In this study several doses of ASP3652, given orally for 12 weeks, will be compared with placebo in the treatment of patients with Chronic abacterial Prostatitis / Chronic Pelvic Pain Syndrome.
This study will investigate the efficacy of ASP3652 in the treatment of patients with Chronic abacterial Prostatitis / Chronic Pelvic Pain Syndrome (CP/CPPS). In comparison with placebo, ASP3652 will be given in different dosages orally for 12 weeks. The aims are to investigate efficacy of ASP3652 in CP/CPPS, to assess the optimal dose of ASP3652, to investigate safety and tolerability and to investigate pharmacokinetics and pharmacodynamics of ASP3652 in patients with CP/CPPS in and out-patients setting.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
239
Change from baseline in the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI), total score at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline in the NIH-CPSI pain domain score at week 12
Time frame: Baseline and 12 weeks
Change from baseline in NIH-CPSI total score at 4 and 8 weeks and at 2 weeks follow-up after treatment
Time frame: Baseline, 4 weeks, 8 weeks and 2 weeks follow-up post treatment
Change from baseline in NIH-CPSI pain domain at week 4 and 8 and at 2 weeks follow-up after treatment
Time frame: Baseline, 4 weeks, 8 weeks 2 weeks follow-up post treatment
Change from baseline in NIH-CPSI urinary symptoms domain at week 4, 8 and 12 and at 2 weeks follow-up after treatment
Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks treatment and weeks 2 weeks follow-up post treatment
Change from baseline in NIH-CPSI Quality of Life impact domain at week 4, 8 and 12 and at 2 weeks follow-up after treatment
Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks treatment and weeks 2 weeks follow-up post treatment
Global Response Assessment at week 4, 8 and 12 and at 2 weeks follow-up post treatment
Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks treatment and at 2 weeks follow-up post treatment
The proportion of Clinical Responders
Composite of two definitions are used: subjects who showed at least 4 points decrease in NIH-CPSI total score at 12 weeks compared to baseline and subjects who showed at least 6 points decrease in NIH-CPSI total score at 12 weeks
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Site: 3105 - Fakultni nemocnice Hradec Kralove
Hradec Králové, Czechia
Site: 3106 - Urologicke oddeleniUsti nad Labem
Kolín, Czechia
Site: 3109- Hospital Kromeriz
Kroměříž, Czechia
Site: 3107 - Urologie
Nový Jičín, Czechia
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Olomouc, Czechia
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Pilsen, Czechia
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Prague, Czechia
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Prague, Czechia
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Sternberk, Czechia
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Uherské Hradiště, Czechia
...and 39 more locations
Time frame: 12 weeks
Genitourinary pain index (GUPI) total score, sub domain and responders, at week 12
Responder defined as 7 points or more decrease from baseline
Time frame: 12 weeks
Mean daily CPSI-24hour total score at baseline and at 4, 8 and 12 weeks and 2 weeks follow-up post treatment
Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks and 2 weeks follow-up post treatment
Mean daily pain for the 7 days period prior to attending study visits at baseline and at 4, 8 and 12 weeks and 2 weeks follow-up post treatment
Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks and 2 weeks follow-up post treatment
Short form McGill pain questionnaire: sensory, affective and total score, VAS, present pain intensity at baseline and at 12 weeks
Time frame: Baseline and 12 weeks
Voiding: mean number of micturitions per 24 hours and per night, mean number of urgency episodes per 24 hours and mean level of urgency per micturition
Based on daily urinary symptom diary for 3 consecutive days in the weeks prior to the visits at baseline, 4 and 12 weeks treatment
Time frame: Baseline, 4 weeks and 12 weeks treatment
International Prostate Symptom Score at screening and at 12 weeks
Time frame: Screening and 12 weeks
European Quality of Life questionnaire in 5 dimensions (EQ-5D) at baseline and at 12 weeks
Time frame: Baseline and 12 weeks
Male sexual health questionnaire at baseline and at 12 weeks
Time frame: Baseline and 12 weeks