Chronic Abacterial Prostatitis MedDRA version: 9.1 Level: LLT Classification code 10009109 Term: Chronic prostatitis
Conditions
Interventions
Product Name: Tanezumab
Pharmaceutical Form: Solution for infusion
CAS Number: 880266-57-9
Current Sponsor code: PF-04383119
Other descriptive name: RN624, RI624
Concentration unit: mg/ml milligram(s)
Sponsors
Pfizer Ltd., Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study: Assessment 1 (Screening). The following inclusion criteria have to be met in order for a subject to be randomized in this trial: 1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial. 2. Male outpatients aged =18 years. 3. Weight is =160 kg or a body mass index (BMI) of =39 kg/m2. 4. Clinical diagnosis of chronic abacterial prostatitis or chronic pelvic pain syndrome. 5. Moderate to severe chronic prostatitis at Screening as defined by: CPSI - Evidence of severity of CP - Total score =15 4-Glass Test - Type III prostatitis - No evidence of bacterial infection by standard microbiology within 2 years of screening An attempted 4-glass culture should have been performed within 2 years of Screening, with accompanying documentary evidence, or it will need to be repeated at Screening. If a urinary tract infection (UTI) has occurred in the period since the 4-glass culture was performed, then the 4-glass culture will need to be repeated again at Screening. It is recognized that it may not have been possible to collect both VB1 and VB2 or Expressed Prostatic Secretions (EPS). However, evidence must be available to categorize into types IIIa and IIIb chronic abacterial prostatitis. See also exclusion criterion #6, which excludes bacterial cystitis within 6 weeks. 6. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, the self-completion of study questionnaires and symptom diaries, and other trial procedures. 7. Male patients must agree that they and their female spouses / partners will use adequate contraception (2 forms of birth control, one of which must be a barrier method) or be of non-childbearing potential. They must be willing to use approved methods of contraception from commencement of screening procedures until 16 weeks after last dose of study medication. Assessment 2 (Randomization). The following continuation criteria have to be met in order for subjects to be randomized: 8. Completes at least 4 diary days during the 7 days prior to randomization, with a mean average pain intensity score of =4 (0-10 NRS); the mean average pain intensity score is defined as the mean of all 24 hr pain intensity scores recorded in the 7-day period prior to randomization Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects with symptoms of chronic prostatitis for less than 3 months of the last 6 months prior to Screening. 2. Subjects with a post-void residual (PVR) volume >200 mL at Screening. 3. Subjects with a mean total volume voided of >3000 mL per 24 hours, as confirmed by the diary completed prior to Randomization. 4. Subjects with greater than 1+ hematuria on dipstick test at Screening, unless fully investigated to rule out significant urological disease. 5. Subjects with a microbiologically-proven UTI, at Screening or Randomization. 6. Patients with urologic conditions that may result in symptoms that may be confused with chronic prostatitis eg Recurrent urinary tract infection. 7. Subjects with a history, evidence or suspicion of prostate cancer, unless previously excluded by biopsy. Those aged over 40 years with a Screening PSA =10, unless prostate cancer has previously been excluded by biopsy. 8. Patients using urinary catheters or who have undergone recent urologic procedures. 9. Patients commencing new bladder training or electrostimulation therapy regime. Established regimes may be continued provided they are not altered during the course of the study. 10. Taking other treatments for chronic prostatitis at Screening. 11. Use of any investigational medication within 30 days (or 5 x half life, whichever is longer) prior to the initial pain assessment period in the 7 days prior to randomization or plans to receive an investigational medication other than the study medication during the course of this study. 12. History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG-fusion protein or hypersensitivity to any ingredients of the formulation. 13. History of intolerance or hypersensitivity to paracetamol or any of its excipients or existence of a medical condition or use of concomitant medication for which the use of paracetamol is contraindicated (refer to product labeling). 14. Resting, sitting blood pressure (BP) =160 mm Hg in systolic pressure or =100 mm Hg in diastolic pressure at Screening. If a patient is found to have untreated significant hypertension at Screening and antihypertensive treatment is initiated, assessment for study eligibility should be deferred until BP and antihypertensive medication have been stable for at least one month. For patients with previously diagnosed hypertension, antihypertensive medications must be stable for at least 1 month prior to Screening. 15. Signs and symptoms of clinically significant cardiac disease in the 6 months prior to Screening. Patients with a history of heart block now controlled by a functioning cardiac pacemaker are eligible. 16. Subjects with a relevant neurological disease at Screening with which their CP symptoms may be associated (eg, Parkinson’s disease, spinal cord injury, spinal cord lesion, familial neuropathy, spina bifida or diabetic cystopathy); history, diagnosis, or signs and symptoms of clinically significant neurological disease. 17. Diagnosis of a transient ischemic attack in the 6 months prior to Screening, diagnosis of stroke with residual deficits (eg, aphasia, substantial motor or sensory deficits) that would preclude completion of required study activities. 18. History, diagnosis, signs or symptoms of any clinically significant psychiatric disorder. 19. Presence of drugs of abuse on urine drug screen, unless arising from medication that is medically indicated or prescribed by a physician. 20. Subjects with a his
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy, safety and tolerability of a single intravenous infusion of tanezumab in the treatment of pain associated with chronic prostatitis.;Secondary Objective: To evaluate the efficacy of a single dose of tanezumab in the treatment of other symptoms (eg, urinary urgency and frequency) associated with chronic prostatitis.;Primary end point(s): The primary endpoint is the change from Baseline to Week 6 in average daily pain as measured by an 11-point NRS derived from the daily diary. | — |
Countries
France, Sweden
Outcome results
None listed