Chronic Prostatitis With Chronic Pelvic Pain Syndrome
Conditions
Keywords
Chronic Prostatis
Brief summary
The purpose of this study is to determine whether tanezumab is effective in the treatment of pain associated with chronic prostatitis.
Interventions
DRUGTanezumab
Intravenous, 20 mg, single dose.
DRUGPlacebo
Intravenous placebo, single dose
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of chronic prostatitis * Male adults at least 18 years of age * Moderate to severe chronic prostatitis, with an average pain score above a pre-defined level * To use contraception.
Exclusion criteria
* History of symptoms for less than 3 of the last 6 months * History of recurrent urinary tract infections, or genito-urinary cancer * Use of finasteride or dutasteride within 6 months. * History of hepatitis B, C or human immunodeficiency virus (HIV)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Change From Baseline in Mean Pain Score Associated With Ejaculation Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 | 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. |
| Number of Participants With Global Response Assessment (GRA) | 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 1 to 7, where higher score indicated improvement. |
| 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. |
| Participant Global Preference | Week 6 and 16 | 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. |
| Patient Willingness to Re-use Medicine | 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. |
| Percentage of Participants Who Received Rescue Medication | 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. |
| Amount of Rescue Medication Taken | 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. |
| Serum and Urine Nerve Growth Factor (NGF) Levels | Day 1 (1 hour pre-dose), Weeks 2, 6, 10, and 16 | Serum NGF level was measured using Immunoaffinity High Performance Liquid Chromatography - Tandem Mass spectrometry (HPLC-MS/MS). |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to Week 16 | 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. |
| Number of Participants With Clinically Significant Neurological Examination Abnormalities | Baseline up to Week 16 | 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. |
| Post-void Residual (PVR) Volume | Baseline, Weeks 2, 6, and 16 | 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. |
| Number of Participants With Anti-Drug Antibody (ADA) | Day 1 (1 hour pre-dose), Weeks 2, 6, and 16 | 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). |
| Patient Global Satisfaction Assessment | 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. |
Countries
Canada, France, Sweden, Switzerland, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| 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. | 32 |
| Total | 62 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Lack of Efficacy | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 3 |
Baseline characteristics
| Characteristic | Tanezumab | Placebo | Total |
|---|---|---|---|
| Age, Customized 18 to 44 years | 8 Participants | 18 Participants | 26 Participants |
| Age, Customized 45 to 64 years | 17 Participants | 12 Participants | 29 Participants |
| Age, Customized Greater than or equal to (>=) 65 years | 5 Participants | 2 Participants | 7 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 30 Participants | 32 Participants | 62 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 23 / 30 | 21 / 32 |
| serious Total, serious adverse events | 1 / 30 | 0 / 32 |
Outcome results
Primary
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Change From Baseline in Average Daily Pain Score at Week 6 | Baseline | 5.5 units on a scale | Standard Deviation 1.1 |
| Tanezumab | Change From Baseline in Average Daily Pain Score at Week 6 | Change at Week 6 | -1.4 units on a scale | Standard Deviation 1.43 |
| Placebo | Change From Baseline in Average Daily Pain Score at Week 6 | Baseline | 5.6 units on a scale | Standard Deviation 1.14 |
| Placebo | 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 |
Comparison: Analysis was based on analysis of co-variance (ANCOVA) model with baseline value, age and treatment as covariates.95% CI: [-1.15, 0.209]
Secondary
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Amount of Rescue Medication Taken | Week 4 | 3117.65 milligram/week | Standard Deviation 1833.11 |
| Tanezumab | Amount of Rescue Medication Taken | Week 8 | 3500.00 milligram/week | Standard Deviation 1605.28 |
| Tanezumab | Amount of Rescue Medication Taken | Week 2 | 2681.82 milligram/week | Standard Deviation 1949.03 |
| Tanezumab | Amount of Rescue Medication Taken | Week 6 | 3366.67 milligram/week | Standard Deviation 2133.63 |
| Tanezumab | Amount of Rescue Medication Taken | Week 16 | 2208.33 milligram/week | Standard Deviation 1630.09 |
