An Efficacy And Safety Study Of Tanezumab For The Treatment Of Pain Associated With Chronic Abacterial Prostatitis
- Conditions
- Chronic Prostatitis With Chronic Pelvic Pain Syndrome
- Interventions
- Drug: Placebo
- Registration Number
- NCT00826514
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this study is to determine whether tanezumab is effective in the treatment of pain associated with chronic prostatitis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 62
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Tanezumab Tanezumab -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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 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 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.
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.
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 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.
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 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 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.
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 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).
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 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.
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.
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.
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).
Trial Locations
- Locations (42)
The Male Health Centre
🇨🇦Toronto, Ontario, Canada
Clinical Innovations, Inc.
🇺🇸Costa Mesa, California, United States
University Urology
🇺🇸Knoxville, Tennessee, United States
Quality Clinical Research
🇺🇸Omaha, Nebraska, United States
Universitaetsspital Basel, Urologische Klinik
🇨ðŸ‡Basel, Switzerland
Klinik und Poliklinik fuer Urologie, Inselspital
🇨ðŸ‡Bern, Switzerland
Hudson Valley Urology, PC
🇺🇸Poughkeepsie, New York, United States
Orange Coast Urology
🇺🇸Newport Beach, California, United States
University Urology Associates
🇺🇸New York, New York, United States
Valley Urologic Associates
🇺🇸Goodyear, Arizona, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Regional Urology, LLC
🇺🇸Shreveport, Louisiana, United States
Royal Victoria Hospital
🇨🇦Montreal, Quebec, Canada
Kingston General Hospital
🇨🇦Kingston, Ontario, Canada
Los Angeles Infertility and Prostatitis Medical Group
🇺🇸Santa Monica, California, United States
Temple University of the Commonwealth System of Higher Education
🇺🇸Philadelphia, Pennsylvania, United States
Manitoba Prostate Centre
🇨🇦Winnipeg, Manitoba, Canada
Dedicated Clinical Research
🇺🇸Litchfield Park, Arizona, United States
Citrus Valley Medical Research Inc.
🇺🇸Glendora, California, United States
Atlantic Urological Medical Group Incorporated
🇺🇸Long Beach, California, United States
Pinellas Urology, Inc.
🇺🇸Saint Petersburg, Florida, United States
Office of Dr. Nazmuddin Merali
🇨🇦Victoria, British Columbia, Canada
Volunteer Research Group
🇺🇸Knoxville, Tennessee, United States
Dr. Steinhoff Clinical Research
🇨🇦Victoria, British Columbia, Canada
PJ Pommerville Inc.
🇨🇦Victoria, British Columbia, Canada
Hopital Edouard Herriot
🇫🇷Lyon Cedex 03, France
Centre Hospitalier Universitaire de NANTES (CHU)
🇫🇷Nantes, France
Prostate Cancer Centre / Urology Research
🇨🇦Calgary, Alberta, Canada
Can-Med Clinical Research Inc.
🇨🇦Victoria, British Columbia, Canada
CHU de Nîmes - Hôpital CAREMEAU
🇫🇷Nimes Cedex 9, France
Hopital TENON
🇫🇷Paris, France
Alabama Research Center, LLC
🇺🇸Birmingham, Alabama, United States
The Kirklin Clinic
🇺🇸Birmingham, Alabama, United States
University of Alabama Birmingham
🇺🇸Birmingham, Alabama, United States
Tri-State Urologic Services PSC, Inc. dba The Urology Group
🇺🇸Cincinnati, Ohio, United States
Capio Citykliniken AB
🇸🇪Lund, Sweden
Centre for Applied Urological Research
🇨🇦Kingston, Ontario, Canada
Urology Associates / Urologic Medical Research
🇨🇦Kitchener, Ontario, Canada
Hopital Rothschild
🇫🇷Paris cedex 12, France
Skaraborgs Sjukhus, FoU-centrum och urologkliniken
🇸🇪Skovde, Sweden
Specialists in Urology
🇺🇸Naples, Florida, United States
The Male/Female Health and Research Centre
🇨🇦Barrie, Ontario, Canada