time point for each arm, respectively.

Outcome measures

Outcome measures
Measure	Placebo n=30 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes. Participants were followed up to Week 16.	Tanezumab n=30 Participants A single dose of tanezumab (RN624 or PF-04383119) 20 milligram (mg) intravenous infusion over 5 minutes. Participants were followed up to Week 16.
Change From Baseline in Average Daily Pain Score at Weeks 2, 4, 8, 10, and 16 Change at Week 2	-1.1 units on a scale Standard Deviation 1.13	-0.8 units on a scale Standard Deviation 1.43
Change From Baseline in Average Daily Pain Score at Weeks 2, 4, 8, 10, and 16 Change at Week 4	-0.9 units on a scale Standard Deviation 1.37	-1.6 units on a scale Standard Deviation 1.51
Change From Baseline in Average Daily Pain Score at Weeks 2, 4, 8, 10, and 16 Change at Week 8	-1.3 units on a scale Standard Deviation 1.61	-1.5 units on a scale Standard Deviation 1.46
Change From Baseline in Average Daily Pain Score at Weeks 2, 4, 8, 10, and 16 Change at Week 10	-1.4 units on a scale Standard Deviation 1.58	-1.5 units on a scale Standard Deviation 1.62
Change From Baseline in Average Daily Pain Score at Weeks 2, 4, 8, 10, and 16 Change at Week 16	-1.9 units on a scale Standard Deviation 1.47	-1.8 units on a scale Standard Deviation 1.30

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 6, 8, 10, and 16

Population: Analysis was performed on rFAS. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' evaluable participants at specified time point for each arm, respectively.

Participants assessed worst chronic prostatitis pain in the last 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 (no chronic prostatitis pain) to 10 (chronic prostatitis pain as bad as you can imagine). The worst daily pain score was calculated as the mean of the scores over the last 7 days prior to each assessment time point. Higher score indicated severe pain.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes. Participants were followed up to Week 16.	Tanezumab n=30 Participants A single dose of tanezumab (RN624 or PF-04383119) 20 milligram (mg) intravenous infusion over 5 minutes. Participants were followed up to Week 16.
Change From Baseline in Worst Daily Pain Score at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 2	-1.2 units on a scale Standard Deviation 1.31	-0.7 units on a scale Standard Deviation 1.75
Change From Baseline in Worst Daily Pain Score at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 4	-0.9 units on a scale Standard Deviation 1.55	-1.6 units on a scale Standard Deviation 1.85
Change From Baseline in Worst Daily Pain Score at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 6	-1.1 units on a scale Standard Deviation 1.43	-1.4 units on a scale Standard Deviation 1.95
Change From Baseline in Worst Daily Pain Score at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 10	-1.7 units on a scale Standard Deviation 1.82	-1.4 units on a scale Standard Deviation 2.01
Change From Baseline in Worst Daily Pain Score at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 16	-2.1 units on a scale Standard Deviation 1.62	-1.8 units on a scale Standard Deviation 1.79
Change From Baseline in Worst Daily Pain Score at Weeks 2, 4, 6, 8, 10, and 16 Baseline	6.8 units on a scale Standard Deviation 1.12	6.4 units on a scale Standard Deviation 1.17
Change From Baseline in Worst Daily Pain Score at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 8	-1.4 units on a scale Standard Deviation 1.86	-1.3 units on a scale Standard Deviation 2.01

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 6, 8, 10, and 16

Population: Analysis was performed on rFAS. Here, 'number analyzed' signifies evaluable participants at specified time point for each arm, respectively.

CPSI is a 9-item questionnaire, contains 3 modules that measure pain (question 1 to 4), urinary symptoms (question 5 and 6) and global quality of life (question 7 to 9). Total scores range from 0 to 21 on the pain module, 0 to 10 on the urinary symptoms and 0 to 12 on the quality of life module. NIH-CPSI total score (9-items) range from 0 to 43. Higher total and module scores indicate greater symptom severity and bother.

