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

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