A Phase 2 interventional study of Tanezumab and Placebo in Chronic Prostatitis With Chronic Pelvic Pain Syndrome, sponsored by Pfizer. Completed at 44 sites in 5 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-13.
Sponsored by Pfizer · Phase 2, Interventional, and Treatment
The purpose of this study is to determine whether tanezumab is effective in the treatment of pain associated with chronic prostatitis.
88 studies on the registry are indexed under Prostatitis; 11 are open to participants now.
This study's enrollment of 62 is close to the median of 60 across 73 interventional studies indexed under Prostatitis.
Browse Prostatitis studies →Pfizer is the lead sponsor of 3,334 studies on the registry; 149 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Tanezumab
Drug: Placebo
Intravenous, 20 mg, single dose.
Intravenous placebo, single dose
Change From Baseline in Average Daily Pain Score at 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.
Time frame: Baseline, Week 6
Change From Baseline in Average Daily Pain Score at 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.
Time frame: Baseline, Weeks 2, 4, 8, 10, and 16
Change From Baseline in Worst Daily Pain Score at 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.
Time frame: Baseline, Weeks 2, 4, 6, 8, 10, and 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
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.
Time frame: Baseline, Weeks 2, 4, 6, 8, 10, and 16
Change From Baseline in Number of Micturitions Per 24 Hours at Weeks 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.
Time frame: Baseline, Week 2, 4, 6, 8, 10, and 16
Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at 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.
Time frame: Baseline, Weeks 2, 4, 6, 8, 10, and 16
Change From Baseline in Mean Voided Volume Per Micturition at 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.
Time frame: Baseline, Weeks 2, 4, 6, 8, 10, and 16
Change From Baseline in Mean Urinary Event Pain Score Per 24 Hours at 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.
Time frame: Baseline, Weeks 2, 4, 6, 8, 10, and 16
Change From Baseline in Urinary Urgency Episodes Per 24 Hours at 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.
Time frame: Baseline, Weeks 2, 4, 6, 8, 10, and 16
Change From Baseline in Mean Sleep Disturbance Score Per 24 Hours at 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.
Time frame: Baseline, Weeks 2, 4, 6, 8, 10, and 16
Change From Baseline in Mean Pain Score Associated With Ejaculation Per 24 Hours at 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.
Time frame: Baseline, Weeks 2, 4, 6, 8, 10, and 16
Number of Participants With Global Response Assessment (GRA)
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.
Time frame: Week 6 and 16
Patient Global Satisfaction Assessment
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.
Time frame: Week 6 and 16
Participant Global Preference
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.
Time frame: Week 6 and 16
Patient Willingness to Re-use Medicine
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.
Time frame: Week 6 and 16
Percentage of Participants Who Received Rescue Medication
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.
Time frame: Weeks 2, 4, 6, 8, 10, and 16
Amount of Rescue Medication Taken
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.
Time frame: Weeks 2, 4, 6, 8, 10, and 16
Serum and Urine Nerve Growth Factor (NGF) Levels
Serum NGF level was measured using Immunoaffinity High Performance Liquid Chromatography - Tandem Mass spectrometry (HPLC-MS/MS).
Time frame: Day 1 (1 hour pre-dose), Weeks 2, 6, 10, and 16
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
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.
Time frame: Baseline up to Week 16
Number of Participants With Clinically Significant Neurological Examination Abnormalities
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.
Time frame: Baseline up to Week 16
Post-void Residual (PVR) Volume
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.
Time frame: Baseline, Weeks 2, 6, and 16
Number of Participants With Anti-Drug Antibody (ADA)
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).
Time frame: Day 1 (1 hour pre-dose), Weeks 2, 6, and 16
| Milestone | Tanezumab | Placebo |
|---|---|---|
| Started | 30 | 32 |
| Completed | 27 | 27 |
| Not completed | 3 | 5 |
| Withdrew: Adverse event | 1 | 1 |
| Withdrew: Lack of efficacy | 0 | 1 |
| Withdrew: Withdrawal by subject | 2 | 3 |
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.
| units on a scale | Tanezumab | Placebo |
|---|---|---|
| Baseline | 5.5 ± 1.10 | 5.6 ± 1.14 |
| Change at Week 6 | -1.4 ± 1.43 | -1.0 ± 1.43 |
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.