Outcome measures

Outcome measures
Measure	Placebo n=32 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes. Participants were followed up to Week 16.	Tanezumab n=30 Participants A single dose of tanezumab (RN624 or PF-04383119) 20 milligram (mg) intravenous infusion over 5 minutes. Participants were followed up to Week 16.
Change From Baseline in National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Overall and Sub-scale Score at Weeks 2, 4, 6, 8, 10, and 16 Baseline: CPSI Urinary Symptom (US) Score	4.1 units on a scale Standard Deviation 2.88	4.2 units on a scale Standard Deviation 2.39
Change From Baseline in National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Overall and Sub-scale Score at Weeks 2, 4, 6, 8, 10, and 16 Baseline: CPSI Pain Domain (PD) Score	13.5 units on a scale Standard Deviation 1.85	13.0 units on a scale Standard Deviation 2.09
Change From Baseline in National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Overall and Sub-scale Score at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 16: CPSI PD Score	-3.2 units on a scale Standard Deviation 3.93	-2.4 units on a scale Standard Deviation 3.06
Change From Baseline in National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Overall and Sub-scale Score at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 6: CPSI PD Score	-2.2 units on a scale Standard Deviation 2.94	-2.8 units on a scale Standard Deviation 3.64
Change From Baseline in National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Overall and Sub-scale Score at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 6: CPSI US Score	-0.8 units on a scale Standard Deviation 3.18	-0.2 units on a scale Standard Deviation 2.38
Change From Baseline in National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Overall and Sub-scale Score at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 6: CPSI QoL Score	-1.0 units on a scale Standard Deviation 2.32	-1.3 units on a scale Standard Deviation 2.67
Change From Baseline in National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Overall and Sub-scale Score at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 8: CPSI Total Score	-4.8 units on a scale Standard Deviation 7.55	-3.0 units on a scale Standard Deviation 5.73
Change From Baseline in National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Overall and Sub-scale Score at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 8: CPSI PD Score	-2.9 units on a scale Standard Deviation 3.97	-2.1 units on a scale Standard Deviation 3.15
Change From Baseline in National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Overall and Sub-scale Score at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 8: CPSI US Score	-0.5 units on a scale Standard Deviation 2.65	-0.0 units on a scale Standard Deviation 1.72
Change From Baseline in National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Overall and Sub-scale Score at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 8: CPSI QoL Score	-1.4 units on a scale Standard Deviation 2.48	-0.8 units on a scale Standard Deviation 2.36
Change From Baseline in National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Overall and Sub-scale Score at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 10: CPSI Total Score	-4.9 units on a scale Standard Deviation 7.62	-2.9 units on a scale Standard Deviation 6.06
Change From Baseline in National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Overall and Sub-scale Score at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 10: CPSI PD Score	-3.0 units on a scale Standard Deviation 3.64	-2.4 units on a scale Standard Deviation 3.56
Change From Baseline in National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Overall and Sub-scale Score at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 10: CPSI US Score	-0.7 units on a scale Standard Deviation 2.59	0.6 units on a scale Standard Deviation 1.96
Change From Baseline in National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Overall and Sub-scale Score at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 10: CPSI QoL Score	-1.2 units on a scale Standard Deviation 2.87	-1.1 units on a scale Standard Deviation 2.20
Change From Baseline in National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Overall and Sub-scale Score at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 16: CPSI Total Score	-5.3 units on a scale Standard Deviation 7.62	-4.0 units on a scale Standard Deviation 6.34
Change From Baseline in National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Overall and Sub-scale Score at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 16: CPSI US Score	-0.5 units on a scale Standard Deviation 2.76	-0.3 units on a scale Standard Deviation 2.08
Change From Baseline in National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Overall and Sub-scale Score at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 16: CPSI QoL Score	-1.6 units on a scale Standard Deviation 2.59	-1.2 units on a scale Standard Deviation 2.35
Change From Baseline in National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Overall and Sub-scale Score at Weeks 2, 4, 6, 8, 10, and 16 Baseline: CPSI Quality of Life (QoL) Score	8.8 units on a scale Standard Deviation 1.87	8.3 units on a scale Standard Deviation 2.18
Change From Baseline in National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Overall and Sub-scale Score at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 2: CPSI Total Score	-3.1 units on a scale Standard Deviation 5.92	-3.2 units on a scale Standard Deviation 6.72
Change From Baseline in National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Overall and Sub-scale Score at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 2: CPSI PD Score	-1.8 units on a scale Standard Deviation 2.78	-2.3 units on a scale Standard Deviation 3.44
Change From Baseline in National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Overall and Sub-scale Score at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 2: CPSI US Score	-0.3 units on a scale Standard Deviation 2.29	0.2 units on a scale Standard Deviation 2.25
Change From Baseline in National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Overall and Sub-scale Score at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 2: CPSI QoL Score	-1.0 units on a scale Standard Deviation 1.69	-1.0 units on a scale Standard Deviation 2.47
Change From Baseline in National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Overall and Sub-scale Score at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 4: CPSI Total Score	-3.5 units on a scale Standard Deviation 6.27	-5.2 units on a scale Standard Deviation 6.56
Change From Baseline in National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Overall and Sub-scale Score at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 4: CPSI PD Score	-2.0 units on a scale Standard Deviation 2.72	-3.5 units on a scale Standard Deviation 3.63
Change From Baseline in National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Overall and Sub-scale Score at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 4: CPSI US Score	-0.7 units on a scale Standard Deviation 2.80	0.1 units on a scale Standard Deviation 2.44
Change From Baseline in National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Overall and Sub-scale Score at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 4: CPSI QoL Score	-0.9 units on a scale Standard Deviation 1.96	-1.8 units on a scale Standard Deviation 2.71
Change From Baseline in National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Overall and Sub-scale Score at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 6: CPSI Total Score	-4.0 units on a scale Standard Deviation 7.06	-4.3 units on a scale Standard Deviation 7.04
Change From Baseline in National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Overall and Sub-scale Score at Weeks 2, 4, 6, 8, 10, and 16 Baseline: CPSI Total Score	26.4 units on a scale Standard Deviation 4.38	25.5 units on a scale Standard Deviation 4.91

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 8, 10, and 16

The micturition frequency per 24 hours was calculated from the sum of voluntary voids divided by the diary period over which they were collected.

