18 and older, male only, with Chronic Prostatitis With Chronic Pelvic Pain Syndrome. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in Average Daily Pain Score at Week 6Primary· Baseline, Week 6
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.
Baseline
Group
Value
95% CI
Tanezumab
5.5
± 1.10
Placebo
5.6
± 1.14
Change at Week 6
Group
Value
95% CI
Tanezumab
-1.4
± 1.43
Placebo
-1.0
± 1.43
Change From Baseline in Average Daily Pain Score at Weeks 2, 4, 8, 10, and 16Secondary· Baseline, Weeks 2, 4, 8, 10, and 16
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.
Change at Week 2
Group
Value
95% CI
Tanezumab
-0.8
± 1.43
Placebo
-1.1
± 1.13
Change at Week 4
Group
Value
95% CI
Tanezumab
-1.6
± 1.51
Placebo
-0.9
± 1.37
Change at Week 8
Group
Value
95% CI
Tanezumab
-1.5
± 1.46
Placebo
-1.3
± 1.61
Change at Week 10
Group
Value
95% CI
Tanezumab
-1.5
± 1.62
Placebo
-1.4
± 1.58
Change at Week 16
Group
Value
95% CI
Tanezumab
-1.8
± 1.30
Placebo
-1.9
± 1.47
Change From Baseline in Worst Daily Pain Score at Weeks 2, 4, 6, 8, 10, and 16Secondary· Baseline, Weeks 2, 4, 6, 8, 10, and 16
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.
Baseline
Group
Value
95% CI
Tanezumab
6.4
± 1.17
Placebo
6.8
± 1.12
Change at Week 2
Group
Value
95% CI
Tanezumab
-0.7
± 1.75
Placebo
-1.2
± 1.31
Change at Week 4
Group
Value
95% CI
Tanezumab
-1.6
± 1.85
Placebo
-0.9
± 1.55
Change at Week 6
Group
Value
95% CI
Tanezumab
-1.4
± 1.95
Placebo
-1.1
± 1.43
Change at Week 8
Group
Value
95% CI
Tanezumab
-1.3
± 2.01
Placebo
-1.4
± 1.86
Change at Week 10
Group
Value
95% CI
Tanezumab
-1.4
± 2.01
Placebo
-1.7
± 1.82
Change at Week 16
Group
Value
95% CI
Tanezumab
-1.8
± 1.79
Placebo
-2.1
± 1.62
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 16Secondary· Baseline, Weeks 2, 4, 6, 8, 10, and 16
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.
Baseline: CPSI Total Score
Group
Value
95% CI
Tanezumab
25.5
± 4.91
Placebo
26.4
± 4.38
Baseline: CPSI Pain Domain (PD) Score
Group
Value
95% CI
Tanezumab
13.0
± 2.09
Placebo
13.5
± 1.85
Baseline: CPSI Urinary Symptom (US) Score
Group
Value
95% CI
Tanezumab
4.2
± 2.39
Placebo
4.1
± 2.88
Baseline: CPSI Quality of Life (QoL) Score
Group
Value
95% CI
Tanezumab
8.3
± 2.18
Placebo
8.8
± 1.87
Change at Week 2: CPSI Total Score
Group
Value
95% CI
Tanezumab
-3.2
± 6.72
Placebo
-3.1
± 5.92
Change at Week 2: CPSI PD Score
Group
Value
95% CI
Tanezumab
-2.3
± 3.44
Placebo
-1.8
± 2.78
Change at Week 2: CPSI US Score
Group
Value
95% CI
Tanezumab
0.2
± 2.25
Placebo
-0.3
± 2.29
Change at Week 2: CPSI QoL Score
Group
Value
95% CI
Tanezumab
-1.0
± 2.47
Placebo
-1.0
± 1.69
Change From Baseline in Number of Micturitions Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16Secondary· 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.
