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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00826514
Other study ID # A4091019
Secondary ID 2008-004861-25PR
Status Completed
Phase Phase 2
First received
Last updated
Start date March 25, 2009
Est. completion date March 17, 2010

Study information

Verified date April 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date March 17, 2010
Est. primary completion date January 11, 2010
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Tanezumab
Intravenous, 20 mg, single dose.
Placebo
Intravenous placebo, single dose

Locations

Country Name City State
Canada The Male/Female Health and Research Centre Barrie Ontario
Canada Prostate Cancer Centre / Urology Research Calgary Alberta
Canada Centre for Applied Urological Research Kingston Ontario
Canada Kingston General Hospital Kingston Ontario
Canada Urology Associates / Urologic Medical Research Kitchener Ontario
Canada Royal Victoria Hospital Montreal Quebec
Canada The Male Health Centre Toronto Ontario
Canada Can-Med Clinical Research Inc. Victoria British Columbia
Canada Dr. Steinhoff Clinical Research Victoria British Columbia
Canada Office of Dr. Nazmuddin Merali Victoria British Columbia
Canada PJ Pommerville Inc. Victoria British Columbia
Canada Manitoba Prostate Centre Winnipeg Manitoba
France Hopital Edouard Herriot Lyon Cedex 03
France Centre Hospitalier Universitaire de NANTES (CHU) Nantes
France CHU de Nîmes - Hôpital CAREMEAU Nimes Cedex 9
France Hopital TENON Paris
France Hopital Rothschild Paris cedex 12
Sweden Capio Citykliniken AB Lund
Sweden Skaraborgs Sjukhus, FoU-centrum och urologkliniken Skovde
Switzerland Universitaetsspital Basel, Urologische Klinik Basel
Switzerland Klinik und Poliklinik fuer Urologie, Inselspital Bern
United States Alabama Research Center, LLC Birmingham Alabama
United States The Kirklin Clinic Birmingham Alabama
United States University of Alabama Birmingham Birmingham Alabama
United States Specialists in Urology Bonita Springs Florida
United States Tri-State Urologic Services PSC, Inc. dba The Urology Group Cincinnati Ohio
United States Cleveland Clinic Cleveland Ohio
United States Clinical Innovations, Inc. Costa Mesa California
United States Citrus Valley Medical Research Inc. Glendora California
United States Valley Urologic Associates Goodyear Arizona
United States Hudson Valley Urology, PC Kingston New York
United States University Urology Knoxville Tennessee
United States Volunteer Research Group Knoxville Tennessee
United States Dedicated Clinical Research Litchfield Park Arizona
United States Atlantic Urological Medical Group Incorporated Long Beach California
United States Specialists in Urology Naples Florida
United States University Urology Associates New York New York
United States Orange Coast Urology Newport Beach California
United States Quality Clinical Research Omaha Nebraska
United States Temple University of the Commonwealth System of Higher Education Philadelphia Pennsylvania
United States Hudson Valley Urology, PC Poughkeepsie New York
United States Pinellas Urology, Inc. Saint Petersburg Florida
United States Los Angeles Infertility and Prostatitis Medical Group Santa Monica California
United States Regional Urology, LLC Shreveport Louisiana

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada,  France,  Sweden,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
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. Baseline, Week 6
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. Baseline, Weeks 2, 4, 8, 10, and 16
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. Baseline, Weeks 2, 4, 6, 8, 10, and 16
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. Baseline, Weeks 2, 4, 6, 8, 10, and 16
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. Baseline, Week 2, 4, 6, 8, 10, and 16
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. Baseline, Weeks 2, 4, 6, 8, 10, and 16
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. Baseline, Weeks 2, 4, 6, 8, 10, and 16
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. Baseline, Weeks 2, 4, 6, 8, 10, and 16
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. Baseline, Weeks 2, 4, 6, 8, 10, and 16
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. Baseline, Weeks 2, 4, 6, 8, 10, and 16
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. Baseline, Weeks 2, 4, 6, 8, 10, and 16
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. Week 6 and 16
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. Week 6 and 16
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. Week 6 and 16
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. Week 6 and 16
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. Weeks 2, 4, 6, 8, 10, and 16
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. Weeks 2, 4, 6, 8, 10, and 16
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). Day 1 (1 hour pre-dose), Weeks 2, 6, 10, and 16
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. Baseline up to Week 16
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. Baseline up to Week 16
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. Baseline, Weeks 2, 6, and 16
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). Day 1 (1 hour pre-dose), Weeks 2, 6, and 16
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