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes. Participants were followed up to Week 16.	Tanezumab n=24 Participants A single dose of tanezumab (RN624 or PF-04383119) 20 milligram (mg) intravenous infusion over 5 minutes. Participants were followed up to Week 16.
Change From Baseline in Number of Micturitions Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 Baseline	9.4 micturitions per 24 hours Standard Deviation 4.75	9.1 micturitions per 24 hours Standard Deviation 3.70
Change From Baseline in Number of Micturitions Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 2	-0.3 micturitions per 24 hours Standard Deviation 3.32	0.9 micturitions per 24 hours Standard Deviation 2.86
Change From Baseline in Number of Micturitions Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 4	-0.6 micturitions per 24 hours Standard Deviation 4.10	0.3 micturitions per 24 hours Standard Deviation 2.45
Change From Baseline in Number of Micturitions Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 6	-0.3 micturitions per 24 hours Standard Deviation 3.54	0.3 micturitions per 24 hours Standard Deviation 1.92
Change From Baseline in Number of Micturitions Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 8	-0.7 micturitions per 24 hours Standard Deviation 4.69	0.6 micturitions per 24 hours Standard Deviation 3.50
Change From Baseline in Number of Micturitions Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 10	-1.2 micturitions per 24 hours Standard Deviation 3.76	1.0 micturitions per 24 hours Standard Deviation 2.92
Change From Baseline in Number of Micturitions Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 16	-0.8 micturitions per 24 hours Standard Deviation 4.25	0.3 micturitions per 24 hours Standard Deviation 1.96

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 6, 8, 10, and 16

Population: Analysis was performed on rFAS. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number anlayzed' signifies those participants who were evaluable at specified time point for each arm, respectively.

Nocturnal micturition was calculated as the sum of voluntary voids that occur during a night's sleep, divided by the number of nights over which this was collected.

Outcome measures

Outcome measures
Measure	Placebo n=25 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes. Participants were followed up to Week 16.	Tanezumab n=24 Participants A single dose of tanezumab (RN624 or PF-04383119) 20 milligram (mg) intravenous infusion over 5 minutes. Participants were followed up to Week 16.
Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 Baseline	3.8 micturitions per 24 hours Standard Deviation 3.56	3.0 micturitions per 24 hours Standard Deviation 3.24
Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 2	-1.2 micturitions per 24 hours Standard Deviation 3.43	-0.2 micturitions per 24 hours Standard Deviation 2.45
Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 4	-1.2 micturitions per 24 hours Standard Deviation 2.65	-0.6 micturitions per 24 hours Standard Deviation 3.09
Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 6	-0.8 micturitions per 24 hours Standard Deviation 3.91	-0.4 micturitions per 24 hours Standard Deviation 3.45
Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 8	0.4 micturitions per 24 hours Standard Deviation 3.30	0.9 micturitions per 24 hours Standard Deviation 3.39
Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 10	-0.6 micturitions per 24 hours Standard Deviation 3.39	-1.0 micturitions per 24 hours Standard Deviation 2.77
Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 16	-1.4 micturitions per 24 hours Standard Deviation 3.89	-0.8 micturitions per 24 hours Standard Deviation 1.48

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 6, 8, 10, and 16

Mean voided volume per micturition was calculated as the total urine volume voided (resulting from a toilet \[voluntary\] void) during the diary period when this was measured, divided by the number of toilet voids over which this occurred.

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes. Participants were followed up to Week 16.	Tanezumab n=24 Participants A single dose of tanezumab (RN624 or PF-04383119) 20 milligram (mg) intravenous infusion over 5 minutes. Participants were followed up to Week 16.
Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 6	8.3 milliliter Standard Deviation 68.48	-24.7 milliliter Standard Deviation 58.94
Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 6, 8, 10, and 16 Baseline	208.5 milliliter Standard Deviation 86.38	216.7 milliliter Standard Deviation 90.04
Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 2	26.8 milliliter Standard Deviation 66.13	-13.8 milliliter Standard Deviation 47.95
Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 4	12.1 milliliter Standard Deviation 62.80	-17.4 milliliter Standard Deviation 46.49
Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 8	11.0 milliliter Standard Deviation 68.07	-7.4 milliliter Standard Deviation 48.11
Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 10	20.3 milliliter Standard Deviation 74.81	-27.5 milliliter Standard Deviation 63.45
Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 16	15.0 milliliter Standard Deviation 67.92	-27.4 milliliter Standard Deviation 48.32

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 6, 8, 10, and 16

Subject assessed discrete urinary events: voluntary toilet voids (with volume voided), and urgency episodes. For each urinary event, subjects assessed the level of pain intensity on a 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Mean pain severity per urinary event (toilet void, urgency episode) was calculated as the mean of all pain severities over the last 7 days prior to each assessment time point. Higher score indicated severe pain.