| units on a scale | Tanezumab | Placebo |
|---|---|---|
| Change at Week 2 | -0.8 ± 1.43 | -1.1 ± 1.13 |
| Change at Week 4 | -1.6 ± 1.51 | -0.9 ± 1.37 |
| Change at Week 8 | -1.5 ± 1.46 | -1.3 ± 1.61 |
| Change at Week 10 | -1.5 ± 1.62 | -1.4 ± 1.58 |
| Change at Week 16 | -1.8 ± 1.30 | -1.9 ± 1.47 |
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.
| units on a scale | Tanezumab | Placebo |
|---|---|---|
| Baseline | 6.4 ± 1.17 | 6.8 ± 1.12 |
| Change at Week 2 | -0.7 ± 1.75 | -1.2 ± 1.31 |
| Change at Week 4 | -1.6 ± 1.85 | -0.9 ± 1.55 |
| Change at Week 6 | -1.4 ± 1.95 | -1.1 ± 1.43 |
| Change at Week 8 | -1.3 ± 2.01 | -1.4 ± 1.86 |
| Change at Week 10 | -1.4 ± 2.01 | -1.7 ± 1.82 |
| Change at Week 16 | -1.8 ± 1.79 | -2.1 ± 1.62 |
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.
| units on a scale | Tanezumab | Placebo |
|---|---|---|
| Baseline: CPSI Total Score | 25.5 ± 4.91 | 26.4 ± 4.38 |
| Baseline: CPSI Pain Domain (PD) Score | 13.0 ± 2.09 | 13.5 ± 1.85 |
| Baseline: CPSI Urinary Symptom (US) Score | 4.2 ± 2.39 | 4.1 ± 2.88 |
| Baseline: CPSI Quality of Life (QoL) Score | 8.3 ± 2.18 | 8.8 ± 1.87 |
| Change at Week 2: CPSI Total Score | -3.2 ± 6.72 | -3.1 ± 5.92 |
| Change at Week 2: CPSI PD Score | -2.3 ± 3.44 | -1.8 ± 2.78 |
| Change at Week 2: CPSI US Score | 0.2 ± 2.25 | -0.3 ± 2.29 |
| Change at Week 2: CPSI QoL Score | -1.0 ± 2.47 | -1.0 ± 1.69 |
| Change at Week 4: CPSI Total Score | -5.2 ± 6.56 | -3.5 ± 6.27 |
| Change at Week 4: CPSI PD Score | -3.5 ± 3.63 | -2.0 ± 2.72 |
| Change at Week 4: CPSI US Score | 0.1 ± 2.44 | -0.7 ± 2.80 |
| Change at Week 4: CPSI QoL Score | -1.8 ± 2.71 | -0.9 ± 1.96 |
| Change at Week 6: CPSI Total Score | -4.3 ± 7.04 | -4.0 ± 7.06 |
| Change at Week 6: CPSI PD Score | -2.8 ± 3.64 | -2.2 ± 2.94 |
| Change at Week 6: CPSI US Score | -0.2 ± 2.38 | -0.8 ± 3.18 |
| Change at Week 6: CPSI QoL Score | -1.3 ± 2.67 | -1.0 ± 2.32 |
| Change at Week 8: CPSI Total Score | -3.0 ± 5.73 | -4.8 ± 7.55 |
| Change at Week 8: CPSI PD Score | -2.1 ± 3.15 | -2.9 ± 3.97 |
| Change at Week 8: CPSI US Score | -0.0 ± 1.72 | -0.5 ± 2.65 |
| Change at Week 8: CPSI QoL Score | -0.8 ± 2.36 | -1.4 ± 2.48 |
| Change at Week 10: CPSI Total Score | -2.9 ± 6.06 | -4.9 ± 7.62 |
| Change at Week 10: CPSI PD Score | -2.4 ± 3.56 | -3.0 ± 3.64 |
| Change at Week 10: CPSI US Score | 0.6 ± 1.96 | -0.7 ± 2.59 |
| Change at Week 10: CPSI QoL Score | -1.1 ± 2.20 | -1.2 ± 2.87 |
| Change at Week 16: CPSI Total Score | -4.0 ± 6.34 | -5.3 ± 7.62 |
| Change at Week 16: CPSI PD Score | -2.4 ± 3.06 | -3.2 ± 3.93 |
| Change at Week 16: CPSI US Score | -0.3 ± 2.08 | -0.5 ± 2.76 |
| Change at Week 16: CPSI QoL Score | -1.2 ± 2.35 | -1.6 ± 2.59 |
The micturition frequency per 24 hours was calculated from the sum of voluntary voids divided by the diary period over which they were collected.