| Tanezumab | Amount of Rescue Medication Taken | Week 10 | 4000.00 milligram/week | Standard Deviation 2500 |
| Placebo | Amount of Rescue Medication Taken | Week 16 | 1375.00 milligram/week | Standard Deviation 1436.14 |
| Placebo | Amount of Rescue Medication Taken | Week 2 | 2289.47 milligram/week | Standard Deviation 2110.26 |
| Placebo | Amount of Rescue Medication Taken | Week 4 | 2764.71 milligram/week | Standard Deviation 1977.35 |
| Placebo | Amount of Rescue Medication Taken | Week 6 | 2281.25 milligram/week | Standard Deviation 1923.27 |
| Placebo | Amount of Rescue Medication Taken | Week 8 | 2375.00 milligram/week | Standard Deviation 1693.91 |
| Placebo | Amount of Rescue Medication Taken | Week 10 | 3363.64 milligram/week | Standard Deviation 2916.26 |
Secondary
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Change From Baseline in Average Daily Pain Score at Weeks 2, 4, 8, 10, and 16 | Change at Week 4 | -1.6 units on a scale | Standard Deviation 1.51 |
| Tanezumab | Change From Baseline in Average Daily Pain Score at Weeks 2, 4, 8, 10, and 16 | Change at Week 10 | -1.5 units on a scale | Standard Deviation 1.62 |
| Tanezumab | Change From Baseline in Average Daily Pain Score at Weeks 2, 4, 8, 10, and 16 | Change at Week 8 | -1.5 units on a scale | Standard Deviation 1.46 |
| Tanezumab | Change From Baseline in Average Daily Pain Score at Weeks 2, 4, 8, 10, and 16 | Change at Week 16 | -1.8 units on a scale | Standard Deviation 1.3 |
| Tanezumab | Change From Baseline in Average Daily Pain Score at Weeks 2, 4, 8, 10, and 16 | Change at Week 2 | -0.8 units on a scale | Standard Deviation 1.43 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
Secondary
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | 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 | -1.3 units on a scale | Standard Deviation 1.3 |
| Tanezumab | 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 1.94 |
| Tanezumab | 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 | 0.3 units on a scale | Standard Deviation 2.47 |
| Tanezumab | 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 | -1.0 units on a scale | Standard Deviation 2.25 |
| Tanezumab | 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 | -1.5 units on a scale | Standard Deviation 2.01 |
| Tanezumab | 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 | -1.3 units on a scale | Standard Deviation 1.76 |
| Tanezumab | Change From Baseline in Mean Pain Score Associated With Ejaculation Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 | Baseline | 3.8 units on a scale | Standard Deviation 2.4 |
| Placebo | 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 |
| Placebo | 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 2.5 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
Comparison: Change at Week 6: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.90% CI: [-1.791, 1.822]
Secondary
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Change From Baseline in Mean Sleep Disturbance Score Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 | Change at Week 4 | -0.5 units on a scale | Standard Deviation 0.79 |
| Tanezumab | 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 0.91 |
| Tanezumab | Change From Baseline in Mean Sleep Disturbance Score Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 | Change at Week 2 | -0.3 units on a scale | Standard Deviation 0.93 |
| Tanezumab | Change From Baseline in Mean Sleep Disturbance Score Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 | Change at Week 10 | -0.4 units on a scale | Standard Deviation 0.93 |
| Tanezumab | Change From Baseline in Mean Sleep Disturbance Score Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 | Change at Week 6 | -0.4 units on a scale | Standard Deviation 0.88 |
| Tanezumab | 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 0.81 |
| Tanezumab | Change From Baseline in Mean Sleep Disturbance Score Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 | Baseline | 1.9 units on a scale | Standard Deviation 0.8 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
Comparison: Change at Week 6: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.90% CI: [-0.417, 0.334]
Secondary
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | 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 | -0.7 units on a scale | Standard Deviation 1.41 |
| Tanezumab | 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 | -0.7 units on a scale | Standard Deviation 1.49 |
| Tanezumab | 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 | -0.2 units on a scale | Standard Deviation 1.39 |
| Tanezumab | 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 | -0.6 units on a scale | Standard Deviation 1.32 |
| Tanezumab | 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 | -0.6 units on a scale | Standard Deviation 1.37 |