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes. Participants were followed up to Week 16.	Tanezumab n=24 Participants A single dose of tanezumab (RN624 or PF-04383119) 20 milligram (mg) intravenous infusion over 5 minutes. Participants were followed up to Week 16.
Change From Baseline in Mean Urinary Event Pain Score Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 16	-0.8 units on a scale Standard Deviation 2.04	-0.7 units on a scale Standard Deviation 1.34
Change From Baseline in Mean Urinary Event Pain Score Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 Baseline	3.6 units on a scale Standard Deviation 1.99	3.0 units on a scale Standard Deviation 2.37
Change From Baseline in Mean Urinary Event Pain Score Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 2	-0.4 units on a scale Standard Deviation 1.29	-0.2 units on a scale Standard Deviation 1.39
Change From Baseline in Mean Urinary Event Pain Score Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 4	-0.5 units on a scale Standard Deviation 1.55	-0.7 units on a scale Standard Deviation 1.41
Change From Baseline in Mean Urinary Event Pain Score Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 6	-0.3 units on a scale Standard Deviation 2.03	-0.6 units on a scale Standard Deviation 1.37
Change From Baseline in Mean Urinary Event Pain Score Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 8	-0.6 units on a scale Standard Deviation 1.88	-0.7 units on a scale Standard Deviation 1.49
Change From Baseline in Mean Urinary Event Pain Score Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 10	-1.0 units on a scale Standard Deviation 1.59	-0.6 units on a scale Standard Deviation 1.32

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 6, 8, 10, and 16

Urinary urgency episodes per 24 hours was calculated as the sum of any urgency episodes occurring during the diary period when this was measured, divided by the number of days over which they were recorded.

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes. Participants were followed up to Week 16.	Tanezumab n=24 Participants A single dose of tanezumab (RN624 or PF-04383119) 20 milligram (mg) intravenous infusion over 5 minutes. Participants were followed up to Week 16.
Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 8	0.6 urgency episodes per 24 hours Standard Deviation 5.86	0.3 urgency episodes per 24 hours Standard Deviation 3.59
Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 Baseline	5.1 urgency episodes per 24 hours Standard Deviation 5.50	4.7 urgency episodes per 24 hours Standard Deviation 5.65
Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 2	-0.3 urgency episodes per 24 hours Standard Deviation 4.08	0.3 urgency episodes per 24 hours Standard Deviation 3.14
Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 4	0.2 urgency episodes per 24 hours Standard Deviation 5.10	-0.9 urgency episodes per 24 hours Standard Deviation 3.03
Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 6	0.0 urgency episodes per 24 hours Standard Deviation 4.90	-0.8 urgency episodes per 24 hours Standard Deviation 1.44
Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 10	-0.7 urgency episodes per 24 hours Standard Deviation 5.67	-0.1 urgency episodes per 24 hours Standard Deviation 3.58
Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 16	-0.6 urgency episodes per 24 hours Standard Deviation 5.35	-1.4 urgency episodes per 24 hours Standard Deviation 2.25

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 6, 8, 10, and 16

Population: Analysis was performed on rFAS. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this measure and number analyzed' signifies those participants who were evaluable at specified time point for each arm, respectively.

Mean sleep disturbance score was calculated from the sleep disturbance experienced over the previous night. The average sleep disturbance score per night was determined from calculating an average of all sleep disturbance scores in the 7 days prior to each assessment time point. Participants answered: "Over the past 24 hours, how much did the symptoms that you associate with your chronic prostatitis disturb your sleep?" Participants responded on a 5-points rating scale, ranged from 0 = not at all, 1 = a little, 2 = somewhat, 3 = very, and 4 = extremely. Higher score indicated greater sleep disturbance.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes. Participants were followed up to Week 16.	Tanezumab n=30 Participants A single dose of tanezumab (RN624 or PF-04383119) 20 milligram (mg) intravenous infusion over 5 minutes. Participants were followed up to Week 16.
Change From Baseline in Mean Sleep Disturbance Score Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 16	-0.4 units on a scale Standard Deviation 0.84	-0.4 units on a scale Standard Deviation 0.81
Change From Baseline in Mean Sleep Disturbance Score Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 Baseline	1.7 units on a scale Standard Deviation 1.00	1.9 units on a scale Standard Deviation 0.80
Change From Baseline in Mean Sleep Disturbance Score Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 2	-0.4 units on a scale Standard Deviation 0.54	-0.3 units on a scale Standard Deviation 0.93
Change From Baseline in Mean Sleep Disturbance Score Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 4	-0.3 units on a scale Standard Deviation 0.74	-0.5 units on a scale Standard Deviation 0.79
Change From Baseline in Mean Sleep Disturbance Score Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 6	-0.3 units on a scale Standard Deviation 0.75	-0.4 units on a scale Standard Deviation 0.88
Change From Baseline in Mean Sleep Disturbance Score Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 8	-0.4 units on a scale Standard Deviation 0.79	-0.4 units on a scale Standard Deviation 0.91
Change From Baseline in Mean Sleep Disturbance Score Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 10	-0.3 units on a scale Standard Deviation 0.82	-0.4 units on a scale Standard Deviation 0.93

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 6, 8, 10, and 16

The participants were first asked whether they had ejaculated during the past 24 hours. If yes, they recorded how much pain related to ejaculation they had experienced during the past 24 hours by choosing the appropriate number an 11-point numeric rating scale (NRS) ranging from 0 (no ejaculatory pain at all) to 10 (ejaculatory pain as bad as you can imagine). Higher score indicated greater pain. Mean pain score associated with ejaculation was calculated from all ejaculation pain scores recorded in the 7 days prior to each assessment time point.

