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

简要总结

主要结局

次要结局

• Change From Baseline in Average Daily Pain Score at Weeks 2, 4, 8, 10, and 16(Baseline, Weeks 2, 4, 8, 10, and 16)
• 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)
• 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)
• 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)
• Participant Global Preference(Week 6 and 16)
• 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)
• 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)
• Number of Participants With Global Response Assessment (GRA)(Week 6 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(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(Baseline, Weeks 2, 4, 6, 8, 10, and 16)
• Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)(Baseline up to Week 16)
• Number of Participants With Anti-Drug Antibody (ADA)(Day 1 (1 hour pre-dose), Weeks 2, 6, and 16)
• 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)
• 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)
• Patient Global Satisfaction Assessment(Week 6 and 16)
• Number of Participants With Clinically Significant Neurological Examination Abnormalities(Baseline up to Week 16)
• Post-void Residual (PVR) Volume(Baseline, Weeks 2, 6, and 16)
• Patient Willingness to Re-use Medicine(Week 6 and 16)
• Percentage of Participants Who Received Rescue Medication(Weeks 2, 4, 6, 8, 10, and 16)
• Amount of Rescue Medication Taken(Weeks 2, 4, 6, 8, 10, and 16)
• Serum and Urine Nerve Growth Factor (NGF) Levels(Day 1 (1 hour pre-dose), Weeks 2, 6, 10, and 16)