| Tanezumab | 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 | -0.7 units on a scale | Standard Deviation 1.34 |
| Tanezumab | Change From Baseline in Mean Urinary Event Pain Score Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 | Baseline | 3.0 units on a scale | Standard Deviation 2.37 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
Comparison: Change at Week 6: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.90% CI: [-1.364, 0.415]
Secondary
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 6, 8, 10, and 16 | Change at Week 2 | -13.8 milliliter | Standard Deviation 47.95 |
| Tanezumab | Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 6, 8, 10, and 16 | Change at Week 8 | -7.4 milliliter | Standard Deviation 48.11 |
| Tanezumab | Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 6, 8, 10, and 16 | Change at Week 4 | -17.4 milliliter | Standard Deviation 46.49 |
| Tanezumab | Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 6, 8, 10, and 16 | Change at Week 10 | -27.5 milliliter | Standard Deviation 63.45 |
| Tanezumab | Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 6, 8, 10, and 16 | Baseline | 216.7 milliliter | Standard Deviation 90.04 |
| Tanezumab | Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 6, 8, 10, and 16 | Change at Week 16 | -27.4 milliliter | Standard Deviation 48.32 |
| Tanezumab | Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 6, 8, 10, and 16 | Change at Week 6 | -24.7 milliliter | Standard Deviation 58.94 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 62.8 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
Comparison: Change at Week 6: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.90% CI: [-64.144, -2.968]
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
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
Population: Analysis was performed on rFAS. Here, 'number analyzed' signifies evaluable participants at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | 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 | -0.2 units on a scale | Standard Deviation 2.38 |
| Tanezumab | 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 | -3.2 units on a scale | Standard Deviation 6.72 |
| Tanezumab | 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 | -1.3 units on a scale | Standard Deviation 2.67 |
| Tanezumab | 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 | -5.2 units on a scale | Standard Deviation 6.56 |
| Tanezumab | 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 | -3.0 units on a scale | Standard Deviation 5.73 |
| Tanezumab | 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 | 13.0 units on a scale | Standard Deviation 2.09 |
| Tanezumab | 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 | -2.1 units on a scale | Standard Deviation 3.15 |
| Tanezumab | 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 | -3.5 units on a scale | Standard Deviation 3.63 |
| Tanezumab | 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 | -0.0 units on a scale | Standard Deviation 1.72 |
| Tanezumab | 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 | -2.3 units on a scale | Standard Deviation 3.44 |
| Tanezumab | 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 | -0.8 units on a scale | Standard Deviation 2.36 |
| Tanezumab | 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 | 0.1 units on a scale | Standard Deviation 2.44 |
| Tanezumab | 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 | -2.9 units on a scale | Standard Deviation 6.06 |
| Tanezumab | 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 | 8.3 units on a scale | Standard Deviation 2.18 |
| Tanezumab | 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 | -2.4 units on a scale | Standard Deviation 3.56 |
| Tanezumab | 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 | -1.8 units on a scale | Standard Deviation 2.71 |
| Tanezumab | 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 | 0.6 units on a scale | Standard Deviation 1.96 |
| Tanezumab | 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 | 0.2 units on a scale | Standard Deviation 2.25 |
| Tanezumab | 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 | -1.1 units on a scale | Standard Deviation 2.2 |
| Tanezumab | 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 | -4.3 units on a scale | Standard Deviation 7.04 |
| Tanezumab | 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 | -4.0 units on a scale | Standard Deviation 6.34 |
| Tanezumab | 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 | 4.2 units on a scale | Standard Deviation 2.39 |
| Tanezumab | 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 | -2.4 units on a scale | Standard Deviation 3.06 |
| Tanezumab | 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 | -2.8 units on a scale | Standard Deviation 3.64 |