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes. Participants were followed up to Week 16.	Tanezumab n=17 Participants A single dose of tanezumab (RN624 or PF-04383119) 20 milligram (mg) intravenous infusion over 5 minutes. Participants were followed up to Week 16.
Change From Baseline in Mean Pain Score Associated With Ejaculation Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 2	-0.9 units on a scale Standard Deviation 1.37	0.3 units on a scale Standard Deviation 2.47
Change From Baseline in Mean Pain Score Associated With Ejaculation Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 Baseline	3.4 units on a scale Standard Deviation 2.50	3.8 units on a scale Standard Deviation 2.40
Change From Baseline in Mean Pain Score Associated With Ejaculation Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 4	-0.3 units on a scale Standard Deviation 1.87	-1.3 units on a scale Standard Deviation 1.30
Change From Baseline in Mean Pain Score Associated With Ejaculation Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 6	-0.5 units on a scale Standard Deviation 1.69	-1.5 units on a scale Standard Deviation 2.01
Change From Baseline in Mean Pain Score Associated With Ejaculation Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 8	-0.4 units on a scale Standard Deviation 1.59	-0.4 units on a scale Standard Deviation 1.94
Change From Baseline in Mean Pain Score Associated With Ejaculation Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 10	-0.7 units on a scale Standard Deviation 1.68	-1.0 units on a scale Standard Deviation 2.25
Change From Baseline in Mean Pain Score Associated With Ejaculation Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 Change at Week 16	-1.6 units on a scale Standard Deviation 1.64	-1.3 units on a scale Standard Deviation 1.76

SECONDARY outcome

Timeframe: Week 6 and 16

Population: Analysis was performed on rFAS. Here, 'overall number of participants analyzed) signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants who were evaluable at specified time point for each arm, respectively.

The GRA questionnaire is a 7-point symmetric scale, which measured patient-reported overall response to treatment compared to baseline with the following possible responses: 1= markedly worse, 2 = moderately worse, 3= slightly worse, 4= no change, 5 = slightly improved,6 = moderately improved, and 7 = markedly improved. Participants who reported either of the latter 2 categories were defined as treatment responders. Participants were asked "Compared to when you began this trial, how would you rate your chronic prostatitis symptoms now?". Participants responded on 7-point symmetric scale ranged 1 to 7, where higher score indicated improvement.

Outcome measures

Outcome measures
Measure	Placebo n=26 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes. Participants were followed up to Week 16.	Tanezumab n=25 Participants A single dose of tanezumab (RN624 or PF-04383119) 20 milligram (mg) intravenous infusion over 5 minutes. Participants were followed up to Week 16.
Number of Participants With Global Response Assessment (GRA) Week 6: Slightly Worse	0 Participants	1 Participants
Number of Participants With Global Response Assessment (GRA) Week 6: No Change	11 Participants	6 Participants
Number of Participants With Global Response Assessment (GRA) Week 6: Moderately Improved	5 Participants	3 Participants
Number of Participants With Global Response Assessment (GRA) Week 16: Moderately Improved	6 Participants	4 Participants
Number of Participants With Global Response Assessment (GRA) Week 16: Markedly Improved	1 Participants	1 Participants
Number of Participants With Global Response Assessment (GRA) Week 16: No Change	8 Participants	9 Participants
Number of Participants With Global Response Assessment (GRA) Week 16: Slightly Improved	6 Participants	8 Participants
Number of Participants With Global Response Assessment (GRA) Week 6: Markedly Worse	1 Participants	0 Participants
Number of Participants With Global Response Assessment (GRA) Week 6: Moderately Worse	1 Participants	2 Participants
Number of Participants With Global Response Assessment (GRA) Week 6: Slightly Improved	7 Participants	10 Participants
Number of Participants With Global Response Assessment (GRA) Week 6: Markedly Improved	1 Participants	3 Participants
Number of Participants With Global Response Assessment (GRA) Week 16: Markedly Worse	0 Participants	0 Participants
Number of Participants With Global Response Assessment (GRA) Week 16: Moderately Worse	0 Participants	0 Participants
Number of Participants With Global Response Assessment (GRA) Week 16: Slightly Worse	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Week 6 and 16

Participant global satisfaction was assessed using Patient Reported Treatment Impact (PRTI) which was a self-administered questionnaire containing four items to assess participant satisfaction, previous treatment, preference and willingness to continue using the study medication. Participant's answered the question "Overall, how satisfied are you with the drug that you received since you entered this trial?". Participants provided response on a 5-point scale where 1=extremely dissatisfied, 2=dissatisfied, 3=neither satisfied nor dissatisfied, 4=satisfied and 5=extremely satisfied. Higher score indicated greater satisfaction, preference or willingness to use study medication. Number of participants with each response is reported.