| micturitions per 24 hours | Tanezumab | Placebo |
|---|---|---|
| Baseline | 9.1 ± 3.70 | 9.4 ± 4.75 |
| Change at Week 2 | 0.9 ± 2.86 | -0.3 ± 3.32 |
| Change at Week 4 | 0.3 ± 2.45 | -0.6 ± 4.10 |
| Change at Week 6 | 0.3 ± 1.92 | -0.3 ± 3.54 |
| Change at Week 8 | 0.6 ± 3.50 | -0.7 ± 4.69 |
| Change at Week 10 | 1.0 ± 2.92 | -1.2 ± 3.76 |
| Change at Week 16 | 0.3 ± 1.96 | -0.8 ± 4.25 |
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.
| micturitions per 24 hours | Tanezumab | Placebo |
|---|---|---|
| Baseline | 3.0 ± 3.24 | 3.8 ± 3.56 |
| Change at Week 2 | -0.2 ± 2.45 | -1.2 ± 3.43 |
| Change at Week 4 | -0.6 ± 3.09 | -1.2 ± 2.65 |
| Change at Week 6 | -0.4 ± 3.45 | -0.8 ± 3.91 |
| Change at Week 8 | 0.9 ± 3.39 | 0.4 ± 3.30 |
| Change at Week 10 | -1.0 ± 2.77 | -0.6 ± 3.39 |
| Change at Week 16 | -0.8 ± 1.48 | -1.4 ± 3.89 |
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.
| milliliter | Tanezumab | Placebo |
|---|---|---|
| Baseline | 216.7 ± 90.04 | 208.5 ± 86.38 |
| Change at Week 2 | -13.8 ± 47.95 | 26.8 ± 66.13 |
| Change at Week 4 | -17.4 ± 46.49 | 12.1 ± 62.80 |
| Change at Week 6 | -24.7 ± 58.94 | 8.3 ± 68.48 |
| Change at Week 8 | -7.4 ± 48.11 | 11.0 ± 68.07 |
| Change at Week 10 | -27.5 ± 63.45 | 20.3 ± 74.81 |
| Change at Week 16 | -27.4 ± 48.32 | 15.0 ± 67.92 |
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.
| units on a scale | Tanezumab | Placebo |
|---|---|---|
| Baseline | 3.0 ± 2.37 | 3.6 ± 1.99 |
| Change at Week 2 | -0.2 ± 1.39 | -0.4 ± 1.29 |
| Change at Week 4 | -0.7 ± 1.41 | -0.5 ± 1.55 |
| Change at Week 6 | -0.6 ± 1.37 | -0.3 ± 2.03 |
| Change at Week 8 | -0.7 ± 1.49 | -0.6 ± 1.88 |
| Change at Week 10 | -0.6 ± 1.32 | -1.0 ± 1.59 |
| Change at Week 16 | -0.7 ± 1.34 | -0.8 ± 2.04 |
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.
| urgency episodes per 24 hours | Tanezumab | Placebo |
|---|---|---|
| Baseline | 4.7 ± 5.65 | 5.1 ± 5.50 |
| Change at Week 2 | 0.3 ± 3.14 | -0.3 ± 4.08 |
| Change at Week 4 | -0.9 ± 3.03 | 0.2 ± 5.10 |
| Change at Week 6 | -0.8 ± 1.44 | 0.0 ± 4.90 |
| Change at Week 8 | 0.3 ± 3.59 | 0.6 ± 5.86 |
| Change at Week 10 | -0.1 ± 3.58 | -0.7 ± 5.67 |
| Change at Week 16 | -1.4 ± 2.25 | -0.6 ± 5.35 |
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.
| units on a scale | Tanezumab | Placebo |
|---|---|---|
| Baseline | 1.9 ± 0.80 | 1.7 ± 1.00 |
| Change at Week 2 | -0.3 ± 0.93 | -0.4 ± 0.54 |
| Change at Week 4 | -0.5 ± 0.79 | -0.3 ± 0.74 |
| Change at Week 6 | -0.4 ± 0.88 | -0.3 ± 0.75 |
| Change at Week 8 | -0.4 ± 0.91 | -0.4 ± 0.79 |
| Change at Week 10 | -0.4 ± 0.93 | -0.3 ± 0.82 |
| Change at Week 16 | -0.4 ± 0.81 | -0.4 ± 0.84 |
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.