Baseline
Group
Value
95% CI
Tanezumab
9.1
± 3.70
Placebo
9.4
± 4.75
Change at Week 2
Group
Value
95% CI
Tanezumab
0.9
± 2.86
Placebo
-0.3
± 3.32
Change at Week 4
Group
Value
95% CI
Tanezumab
0.3
± 2.45
Placebo
-0.6
± 4.10
Change at Week 6
Group
Value
95% CI
Tanezumab
0.3
± 1.92
Placebo
-0.3
± 3.54
Change at Week 8
Group
Value
95% CI
Tanezumab
0.6
± 3.50
Placebo
-0.7
± 4.69
Change at Week 10
Group
Value
95% CI
Tanezumab
1.0
± 2.92
Placebo
-1.2
± 3.76
Change at Week 16
Group
Value
95% CI
Tanezumab
0.3
± 1.96
Placebo
-0.8
± 4.25
Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16Secondary· Baseline, Weeks 2, 4, 6, 8, 10, and 16
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.
Baseline
Group
Value
95% CI
Tanezumab
3.0
± 3.24
Placebo
3.8
± 3.56
Change at Week 2
Group
Value
95% CI
Tanezumab
-0.2
± 2.45
Placebo
-1.2
± 3.43
Change at Week 4
Group
Value
95% CI
Tanezumab
-0.6
± 3.09
Placebo
-1.2
± 2.65
Change at Week 6
Group
Value
95% CI
Tanezumab
-0.4
± 3.45
Placebo
-0.8
± 3.91
Change at Week 8
Group
Value
95% CI
Tanezumab
0.9
± 3.39
Placebo
0.4
± 3.30
Change at Week 10
Group
Value
95% CI
Tanezumab
-1.0
± 2.77
Placebo
-0.6
± 3.39
Change at Week 16
Group
Value
95% CI
Tanezumab
-0.8
± 1.48
Placebo
-1.4
± 3.89
Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 6, 8, 10, and 16Secondary· 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.
Baseline
Group
Value
95% CI
Tanezumab
216.7
± 90.04
Placebo
208.5
± 86.38
Change at Week 2
Group
Value
95% CI
Tanezumab
-13.8
± 47.95
Placebo
26.8
± 66.13
Change at Week 4
Group
Value
95% CI
Tanezumab
-17.4
± 46.49
Placebo
12.1
± 62.80
Change at Week 6
Group
Value
95% CI
Tanezumab
-24.7
± 58.94
Placebo
8.3
± 68.48
Change at Week 8
Group
Value
95% CI
Tanezumab
-7.4
± 48.11
Placebo
11.0
± 68.07
Change at Week 10
Group
Value
95% CI
Tanezumab
-27.5
± 63.45
Placebo
20.3
± 74.81
Change at Week 16
Group
Value
95% CI
Tanezumab
-27.4
± 48.32
Placebo
15.0
± 67.92
Change From Baseline in Mean Urinary Event Pain Score Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16Secondary· 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.
Baseline
Group
Value
95% CI
Tanezumab
3.0
± 2.37
Placebo
3.6
± 1.99
Change at Week 2
Group
Value
95% CI
Tanezumab
-0.2
± 1.39
Placebo
-0.4
± 1.29
Change at Week 4
Group
Value
95% CI
Tanezumab
-0.7
± 1.41
Placebo
-0.5
± 1.55
Change at Week 6
Group
Value
95% CI
Tanezumab
-0.6
± 1.37
Placebo
-0.3
± 2.03
Change at Week 8
Group
Value
95% CI
Tanezumab
-0.7
± 1.49
Placebo
-0.6
± 1.88
Change at Week 10
Group
Value
95% CI
Tanezumab
-0.6
± 1.32
Placebo
-1.0
± 1.59
Change at Week 16
Group
Value
95% CI
Tanezumab
-0.7
± 1.34
Placebo
-0.8
± 2.04
Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16Secondary· 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.