Outcome measures

Outcome measures
Measure	Placebo n=24 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes. Participants were followed up to Week 16.	Tanezumab n=25 Participants A single dose of tanezumab (RN624 or PF-04383119) 20 milligram (mg) intravenous infusion over 5 minutes. Participants were followed up to Week 16.
Patient Global Satisfaction Assessment Week 6: Extremely Satisfied	0 Participants	3 Participants
Patient Global Satisfaction Assessment Week 6: Satisfied	5 Participants	5 Participants
Patient Global Satisfaction Assessment Week 6:Neither Satisfied nor Dissatisfied	13 Participants	10 Participants
Patient Global Satisfaction Assessment Week 16: Dissatisfied	1 Participants	5 Participants
Patient Global Satisfaction Assessment Week 6: Dissatisfied	3 Participants	5 Participants
Patient Global Satisfaction Assessment Week 6: Extremely Dissatisfied	3 Participants	2 Participants
Patient Global Satisfaction Assessment Week 16: Extremely Satisfied	1 Participants	4 Participants
Patient Global Satisfaction Assessment Week16:Neither Satisfied nor Dissatisfied	7 Participants	5 Participants
Patient Global Satisfaction Assessment Week 16: Satisfied	11 Participants	7 Participants
Patient Global Satisfaction Assessment Week 16: Extremely Dissatisfied	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Week 6 and 16

Population: Analysis was performed on rFAS. Here, ''overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants who were evaluable at specified time point for each arm, respectively.

Participant global preference is assessed using PRTI which is a self-administered questionnaire containing four items to assess participant satisfaction, previous treatment, preference and willingness to continue using the study medication. Participant reported previous treatment under following categories: lifestyle interventions, physical therapies, training programs, drug treatment - taken by mouth, surgery or other prostate procedure (e.g, microwave treatment), and no treatment. Participant preference was assessed using following categories: definitely prefer study medication, slightly prefer study medication, no preference, slightly prefer previous treatment, and definitely prefer previous treatment. Number of participants under each of the categories is reported. For previous treatment, a single participant may be represented in more than 1 category.

Outcome measures

Outcome measures
Measure	Placebo n=24 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes. Participants were followed up to Week 16.	Tanezumab n=25 Participants A single dose of tanezumab (RN624 or PF-04383119) 20 milligram (mg) intravenous infusion over 5 minutes. Participants were followed up to Week 16.
Participant Global Preference Week 6: No Treatment	4 Participants	6 Participants
Participant Global Preference Week 6: Definitely Prefer Current Drug	5 Participants	4 Participants
Participant Global Preference Week 6: Slight Preference for Current Drug	5 Participants	7 Participants
Participant Global Preference Week 6: No Preference	12 Participants	13 Participants
Participant Global Preference Week 6: Slight Preference, Prior Treatment	0 Participants	0 Participants
Participant Global Preference Week 16: Lifestyle Interventions	7 Participants	7 Participants
Participant Global Preference Week 16: Drug treatment-taken by mouth	18 Participants	17 Participants
Participant Global Preference Week 16: No Treatment	1 Participants	3 Participants
Participant Global Preference Week 16: Definitely Prefer Prior Treatment	3 Participants	2 Participants
Participant Global Preference Week 6: Lifestyle Interventions	5 Participants	5 Participants
Participant Global Preference Week 6: Physical Therapies	4 Participants	2 Participants
Participant Global Preference Week 6:Drug treatment-taken by mouth	14 Participants	19 Participants
Participant Global Preference Week 6: Surgery/other prostate procedure	2 Participants	0 Participants
Participant Global Preference Week 6: Training Programs	0 Participants	2 Participants
Participant Global Preference Week 6: Definitely Prefer Prior Treatment	2 Participants	1 Participants
Participant Global Preference Week 16: Physical Therapies	4 Participants	3 Participants
Participant Global Preference Week 16: Training Programs	3 Participants	3 Participants
Participant Global Preference Week 16: Surgery/other prostate procedure	0 Participants	1 Participants
Participant Global Preference Week 16: Definitely Prefer Current Drug	8 Participants	9 Participants
Participant Global Preference Week 16: Slight Preference for Current Drug	5 Participants	4 Participants
Participant Global Preference Week 16: No Preference	6 Participants	8 Participants
Participant Global Preference Week 16: Slight Preference, Prior Treatment	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 6 and 16

Participant willingness to re-use study medication was assessed using PRTI which is a self-administered questionnaire containing four items to assess participant satisfaction, previous treatment, preference and willingness to continue using the study medication. Participant willingness to re-use study medication was assessed using following categories: definitely want to re-use, might want to re-use, not sure, might not want to re-use, definitely would not want to re-use.