| units on a scale | Tanezumab | Placebo |
|---|---|---|
| Baseline | 3.8 ± 2.40 | 3.4 ± 2.50 |
| Change at Week 2 | 0.3 ± 2.47 | -0.9 ± 1.37 |
| Change at Week 4 | -1.3 ± 1.30 | -0.3 ± 1.87 |
| Change at Week 6 | -1.5 ± 2.01 | -0.5 ± 1.69 |
| Change at Week 8 | -0.4 ± 1.94 | -0.4 ± 1.59 |
| Change at Week 10 | -1.0 ± 2.25 | -0.7 ± 1.68 |
| Change at Week 16 | -1.3 ± 1.76 | -1.6 ± 1.64 |
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.
| Participants | Tanezumab | Placebo |
|---|---|---|
| Week 6: Markedly Worse | 0 | 1 |
| Week 6: Moderately Worse | 2 | 1 |
| Week 6: Slightly Worse | 1 | 0 |
| Week 6: No Change | 6 | 11 |
| Week 6: Slightly Improved | 10 | 7 |
| Week 6: Moderately Improved | 3 | 5 |
| Week 6: Markedly Improved | 3 | 1 |
| Week 16: Markedly Worse | 0 | 0 |
| Week 16: Moderately Worse | 0 | 0 |
| Week 16: Slightly Worse | 1 | 0 |
| Week 16: No Change | 9 | 8 |
| Week 16: Slightly Improved | 8 | 6 |
| Week 16: Moderately Improved | 4 | 6 |
| Week 16: Markedly Improved | 1 | 1 |
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.
| Participants | Tanezumab | Placebo |
|---|---|---|
| Week 6: Extremely Satisfied | 3 | 0 |
| Week 6: Satisfied | 5 | 5 |
| Week 6:Neither Satisfied nor Dissatisfied | 10 | 13 |
| Week 6: Dissatisfied | 5 | 3 |
| Week 6: Extremely Dissatisfied | 2 | 3 |
| Week 16: Extremely Satisfied | 4 | 1 |
| Week 16: Satisfied | 7 | 11 |
| Week16:Neither Satisfied nor Dissatisfied | 5 | 7 |
| Week 16: Dissatisfied | 5 | 1 |
| Week 16: Extremely Dissatisfied | 2 | 2 |
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.
| Participants | Tanezumab | Placebo |
|---|---|---|
| Week 6: Lifestyle Interventions | 5 | 5 |
| Week 6: Physical Therapies | 2 | 4 |
| Week 6: Training Programs | 2 | 0 |
| Week 6:Drug treatment-taken by mouth | 19 | 14 |
| Week 6: Surgery/other prostate procedure | 0 | 2 |
| Week 6: No Treatment | 6 | 4 |
| Week 6: Definitely Prefer Current Drug | 4 | 5 |
| Week 6: Slight Preference for Current Drug | 7 | 5 |
| Week 6: No Preference | 13 | 12 |
| Week 6: Slight Preference, Prior Treatment | 0 | 0 |
| Week 6: Definitely Prefer Prior Treatment | 1 | 2 |
| Week 16: Lifestyle Interventions | 7 | 7 |
| Week 16: Physical Therapies | 3 | 4 |
| Week 16: Training Programs | 3 | 3 |
| Week 16: Drug treatment-taken by mouth | 17 | 18 |
| Week 16: Surgery/other prostate procedure | 1 | 0 |
| Week 16: No Treatment | 3 | 1 |
| Week 16: Definitely Prefer Current Drug | 9 | 8 |
| Week 16: Slight Preference for Current Drug | 4 | 5 |
| Week 16: No Preference | 8 | 6 |
| Week 16: Slight Preference, Prior Treatment | 0 | 0 |
| Week 16: Definitely Prefer Prior Treatment | 2 | 3 |
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.
| Participants | Tanezumab | Placebo |
|---|---|---|
| Week 6: Definitely Want | 6 | 8 |
| Week 6: Might Want | 6 | 4 |
| Week 6: Not Sure | 8 | 9 |
| Week 6: Might not Want | 2 | 0 |
| Week 6: Definitely Would not Want | 3 | 3 |
| Week 16: Definitely Want | 10 | 11 |
| Week 16: Might Want | 3 | 7 |
| Week 16: Not Sure | 4 | 1 |
| Week 16: Might not Want | 3 | 0 |
| Week 16: Definitely Would not Want | 3 | 3 |
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.