| Tanezumab | 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 | -0.3 units on a scale | Standard Deviation 2.08 |
| Tanezumab | 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 2.47 |
| Tanezumab | 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 | -1.2 units on a scale | Standard Deviation 2.35 |
| Tanezumab | 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 | 25.5 units on a scale | Standard Deviation 4.91 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 2.8 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
Comparison: Change at Week 6, CPSI Total Score: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.90% CI: [-4.754, 1.905]
Comparison: Change at Week 6, CPSI PD Score: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.90% CI: [-2.701, 0.591]
Comparison: Change at Week 6, CPSI US Score: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.90% CI: [-0.789, 1.541]
Comparison: Change at Week 6, CPSI QoL Score: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.90% CI: [-1.785, 0.631]
Secondary
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Change From Baseline in Number of Micturitions Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 | Change at Week 4 | 0.3 micturitions per 24 hours | Standard Deviation 2.45 |
| Tanezumab | Change From Baseline in Number of Micturitions Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 | Change at Week 8 | 0.6 micturitions per 24 hours | Standard Deviation 3.5 |
| Tanezumab | Change From Baseline in Number of Micturitions Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 | Change at Week 2 | 0.9 micturitions per 24 hours | Standard Deviation 2.86 |
| Tanezumab | Change From Baseline in Number of Micturitions Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 | Change at Week 10 | 1.0 micturitions per 24 hours | Standard Deviation 2.92 |
| Tanezumab | 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 1.92 |
| Tanezumab | Change From Baseline in Number of Micturitions Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 | Change at Week 16 | 0.3 micturitions per 24 hours | Standard Deviation 1.96 |
| Tanezumab | Change From Baseline in Number of Micturitions Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 | Baseline | 9.1 micturitions per 24 hours | Standard Deviation 3.7 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 4.1 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
Comparison: Change at Week 6: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.90% CI: [-0.99, 1.348]
Secondary
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Change From Baseline in Number of Nocturnal 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 3.09 |
| Tanezumab | Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 | Change at Week 8 | 0.9 micturitions per 24 hours | Standard Deviation 3.39 |
| Tanezumab | Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 | Change at Week 2 | -0.2 micturitions per 24 hours | Standard Deviation 2.45 |
| Tanezumab | Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 | Change at Week 10 | -1.0 micturitions per 24 hours | Standard Deviation 2.77 |
| Tanezumab | Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 | Change at Week 6 | -0.4 micturitions per 24 hours | Standard Deviation 3.45 |
| Tanezumab | Change From Baseline in Number of Nocturnal 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 1.48 |
| Tanezumab | Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 | Baseline | 3.0 micturitions per 24 hours | Standard Deviation 3.24 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 3.3 |
| Placebo | 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 |
Comparison: Change at Week 6: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.90% CI: [-1.829, 1.452]
Secondary
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 | Change at Week 4 | -0.9 urgency episodes per 24 hours | Standard Deviation 3.03 |
| Tanezumab | Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 | Change at Week 8 | 0.3 urgency episodes per 24 hours | Standard Deviation 3.59 |
| Tanezumab | 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 3.14 |
| Tanezumab | Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 | Change at Week 10 | -0.1 urgency episodes per 24 hours | Standard Deviation 3.58 |
| Tanezumab | Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 | Change at Week 6 | -0.8 urgency episodes per 24 hours | Standard Deviation 1.44 |
| Tanezumab | Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 | Change at Week 16 | -1.4 urgency episodes per 24 hours | Standard Deviation 2.25 |
| Tanezumab | Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16 | Baseline | 4.7 urgency episodes per 24 hours | Standard Deviation 5.65 |
| Placebo | 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 |
