Trial · NCT00826514

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

NCT00826514, Phase 2, Completed, Pfizer; results first posted 2021-05-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. An Efficacy And Safety Study Of Tanezumab For The Treatment Of Pain Associated With Chronic Abacterial Prostatitis. Trials, record NCT00826514. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00826514

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: An Efficacy And Safety Study Of Tanezumab For The Treatment Of Pain Associated With Chronic Abacterial Prostatitis
NCT number: NCT00826514
Status: Completed
Phases: Phase 2
Enrollment: 62 participants, actual
Lead sponsor: Pfizer
Conditions: Chronic Prostatitis With Chronic Pelvic Pain Syndrome
Interventions: Tanezumab, Placebo
First posted: 2009-01-22
Last updated: 2021-05-13
Other registries' IDs: eudract:2008-004861-25
Results first posted: 2021-05-13

Source ClinicalTrials.gov

Registered outcomes22

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Average Daily Pain Score at Week 6	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.
Secondary	Change From Baseline in Average Daily Pain Score at Weeks 2, 4, 8, 10, and 16	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.
Secondary	Change From Baseline in Worst Daily Pain Score at Weeks 2, 4, 6, 8, 10, and 16	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.
Secondary	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, 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.
Secondary	Change From Baseline in Number of Micturitions Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16	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.
Secondary	Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16	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.
Secondary	Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 6, 8, 10, and 16	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.
Secondary	Change From Baseline in Mean Urinary Event Pain Score Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16	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.
Secondary	Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16	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.
Secondary	Change From Baseline in Mean Sleep Disturbance Score Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16	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 disturbance.

1 to 10 of 22Source ClinicalTrials.gov

See all 22 registered outcomes

Outcomes22

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Average Daily Pain Score at Week 6	Baseline, Week 6	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.	units on a scale	MEAN
SECONDARY	Change From Baseline in Average Daily Pain Score at Weeks 2, 4, 8, 10, and 16	Baseline, Weeks 2, 4, 8, 10, and 16	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.	units on a scale	MEAN
SECONDARY	Change From Baseline in Worst Daily Pain Score at Weeks 2, 4, 6, 8, 10, and 16	Baseline, Weeks 2, 4, 6, 8, 10, and 16	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.	units on a scale	MEAN
SECONDARY	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, Weeks 2, 4, 6, 8, 10, and 16	Analysis was performed on rFAS. Here, 'number analyzed' signifies evaluable participants at specified time point for each arm, respectively.	units on a scale	MEAN
SECONDARY	Change From Baseline in Number of Micturitions Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16	Baseline, Week 2, 4, 6, 8, 10, and 16	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.	micturitions per 24 hours	MEAN
SECONDARY	Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16	Baseline, Weeks 2, 4, 6, 8, 10, and 16	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.	micturitions per 24 hours	MEAN
SECONDARY	Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 6, 8, 10, and 16	Baseline, Weeks 2, 4, 6, 8, 10, and 16	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.	milliliter	MEAN
SECONDARY	Change From Baseline in Mean Urinary Event Pain Score Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16	Baseline, Weeks 2, 4, 6, 8, 10, and 16	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.	units on a scale	MEAN
SECONDARY	Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16	Baseline, Weeks 2, 4, 6, 8, 10, and 16	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.	urgency episodes per 24 hours	MEAN
SECONDARY	Change From Baseline in Mean Sleep Disturbance Score Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16	Baseline, Weeks 2, 4, 6, 8, 10, and 16	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.	units on a scale	MEAN

1 to 10 of 22Source ClinicalTrials.gov

See all 22 outcomes

Results by group346

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Average Daily Pain Score at Week 6	Tanezumab	Baseline	5.5	Standard Deviation 1.10	units on a scale
Change From Baseline in Average Daily Pain Score at Week 6	Placebo	Baseline	5.6	Standard Deviation 1.14	units on a scale
Change From Baseline in Average Daily Pain Score at Week 6	Tanezumab	Change at Week 6	-1.4	Standard Deviation 1.43	units on a scale
Change From Baseline in Average Daily Pain Score at Week 6	Placebo	Change at Week 6	-1.0	Standard Deviation 1.43	units on a scale
Change From Baseline in Average Daily Pain Score at Weeks 2, 4, 8, 10, and 16	Tanezumab	Change at Week 2	-0.8	Standard Deviation 1.43	units on a scale
Change From Baseline in Average Daily Pain Score at Weeks 2, 4, 8, 10, and 16	Placebo	Change at Week 2	-1.1	Standard Deviation 1.13	units on a scale
Change From Baseline in Average Daily Pain Score at Weeks 2, 4, 8, 10, and 16	Tanezumab	Change at Week 4	-1.6	Standard Deviation 1.51	units on a scale
Change From Baseline in Average Daily Pain Score at Weeks 2, 4, 8, 10, and 16	Placebo	Change at Week 4	-0.9	Standard Deviation 1.37	units on a scale
Change From Baseline in Average Daily Pain Score at Weeks 2, 4, 8, 10, and 16	Tanezumab	Change at Week 8	-1.5	Standard Deviation 1.46	units on a scale
Change From Baseline in Average Daily Pain Score at Weeks 2, 4, 8, 10, and 16	Placebo	Change at Week 8	-1.3	Standard Deviation 1.61	units on a scale

1 to 10 of 346Source ClinicalTrials.gov

See all 346 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Tanezumab	30
Overall Study	STARTED	Placebo	32
Overall Study	COMPLETED	Tanezumab	27
Overall Study	COMPLETED	Placebo	27
Overall Study	NOT COMPLETED	Tanezumab	3
Overall Study	NOT COMPLETED	Placebo	5

Source ClinicalTrials.gov

Adverse events158

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Leukocytosis	Blood and lymphatic system disorders	Tanezumab	0	30
other	Leukocytosis	Blood and lymphatic system disorders	Placebo	1	32
other	Vision blurred	Eye disorders	Tanezumab	1	30
other	Vision blurred	Eye disorders	Placebo	0	32
other	Abdominal pain lower	Gastrointestinal disorders	Tanezumab	1	30
other	Abdominal pain lower	Gastrointestinal disorders	Placebo	1	32
other	Abdominal pain upper	Gastrointestinal disorders	Tanezumab	1	30
other	Abdominal pain upper	Gastrointestinal disorders	Placebo	1	32
other	Anorectal discomfort	Gastrointestinal disorders	Tanezumab	1	30
other	Anorectal discomfort	Gastrointestinal disorders	Placebo	0	32

1 to 10 of 158Source ClinicalTrials.gov

See all 158 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Tanezumab
Total, all-cause mortality	Placebo
Total, other adverse events	Tanezumab	23	30
Total, other adverse events	Placebo	21	32
Total, serious adverse events	Tanezumab	1	30
Total, serious adverse events	Placebo	0	32

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Tanezumab vs Placebo: Number of Participants With Clinically Significant Neurological Examination Abnormalities	Trial comparisons
Tanezumab vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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GET https://conductscience.org/api/trials/v1/NCT00826514/registered?page=2

API reference For AI assistants