Outcome measures

Outcome measures
Measure	Placebo n=24 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes. Participants were followed up to Week 16.	Tanezumab n=25 Participants A single dose of tanezumab (RN624 or PF-04383119) 20 milligram (mg) intravenous infusion over 5 minutes. Participants were followed up to Week 16.
Patient Willingness to Re-use Medicine Week 6: Definitely Want	8 Participants	6 Participants
Patient Willingness to Re-use Medicine Week 6: Might Want	4 Participants	6 Participants
Patient Willingness to Re-use Medicine Week 6: Might not Want	0 Participants	2 Participants
Patient Willingness to Re-use Medicine Week 6: Definitely Would not Want	3 Participants	3 Participants
Patient Willingness to Re-use Medicine Week 16: Not Sure	1 Participants	4 Participants
Patient Willingness to Re-use Medicine Week 16: Might not Want	0 Participants	3 Participants
Patient Willingness to Re-use Medicine Week 6: Not Sure	9 Participants	8 Participants
Patient Willingness to Re-use Medicine Week 16: Definitely Want	11 Participants	10 Participants
Patient Willingness to Re-use Medicine Week 16: Might Want	7 Participants	3 Participants
Patient Willingness to Re-use Medicine Week 16: Definitely Would not Want	3 Participants	3 Participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 6, 8, 10, and 16

In the event of inadequate pain relief or worsening symptoms of chronic prostatitis, participants were allowed to take acetaminophen/paracetamol 500 mg, tablets or capsules as rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=32 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes. Participants were followed up to Week 16.	Tanezumab n=30 Participants A single dose of tanezumab (RN624 or PF-04383119) 20 milligram (mg) intravenous infusion over 5 minutes. Participants were followed up to Week 16.
Percentage of Participants Who Received Rescue Medication Week 2	19 percentage of participants	22 percentage of participants
Percentage of Participants Who Received Rescue Medication Week 4	17 percentage of participants	17 percentage of participants
Percentage of Participants Who Received Rescue Medication Week 8	12 percentage of participants	14 percentage of participants
Percentage of Participants Who Received Rescue Medication Week 10	11 percentage of participants	13 percentage of participants
Percentage of Participants Who Received Rescue Medication Week 16	4 percentage of participants	12 percentage of participants
Percentage of Participants Who Received Rescue Medication Week 6	16 percentage of participants	15 percentage of participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 6, 8, 10, and 16

In the event of inadequate pain relief or worsening symptoms of chronic prostatitis, participants were allowed to take acetaminophen/paracetamol 500 mg, tablets or capsules as rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes. Participants were followed up to Week 16.	Tanezumab n=22 Participants A single dose of tanezumab (RN624 or PF-04383119) 20 milligram (mg) intravenous infusion over 5 minutes. Participants were followed up to Week 16.
Amount of Rescue Medication Taken Week 4	2764.71 milligram/week Standard Deviation 1977.35	3117.65 milligram/week Standard Deviation 1833.11
Amount of Rescue Medication Taken Week 6	2281.25 milligram/week Standard Deviation 1923.27	3366.67 milligram/week Standard Deviation 2133.63
Amount of Rescue Medication Taken Week 8	2375.00 milligram/week Standard Deviation 1693.91	3500.00 milligram/week Standard Deviation 1605.28
Amount of Rescue Medication Taken Week 16	1375.00 milligram/week Standard Deviation 1436.14	2208.33 milligram/week Standard Deviation 1630.09
Amount of Rescue Medication Taken Week 2	2289.47 milligram/week Standard Deviation 2110.26	2681.82 milligram/week Standard Deviation 1949.03
Amount of Rescue Medication Taken Week 10	3363.64 milligram/week Standard Deviation 2916.26	4000.00 milligram/week Standard Deviation 2500.00

SECONDARY outcome

Timeframe: Day 1 (1 hour pre-dose), Weeks 2, 6, 10, and 16

Population: FAS: all randomized participants who received at least 1 dose of treatment and completed at least 4 diary days during 7 days prior to randomization. Here, 'overall number of participants analyzed' signifies participants evaluable for this measure and 'number analyzed' participants evaluable at specified time point for each arm. Urine NGF levels not analyzed as reliable assay for measurement in urine could not be identified.

Serum NGF level was measured using Immunoaffinity High Performance Liquid Chromatography - Tandem Mass spectrometry (HPLC-MS/MS).

