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

A PHASE 2, 16 WEEK, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED, PARALLEL GROUP PROOF-OF-CONCEPT STUDY EVALUATING THE EFFICACY AND SAFETY OF TANEZUMAB FOR THE TREATMENT OF PAIN ASSOCIATED WITH CHRONIC ABACTERIAL PROSTATITIS

The purpose of this study is to determine whether tanezumab is effective in the treatment of pain associated with chronic prostatitis.

Study Overview

• Status: Completed
• Conditions: Chronic Prostatitis With Chronic Pelvic Pain Syndrome
• Intervention / Treatment: Drug: Tanezumab; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2V 1P9
      • Prostate Cancer Centre / Urology Research
  • British Columbia
    • Victoria, British Columbia, Canada, V8T 5G1
      • Can-Med Clinical Research Inc.
    • Victoria, British Columbia, Canada, V8V 3N1
      • Dr. Steinhoff Clinical Research
    • Victoria, British Columbia, Canada, V8R 6T9
      • Office of Dr. Nazmuddin Merali
    • Victoria, British Columbia, Canada, V8T 5G1
      • PJ Pommerville Inc.
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0V9
      • Manitoba Prostate Centre
  • Ontario
    • Barrie, Ontario, Canada, L4M 7G1
      • The Male/Female Health and Research Centre
    • Kingston, Ontario, Canada, K7L 2V7
      • Kingston General Hospital
    • Kingston, Ontario, Canada, K7L 3J7
      • Centre for Applied Urological Research
    • Kitchener, Ontario, Canada, N2N 2B9
      • Urology Associates / Urologic Medical Research
    • Toronto, Ontario, Canada, M6A 3B5
      • The Male Health Centre
  • Quebec
    • Montreal, Quebec, Canada, H3A 1A1
      • Royal Victoria Hospital
• France
  • Lyon Cedex 03, France, 69437
    • Hopital Edouard Herriot
  • Nantes, France, 44000
    • Centre Hospitalier Universitaire de NANTES (CHU)
  • Nimes Cedex 9, France, 30029
    • CHU de Nîmes - Hôpital Carémeau
  • Paris, France, 75020
    • Hôpital Tenon
  • Paris cedex 12, France, 75571
    • Hôpital Rothschild
• Sweden
  • Lund, Sweden, 222 21
    • Capio Citykliniken AB
  • Skovde, Sweden, 541 85
    • Skaraborgs Sjukhus, FoU-centrum och urologkliniken
• Switzerland
  • Basel, Switzerland, CH-4031
    • Universitaetsspital Basel, Urologische Klinik
  • Bern, Switzerland, CH-3010
    • Klinik und Poliklinik fuer Urologie, Inselspital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • The Kirklin Clinic
    • Birmingham, Alabama, United States, 35209
      • Alabama Research Center, LLC
    • Birmingham, Alabama, United States, 35294-3411
      • University of Alabama Birmingham
  • Arizona
    • Goodyear, Arizona, United States, 85395
      • Valley Urologic Associates
    • Litchfield Park, Arizona, United States, 85340
      • Dedicated Clinical Research
  • California
    • Costa Mesa, California, United States, 92626
      • Clinical Innovations, Inc.
    • Glendora, California, United States, 91741
      • Citrus Valley Medical Research Inc.
    • Long Beach, California, United States, 90806
      • Atlantic Urological Medical Group Incorporated
    • Newport Beach, California, United States, 92663
      • Orange Coast Urology
    • Santa Monica, California, United States, 90404
      • Los Angeles Infertility and Prostatitis Medical Group
  • Florida
    • Bonita Springs, Florida, United States, 34134
      • Specialists in Urology
    • Naples, Florida, United States, 34102
      • Specialists in Urology
    • Saint Petersburg, Florida, United States, 33710
      • Pinellas Urology, Inc.
  • Louisiana
    • Shreveport, Louisiana, United States, 71106-8150
      • Regional Urology, LLC
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Quality Clinical Research
  • New York
    • Kingston, New York, United States, 12401
      • Hudson Valley Urology, PC
    • New York, New York, United States, 10016
      • University Urology Associates
    • Poughkeepsie, New York, United States, 12601
      • Hudson Valley Urology, PC
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • Tri-State Urologic Services PSC, Inc. dba The Urology Group
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University of The Commonwealth System of Higher Education
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • Volunteer Research Group
    • Knoxville, Tennessee, United States, 37920
      • University Urology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Intravenous placebo, single dose
Experimental: Tanezumab	Drug: Tanezumab; Intravenous, 20 mg, single dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Weeks 2, 4, 8, 10, and 16
Change From Baseline in Worst Daily Pain Score at Weeks 2, 4, 6, 8, 10, and 16	Participants assessed worst chronic prostatitis pain in the last 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 (no chronic prostatitis pain) to 10 (chronic prostatitis pain as bad as you can imagine). The worst daily pain score was calculated as the mean of the scores over the last 7 days prior to each assessment time point. Higher score indicated severe pain.	Baseline, Weeks 2, 4, 6, 8, 10, and 16
Change From Baseline in National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Overall and Sub-scale Score at Weeks 2, 4, 6, 8, 10, and 16	CPSI is a 9-item questionnaire, contains 3 modules that measure pain (question 1 to 4), urinary symptoms (question 5 and 6) and global quality of life (question 7 to 9). Total scores range from 0 to 21 on the pain module, 0 to 10 on the urinary symptoms and 0 to 12 on the quality of life module. NIH-CPSI total score (9-items) range from 0 to 43. Higher total and module scores indicate greater symptom severity and bother.	Baseline, Weeks 2, 4, 6, 8, 10, and 16
Change From Baseline in Number of Micturitions Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16	The micturition frequency per 24 hours was calculated from the sum of voluntary voids divided by the diary period over which they were collected.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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).	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.	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.	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.	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).	Day 1 (1 hour pre-dose), Weeks 2, 6, and 16

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2009
• Primary Completion (Actual): January 11, 2010
• Study Completion (Actual): March 17, 2010

Study Registration Dates

• First Submitted: January 21, 2009
• First Submitted That Met QC Criteria: January 21, 2009
• First Posted (Estimate): January 22, 2009

Study Record Updates

• Last Update Posted (Actual): May 13, 2021
• Last Update Submitted That Met QC Criteria: April 20, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Chronic Prostatis
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Prostatic Diseases; Pelvic Pain; Prostatitis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tanezumab
• Other Study ID Numbers: A4091019; 2008-004861-25 (EudraCT Number); PROSTATITIS POC (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.