| percentage of participants | Tanezumab | Placebo |
|---|---|---|
| Week 2 | 22 | 19 |
| Week 4 | 17 | 17 |
| Week 6 | 15 | 16 |
| Week 8 | 14 | 12 |
| Week 10 | 13 | 11 |
| Week 16 | 12 | 4 |
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.
| milligram/week | Tanezumab | Placebo |
|---|---|---|
| Week 2 | 2681.82 ± 1949.03 | 2289.47 ± 2110.26 |
| Week 4 | 3117.65 ± 1833.11 | 2764.71 ± 1977.35 |
| Week 6 | 3366.67 ± 2133.63 | 2281.25 ± 1923.27 |
| Week 8 | 3500.00 ± 1605.28 | 2375.00 ± 1693.91 |
| Week 10 | 4000.00 ± 2500.00 | 3363.64 ± 2916.26 |
| Week 16 | 2208.33 ± 1630.09 | 1375.00 ± 1436.14 |
Serum NGF level was measured using Immunoaffinity High Performance Liquid Chromatography - Tandem Mass spectrometry (HPLC-MS/MS).
| picogram per milliliter (pg/mL) | Tanezumab | Placebo |
|---|---|---|
| Serum NGF: Day 1 | 31.1 ± 8.8 | 33.2 ± 8.4 |
| Serum NGF: Week 2 | 2750 ± 583 | 40.2 ± 12.8 |
| Serum NGF: Week 6 | 3909 ± 768 | 37.7 ± 11.0 |
| Serum NGF: Week 10 | 3840 ± 925 | 34.8 ± 12.4 |
| Serum NGF: Week 16 | 3025 ± 1224 | 35.3 ± 11.0 |
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.
| Participants | Tanezumab | Placebo |
|---|---|---|
| AEs | 24 | 21 |
| SAEs | 1 | 0 |
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.
| Participants | Tanezumab | Placebo |
|---|---|---|
| Number of Participants With Clinically Significant Neurological Examination Abnormalities | 3 | 1 |
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.
| milliliter | Tanezumab | Placebo |
|---|---|---|
| Baseline | 34.1 ± 38.87 | 33.8 ± 40.87 |
| Week 2 | 19.6 ± 34.11 | 23.2 ± 36.18 |
| Week 6 | 31.4 ± 46.74 | 23.4 ± 41.38 |
| Week 16 | 26.4 ± 23.60 | 22.5 ± 26.61 |
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).
| Participants | Tanezumab |
|---|---|
| Day 1 | 0 |
| Week 2 | 0 |
| Week 6 | 0 |
| Week 16 | 0 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tanezumab | — | 1/30 (3.3%) | 23/30 (76.7%) |
| Placebo | — | 0/32 (0%) | 21/32 (65.6%) |
| Event | Tanezumab | Placebo |
|---|---|---|
| Device breakageGeneral disorders | 1/30 | 0/32 |
| Event | Tanezumab | Placebo |
|---|---|---|
| ParaesthesiaNervous system disorders | 8/30 | 2/32 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 7/30 | 0/32 |
| HeadacheNervous system disorders | 6/30 | 2/32 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 5/30 | 1/32 |
| AllodyniaNervous system disorders | 4/30 | 0/32 |
| InsomniaPsychiatric disorders | 3/30 | 1/32 |
| DizzinessNervous system disorders | 2/30 | 3/32 |
| DiarrhoeaGastrointestinal disorders | 2/30 | 1/32 |
| Limb discomfortMusculoskeletal and connective tissue disorders | 2/30 | 0/32 |
| Muscle spasmsMusculoskeletal and connective tissue disorders | 2/30 | 0/32 |
Safety analysis set included all randomized participants who had received at least 1 dose of study treatment.
| Age, Customized(Participants) | Tanezumab | Placebo | Total |
|---|---|---|---|
| 18 to 44 years | 8 | 18 | 26 |
| 45 to 64 years | 17 | 12 | 29 |
| Greater than or equal to (>=) 65 years | 5 | 2 | 7 |
| Sex: Female, Male(Participants) | Tanezumab | Placebo | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 30 | 32 | 62 |
Plan to share: Yes — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Data sharing details ↗ · www.pfizer.com
Ran from Mar 2009 to primary completion in Jan 2010, 9 months.
Results were first posted in May 2021, 11 years 4 months after primary completion. A results delay was requested in Mar 2011.
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Studies of the drug tested here: Tanezumab