Outcome measures

Outcome measures
Measure	Placebo n=30 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes. Participants were followed up to Week 16.	Tanezumab n=30 Participants A single dose of tanezumab (RN624 or PF-04383119) 20 milligram (mg) intravenous infusion over 5 minutes. Participants were followed up to Week 16.
Serum and Urine Nerve Growth Factor (NGF) Levels Serum NGF: Day 1	33.2 picogram per milliliter (pg/mL) Standard Deviation 8.4	31.1 picogram per milliliter (pg/mL) Standard Deviation 8.8
Serum and Urine Nerve Growth Factor (NGF) Levels Serum NGF: Week 2	40.2 picogram per milliliter (pg/mL) Standard Deviation 12.8	2750 picogram per milliliter (pg/mL) Standard Deviation 583
Serum and Urine Nerve Growth Factor (NGF) Levels Serum NGF: Week 6	37.7 picogram per milliliter (pg/mL) Standard Deviation 11.0	3909 picogram per milliliter (pg/mL) Standard Deviation 768
Serum and Urine Nerve Growth Factor (NGF) Levels Serum NGF: Week 10	34.8 picogram per milliliter (pg/mL) Standard Deviation 12.4	3840 picogram per milliliter (pg/mL) Standard Deviation 925
Serum and Urine Nerve Growth Factor (NGF) Levels Serum NGF: Week 16	35.3 picogram per milliliter (pg/mL) Standard Deviation 11.0	3025 picogram per milliliter (pg/mL) Standard Deviation 1224

SECONDARY outcome

Timeframe: Baseline up to Week 16

Population: Safety analysis set included all randomized participants who had received at least 1 dose of study treatment.

An AE was any untoward medical occurrence in a participant who received study medication 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 medication and up to Week 16 that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial.

Outcome measures

Outcome measures
Measure	Placebo n=32 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes. Participants were followed up to Week 16.	Tanezumab n=30 Participants A single dose of tanezumab (RN624 or PF-04383119) 20 milligram (mg) intravenous infusion over 5 minutes. Participants were followed up to Week 16.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	0 Participants	1 Participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	21 Participants	24 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 16

Population: Safety analysis set included all randomized participants who had received at least 1 dose of study treatment.

A neurological examination assessed the strength of groups of muscles of the head and neck, upper limbs and lower limbs, deep tendon reflexes and sensation (tactile, vibration, joint position sense and pin prick) of index fingers and great toes.

Outcome measures

Outcome measures
Measure	Placebo n=32 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes. Participants were followed up to Week 16.	Tanezumab n=30 Participants A single dose of tanezumab (RN624 or PF-04383119) 20 milligram (mg) intravenous infusion over 5 minutes. Participants were followed up to Week 16.
Number of Participants With Clinically Significant Neurological Examination Abnormalities	1 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 6, and 16

Population: Safety analysis set included all randomized participants who had received at least 1 dose of study treatment. Here, 'number analyzed' signifies those participants who were evaluable at specified time point for each arm, respectively.

PVR volume, an objective assessment of the amount of urine left in the bladder after normal urination and was monitored whether the active treatment had an adverse effect on lower urinary tract voiding function. The PVR volume was assessed using trans-abdominal ultrasound (e.g., bladder scanner) with the participant in a supine position immediately after voluntary urination.

Outcome measures

Outcome measures
Measure	Placebo n=32 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes. Participants were followed up to Week 16.	Tanezumab n=30 Participants A single dose of tanezumab (RN624 or PF-04383119) 20 milligram (mg) intravenous infusion over 5 minutes. Participants were followed up to Week 16.
Post-void Residual (PVR) Volume Baseline	33.8 milliliter Standard Deviation 40.87	34.1 milliliter Standard Deviation 38.87
Post-void Residual (PVR) Volume Week 2	23.2 milliliter Standard Deviation 36.18	19.6 milliliter Standard Deviation 34.11
Post-void Residual (PVR) Volume Week 6	23.4 milliliter Standard Deviation 41.38	31.4 milliliter Standard Deviation 46.74
Post-void Residual (PVR) Volume Week 16	22.5 milliliter Standard Deviation 26.61	26.4 milliliter Standard Deviation 23.60

SECONDARY outcome

Timeframe: Day 1 (1 hour pre-dose), Weeks 2, 6, and 16

Population: Safety analysis set included all randomized participants who had received at least 1 dose of study treatment. Here 'number analyzed' signifies those participants who were evaluable at specified time point for each arm, respectively.

Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi quantitative enzyme-linked immunosorbent assay (ELISA).

Outcome measures

Outcome measures
Measure	Placebo A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes. Participants were followed up to Week 16.	Tanezumab n=30 Participants A single dose of tanezumab (RN624 or PF-04383119) 20 milligram (mg) intravenous infusion over 5 minutes. Participants were followed up to Week 16.
Number of Participants With Anti-Drug Antibody (ADA) Day 1	—	0 Participants
Number of Participants With Anti-Drug Antibody (ADA) Week 2	—	0 Participants
Number of Participants With Anti-Drug Antibody (ADA) Week 6	—	0 Participants
Number of Participants With Anti-Drug Antibody (ADA) Week 16	—	0 Participants

Adverse Events

Tanezumab

Serious events: 1 serious events

Other events: 23 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tanezumab n=30 participants at risk A single dose of tanezumab (RN624 or PF-04383119) 20 milligram (mg) intravenous infusion over 5 minutes. Participants were followed up to Week 16.	Placebo n=32 participants at risk A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes. Participants were followed up to Week 16.
General disorders Device breakage	3.3% 1/30 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.

Other adverse events

Additional Information

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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.
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Restriction type: OTHER