Baseline
Group
Value
95% CI
Tanezumab
4.7
± 5.65
Placebo
5.1
± 5.50
Change at Week 2
Group
Value
95% CI
Tanezumab
0.3
± 3.14
Placebo
-0.3
± 4.08
Change at Week 4
Group
Value
95% CI
Tanezumab
-0.9
± 3.03
Placebo
0.2
± 5.10
Change at Week 6
Group
Value
95% CI
Tanezumab
-0.8
± 1.44
Placebo
0.0
± 4.90
Change at Week 8
Group
Value
95% CI
Tanezumab
0.3
± 3.59
Placebo
0.6
± 5.86
Change at Week 10
Group
Value
95% CI
Tanezumab
-0.1
± 3.58
Placebo
-0.7
± 5.67
Change at Week 16
Group
Value
95% CI
Tanezumab
-1.4
± 2.25
Placebo
-0.6
± 5.35
Change From Baseline in Mean Sleep Disturbance Score Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16Secondary· Baseline, Weeks 2, 4, 6, 8, 10, and 16
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 dis
Baseline
Group
Value
95% CI
Tanezumab
1.9
± 0.80
Placebo
1.7
± 1.00
Change at Week 2
Group
Value
95% CI
Tanezumab
-0.3
± 0.93
Placebo
-0.4
± 0.54
Change at Week 4
Group
Value
95% CI
Tanezumab
-0.5
± 0.79
Placebo
-0.3
± 0.74
Change at Week 6
Group
Value
95% CI
Tanezumab
-0.4
± 0.88
Placebo
-0.3
± 0.75
Change at Week 8
Group
Value
95% CI
Tanezumab
-0.4
± 0.91
Placebo
-0.4
± 0.79
Change at Week 10
Group
Value
95% CI
Tanezumab
-0.4
± 0.93
Placebo
-0.3
± 0.82
Change at Week 16
Group
Value
95% CI
Tanezumab
-0.4
± 0.81
Placebo
-0.4
± 0.84
Change From Baseline in Mean Pain Score Associated With Ejaculation Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16Secondary· 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.
Baseline
Group
Value
95% CI
Tanezumab
3.8
± 2.40
Placebo
3.4
± 2.50
Change at Week 2
Group
Value
95% CI
Tanezumab
0.3
± 2.47
Placebo
-0.9
± 1.37
Change at Week 4
Group
Value
95% CI
Tanezumab
-1.3
± 1.30
Placebo
-0.3
± 1.87
Change at Week 6
Group
Value
95% CI
Tanezumab
-1.5
± 2.01
Placebo
-0.5
± 1.69
Change at Week 8
Group
Value
95% CI
Tanezumab
-0.4
± 1.94
Placebo
-0.4
± 1.59
Change at Week 10
Group
Value
95% CI
Tanezumab
-1.0
± 2.25
Placebo
-0.7
± 1.68
Change at Week 16
Group
Value
95% CI
Tanezumab
-1.3
± 1.76
Placebo
-1.6
± 1.64
Number of Participants With Global Response Assessment (GRA)Secondary· Week 6 and 16
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
Week 6: Markedly Worse
Group
Value
95% CI
Tanezumab
0
Placebo
1
Week 6: Moderately Worse
Group
Value
95% CI
Tanezumab
2
Placebo
1
Week 6: Slightly Worse
Group
Value
95% CI
Tanezumab
1
Placebo
0
Week 6: No Change
Group
Value
95% CI
Tanezumab
6
Placebo
11
Week 6: Slightly Improved
Group
Value
95% CI
Tanezumab
10
Placebo
7
Week 6: Moderately Improved
Group
Value
95% CI
Tanezumab
3
Placebo
5
Week 6: Markedly Improved
Group
Value
95% CI
Tanezumab
3
Placebo
1
Week 16: Markedly Worse
Group
Value
95% CI
Tanezumab
0
Placebo
0
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 13 May 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00826514.