| Placebo | 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 5.5 |
| Placebo | 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 |
| Placebo | 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 5.1 |
| Placebo | 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 4.9 |
| Placebo | 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 |
| Placebo | 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 |
Comparison: Change at Week 6: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.90% CI: [-3.146, 0.401]
Secondary
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Change From Baseline in Worst Daily Pain Score at Weeks 2, 4, 6, 8, 10, and 16 | Change at Week 4 | -1.6 units on a scale | Standard Deviation 1.85 |
| Tanezumab | Change From Baseline in Worst Daily Pain Score at Weeks 2, 4, 6, 8, 10, and 16 | Change at Week 8 | -1.3 units on a scale | Standard Deviation 2.01 |
| Tanezumab | Change From Baseline in Worst Daily Pain Score at Weeks 2, 4, 6, 8, 10, and 16 | Change at Week 2 | -0.7 units on a scale | Standard Deviation 1.75 |
| Tanezumab | Change From Baseline in Worst Daily Pain Score at Weeks 2, 4, 6, 8, 10, and 16 | Change at Week 10 | -1.4 units on a scale | Standard Deviation 2.01 |
| Tanezumab | Change From Baseline in Worst Daily Pain Score at Weeks 2, 4, 6, 8, 10, and 16 | Change at Week 6 | -1.4 units on a scale | Standard Deviation 1.95 |
| Tanezumab | Change From Baseline in Worst Daily Pain Score at Weeks 2, 4, 6, 8, 10, and 16 | Change at Week 16 | -1.8 units on a scale | Standard Deviation 1.79 |
| Tanezumab | Change From Baseline in Worst Daily Pain Score at Weeks 2, 4, 6, 8, 10, and 16 | Baseline | 6.4 units on a scale | Standard Deviation 1.17 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
Secondary
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
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanezumab | Number of Participants With Anti-Drug Antibody (ADA) | Day 1 | 0 Participants |
| Tanezumab | Number of Participants With Anti-Drug Antibody (ADA) | Week 2 | 0 Participants |
| Tanezumab | Number of Participants With Anti-Drug Antibody (ADA) | Week 6 | 0 Participants |
| Tanezumab | Number of Participants With Anti-Drug Antibody (ADA) | Week 16 | 0 Participants |
Secondary
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
Population: Safety analysis set included all randomized participants who had received at least 1 dose of study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tanezumab | Number of Participants With Clinically Significant Neurological Examination Abnormalities | 3 Participants |
| Placebo | Number of Participants With Clinically Significant Neurological Examination Abnormalities | 1 Participants |
Secondary
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
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanezumab | Number of Participants With Global Response Assessment (GRA) | Week 6: Markedly Worse | 0 Participants |
| Tanezumab | Number of Participants With Global Response Assessment (GRA) | Week 6: Moderately Worse | 2 Participants |
| Tanezumab | Number of Participants With Global Response Assessment (GRA) | Week 6: Slightly Worse | 1 Participants |
| Tanezumab | Number of Participants With Global Response Assessment (GRA) | Week 6: No Change | 6 Participants |
| Tanezumab | Number of Participants With Global Response Assessment (GRA) | Week 6: Slightly Improved | 10 Participants |
| Tanezumab | Number of Participants With Global Response Assessment (GRA) | Week 6: Moderately Improved | 3 Participants |
| Tanezumab | Number of Participants With Global Response Assessment (GRA) | Week 6: Markedly Improved | 3 Participants |
| Tanezumab | Number of Participants With Global Response Assessment (GRA) | Week 16: Markedly Worse | 0 Participants |
| Tanezumab | Number of Participants With Global Response Assessment (GRA) | Week 16: Moderately Worse | 0 Participants |
| Tanezumab | Number of Participants With Global Response Assessment (GRA) | Week 16: Slightly Worse | 1 Participants |
| Tanezumab | Number of Participants With Global Response Assessment (GRA) | Week 16: No Change | 9 Participants |
| Tanezumab | Number of Participants With Global Response Assessment (GRA) | Week 16: Slightly Improved | 8 Participants |
| Tanezumab | Number of Participants With Global Response Assessment (GRA) | Week 16: Moderately Improved | 4 Participants |
| Tanezumab | Number of Participants With Global Response Assessment (GRA) | Week 16: Markedly Improved | 1 Participants |
| Placebo | Number of Participants With Global Response Assessment (GRA) | Week 16: No Change | 8 Participants |
| Placebo | Number of Participants With Global Response Assessment (GRA) | Week 6: Markedly Worse | 1 Participants |
| Placebo | Number of Participants With Global Response Assessment (GRA) | Week 16: Markedly Worse | 0 Participants |
| Placebo | Number of Participants With Global Response Assessment (GRA) | Week 6: Moderately Worse | 1 Participants |
| Placebo | Number of Participants With Global Response Assessment (GRA) | Week 16: Moderately Improved | 6 Participants |
| Placebo | Number of Participants With Global Response Assessment (GRA) | Week 6: Slightly Worse | 0 Participants |
| Placebo | Number of Participants With Global Response Assessment (GRA) | Week 16: Moderately Worse | 0 Participants |
| Placebo | Number of Participants With Global Response Assessment (GRA) | Week 6: No Change | 11 Participants |
| Placebo | Number of Participants With Global Response Assessment (GRA) | Week 16: Slightly Improved | 6 Participants |
| Placebo | Number of Participants With Global Response Assessment (GRA) | Week 6: Slightly Improved | 7 Participants |
| Placebo | Number of Participants With Global Response Assessment (GRA) | Week 16: Slightly Worse | 0 Participants |
| Placebo | Number of Participants With Global Response Assessment (GRA) | Week 6: Moderately Improved | 5 Participants |
| Placebo | Number of Participants With Global Response Assessment (GRA) | Week 16: Markedly Improved | 1 Participants |
| Placebo | Number of Participants With Global Response Assessment (GRA) | Week 6: Markedly Improved | 1 Participants |
Comparison: Week 6: Logistic regression model with age, baseline pain stratification group and treatment as covariates.90% CI: [0.763, 4.407]
Comparison: Week 16: Logistic regression model with age, baseline pain stratification group and treatment as covariates.90% CI: [0.388, 2.575]
Secondary
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
Population: Safety analysis set included all randomized participants who had received at least 1 dose of study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanezumab | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 24 Participants |
| Tanezumab | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 1 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 21 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
Secondary
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
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanezumab | Participant Global Preference | Week 16: Lifestyle Interventions | 7 Participants |
| Tanezumab | Participant Global Preference | Week 6: Definitely Prefer Current Drug | 4 Participants |
| Tanezumab | Participant Global Preference | Week 16: Physical Therapies | 3 Participants |
| Tanezumab | Participant Global Preference | Week 6: Training Programs | 2 Participants |
| Tanezumab | Participant Global Preference | Week 16: Training Programs | 3 Participants |
| Tanezumab | Participant Global Preference | Week 6: Slight Preference for Current Drug | 7 Participants |
| Tanezumab | Participant Global Preference | Week 16: Drug treatment-taken by mouth | 17 Participants |
| Tanezumab | Participant Global Preference | Week 6: Surgery/other prostate procedure | 0 Participants |
| Tanezumab | Participant Global Preference | Week 16: Surgery/other prostate procedure | 1 Participants |
| Tanezumab | Participant Global Preference | Week 6: No Preference | 13 Participants |
| Tanezumab | Participant Global Preference | Week 16: No Treatment | 3 Participants |
| Tanezumab | Participant Global Preference | Week 6: Physical Therapies | 2 Participants |
| Tanezumab | Participant Global Preference | Week 16: Definitely Prefer Current Drug | 9 Participants |
| Tanezumab | Participant Global Preference | Week 6: Slight Preference, Prior Treatment | 0 Participants |
| Tanezumab | Participant Global Preference | Week 16: Slight Preference for Current Drug | 4 Participants |
| Tanezumab | Participant Global Preference | Week 6: No Treatment | 6 Participants |
| Tanezumab | Participant Global Preference | Week 16: No Preference | 8 Participants |
| Tanezumab | Participant Global Preference | Week 6: Definitely Prefer Prior Treatment | 1 Participants |
| Tanezumab | Participant Global Preference | Week 16: Slight Preference, Prior Treatment | 0 Participants |
| Tanezumab | Participant Global Preference | Week 6:Drug treatment-taken by mouth | 19 Participants |
| Tanezumab | Participant Global Preference | Week 16: Definitely Prefer Prior Treatment | 2 Participants |
| Tanezumab | Participant Global Preference | Week 6: Lifestyle Interventions | 5 Participants |
| Placebo | Participant Global Preference | Week 16: Definitely Prefer Prior Treatment | 3 Participants |
| Placebo | Participant Global Preference | Week 6: Lifestyle Interventions | 5 Participants |
| Placebo | Participant Global Preference | Week 6: Physical Therapies | 4 Participants |
| Placebo | Participant Global Preference | Week 6: Training Programs | 0 Participants |
| Placebo | Participant Global Preference | Week 6:Drug treatment-taken by mouth | 14 Participants |
| Placebo | Participant Global Preference | Week 6: Surgery/other prostate procedure | 2 Participants |
| Placebo | Participant Global Preference | Week 6: No Treatment | 4 Participants |
| Placebo | Participant Global Preference | Week 6: Definitely Prefer Current Drug | 5 Participants |
| Placebo | Participant Global Preference | Week 6: Slight Preference for Current Drug | 5 Participants |
| Placebo | Participant Global Preference | Week 6: No Preference | 12 Participants |
| Placebo | Participant Global Preference | Week 6: Slight Preference, Prior Treatment | 0 Participants |
| Placebo | Participant Global Preference | Week 6: Definitely Prefer Prior Treatment | 2 Participants |
| Placebo | Participant Global Preference | Week 16: Lifestyle Interventions | 7 Participants |
| Placebo | Participant Global Preference | Week 16: Physical Therapies | 4 Participants |
| Placebo | Participant Global Preference | Week 16: Training Programs | 3 Participants |
| Placebo | Participant Global Preference | Week 16: Drug treatment-taken by mouth | 18 Participants |
| Placebo | Participant Global Preference | Week 16: Surgery/other prostate procedure | 0 Participants |
| Placebo | Participant Global Preference | Week 16: No Treatment | 1 Participants |
| Placebo | Participant Global Preference | Week 16: Definitely Prefer Current Drug | 8 Participants |
| Placebo | Participant Global Preference | Week 16: Slight Preference for Current Drug | 5 Participants |
| Placebo | Participant Global Preference | Week 16: No Preference | 6 Participants |
| Placebo | Participant Global Preference | Week 16: Slight Preference, Prior Treatment | 0 Participants |
Secondary
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
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanezumab | Patient Global Satisfaction Assessment | Week 6:Neither Satisfied nor Dissatisfied | 10 Participants |
| Tanezumab | Patient Global Satisfaction Assessment | Week 16: Extremely Satisfied | 4 Participants |
| Tanezumab | Patient Global Satisfaction Assessment | Week 6: Satisfied | 5 Participants |
| Tanezumab | Patient Global Satisfaction Assessment | Week 16: Satisfied | 7 Participants |
| Tanezumab | Patient Global Satisfaction Assessment | Week 6: Dissatisfied | 5 Participants |
| Tanezumab | Patient Global Satisfaction Assessment | Week16:Neither Satisfied nor Dissatisfied | 5 Participants |
| Tanezumab | Patient Global Satisfaction Assessment | Week 6: Extremely Satisfied | 3 Participants |
| Tanezumab | Patient Global Satisfaction Assessment | Week 16: Dissatisfied | 5 Participants |
| Tanezumab | Patient Global Satisfaction Assessment | Week 6: Extremely Dissatisfied | 2 Participants |
| Tanezumab | Patient Global Satisfaction Assessment | Week 16: Extremely Dissatisfied | 2 Participants |
| Placebo | Patient Global Satisfaction Assessment | Week 6: Extremely Dissatisfied | 3 Participants |
| Placebo | Patient Global Satisfaction Assessment | Week 6: Extremely Satisfied | 0 Participants |
| Placebo | Patient Global Satisfaction Assessment | Week 6: Satisfied | 5 Participants |
| Placebo | Patient Global Satisfaction Assessment | Week 6:Neither Satisfied nor Dissatisfied | 13 Participants |
| Placebo | Patient Global Satisfaction Assessment | Week 6: Dissatisfied | 3 Participants |
| Placebo | Patient Global Satisfaction Assessment | Week 16: Extremely Dissatisfied | 2 Participants |
| Placebo | Patient Global Satisfaction Assessment | Week 16: Extremely Satisfied | 1 Participants |
| Placebo | Patient Global Satisfaction Assessment | Week 16: Satisfied | 11 Participants |
| Placebo | Patient Global Satisfaction Assessment | Week16:Neither Satisfied nor Dissatisfied | 7 Participants |
| Placebo | Patient Global Satisfaction Assessment | Week 16: Dissatisfied | 1 Participants |
Secondary
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
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanezumab | Patient Willingness to Re-use Medicine | Week 6: Definitely Want | 6 Participants |
| Tanezumab | Patient Willingness to Re-use Medicine | Week 6: Might Want | 6 Participants |
| Tanezumab | Patient Willingness to Re-use Medicine | Week 6: Not Sure | 8 Participants |
| Tanezumab | Patient Willingness to Re-use Medicine | Week 6: Might not Want | 2 Participants |
| Tanezumab | Patient Willingness to Re-use Medicine | Week 6: Definitely Would not Want | 3 Participants |
| Tanezumab | Patient Willingness to Re-use Medicine | Week 16: Definitely Want | 10 Participants |
| Tanezumab | Patient Willingness to Re-use Medicine | Week 16: Might Want | 3 Participants |
| Tanezumab | Patient Willingness to Re-use Medicine | Week 16: Not Sure | 4 Participants |
| Tanezumab | Patient Willingness to Re-use Medicine | Week 16: Might not Want | 3 Participants |
| Tanezumab | Patient Willingness to Re-use Medicine | Week 16: Definitely Would not Want | 3 Participants |
| Placebo | Patient Willingness to Re-use Medicine | Week 16: Not Sure | 1 Participants |
| Placebo | Patient Willingness to Re-use Medicine | Week 6: Definitely Want | 8 Participants |
| Placebo | Patient Willingness to Re-use Medicine | Week 16: Definitely Want | 11 Participants |
| Placebo | Patient Willingness to Re-use Medicine | Week 6: Might Want | 4 Participants |
| Placebo | Patient Willingness to Re-use Medicine | Week 16: Definitely Would not Want | 3 Participants |
| Placebo | Patient Willingness to Re-use Medicine | Week 6: Not Sure | 9 Participants |
| Placebo | Patient Willingness to Re-use Medicine | Week 16: Might Want | 7 Participants |
| Placebo | Patient Willingness to Re-use Medicine | Week 6: Might not Want | 0 Participants |
| Placebo | Patient Willingness to Re-use Medicine | Week 16: Might not Want | 0 Participants |
| Placebo | Patient Willingness to Re-use Medicine | Week 6: Definitely Would not Want | 3 Participants |
Secondary
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tanezumab | Percentage of Participants Who Received Rescue Medication | Week 2 | 22 percentage of participants |
| Tanezumab | Percentage of Participants Who Received Rescue Medication | Week 4 | 17 percentage of participants |
| Tanezumab | Percentage of Participants Who Received Rescue Medication | Week 6 | 15 percentage of participants |
| Tanezumab | Percentage of Participants Who Received Rescue Medication | Week 8 | 14 percentage of participants |
| Tanezumab | Percentage of Participants Who Received Rescue Medication | Week 10 | 13 percentage of participants |
| Tanezumab | Percentage of Participants Who Received Rescue Medication | Week 16 | 12 percentage of participants |
| Placebo | Percentage of Participants Who Received Rescue Medication | Week 10 | 11 percentage of participants |
| Placebo | Percentage of Participants Who Received Rescue Medication | Week 2 | 19 percentage of participants |
| Placebo | Percentage of Participants Who Received Rescue Medication | Week 8 | 12 percentage of participants |
| Placebo | Percentage of Participants Who Received Rescue Medication | Week 4 | 17 percentage of participants |
| Placebo | Percentage of Participants Who Received Rescue Medication | Week 16 | 4 percentage of participants |
| Placebo | Percentage of Participants Who Received Rescue Medication | Week 6 | 16 percentage of participants |
Secondary
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Post-void Residual (PVR) Volume | Baseline | 34.1 milliliter | Standard Deviation 38.87 |
| Tanezumab | Post-void Residual (PVR) Volume | Week 2 | 19.6 milliliter | Standard Deviation 34.11 |
| Tanezumab | Post-void Residual (PVR) Volume | Week 6 | 31.4 milliliter | Standard Deviation 46.74 |
| Tanezumab | Post-void Residual (PVR) Volume | Week 16 | 26.4 milliliter | Standard Deviation 23.6 |
| Placebo | Post-void Residual (PVR) Volume | Week 16 | 22.5 milliliter | Standard Deviation 26.61 |
| Placebo | Post-void Residual (PVR) Volume | Baseline | 33.8 milliliter | Standard Deviation 40.87 |
| Placebo | Post-void Residual (PVR) Volume | Week 6 | 23.4 milliliter | Standard Deviation 41.38 |
| Placebo | Post-void Residual (PVR) Volume | Week 2 | 23.2 milliliter | Standard Deviation 36.18 |
Secondary
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Serum and Urine Nerve Growth Factor (NGF) Levels | Serum NGF: Week 2 | 2750 picogram per milliliter (pg/mL) | Standard Deviation 583 |
| Tanezumab | Serum and Urine Nerve Growth Factor (NGF) Levels | Serum NGF: Week 10 | 3840 picogram per milliliter (pg/mL) | Standard Deviation 925 |
| Tanezumab | Serum and Urine Nerve Growth Factor (NGF) Levels | Serum NGF: Week 6 | 3909 picogram per milliliter (pg/mL) | Standard Deviation 768 |
| Tanezumab | Serum and Urine Nerve Growth Factor (NGF) Levels | Serum NGF: Week 16 | 3025 picogram per milliliter (pg/mL) | Standard Deviation 1224 |
| Tanezumab | Serum and Urine Nerve Growth Factor (NGF) Levels | Serum NGF: Day 1 | 31.1 picogram per milliliter (pg/mL) | Standard Deviation 8.8 |
| Placebo | Serum and Urine Nerve Growth Factor (NGF) Levels | Serum NGF: Week 16 | 35.3 picogram per milliliter (pg/mL) | Standard Deviation 11 |
| Placebo | Serum and Urine Nerve Growth Factor (NGF) Levels | Serum NGF: Day 1 | 33.2 picogram per milliliter (pg/mL) | Standard Deviation 8.4 |
| Placebo | Serum and Urine Nerve Growth Factor (NGF) Levels | Serum NGF: Week 2 | 40.2 picogram per milliliter (pg/mL) | Standard Deviation 12.8 |
| Placebo | Serum and Urine Nerve Growth Factor (NGF) Levels | Serum NGF: Week 6 | 37.7 picogram per milliliter (pg/mL) | Standard Deviation 11 |
| Placebo | Serum and Urine Nerve Growth Factor (NGF) Levels | Serum NGF: Week 10 | 34.8 picogram per milliliter (pg/mL) | Standard Deviation 12.4 |