Chronic abacterial Prostatitis/Chronic Pelvic Pain Syndrome MedDRA version: 14.1 Level: LLT Classification code 10064189 Term: Chronic pelvic pain syndrome System Organ Class: 100000004872 MedDRA version: 14.1 Level: LLT Classification code 10009109 Term: Chronic prostatitis System Organ Class: 100000004872
Conditions
Interventions
Product Name: ASP3652
Product Code: ASP3652
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: -
CAS Number: -
Current Sponsor code: ASP3652
Other descriptive name: -
Concentration unit: mg
Sponsors
Astellas Pharma Europe B.V.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: At screening (Visit 1), the subject must: 1. have signed the informed consent 2. be male and 18 years of age or older 3. be diagnosed with CP/CPPS with moderate to severe disease activity (NIH-CPSI: total =15, question 4 =4) 4. symptoms arising from prostate or surrounding tissues/non-prostate structures (pain on palpations and “Yes” to at least 1 item from NIH-CPSI question 1 and 2) At randomization (Visit 2), moderate/severe disease activity has to be confirmed 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: At screening (Visit 1), the subject must not have any of the following: 1. isolated unilateral testicular, penile or scrotal pain 2. urinary tract infection in the last 3 months before screening 3. any prior prostate and/or bladder intervention 3 months before screening 4. current urologic pathology; i.e., symptomatic urethral stricture, symptomatic bladder or ureteral calculi, lower urinary tract malignancy, severe bladder outlet obstruction, overactive bladder with incontinence, significant post void residual volume, clinically significant abnormalities on trans-abdominal ultrasound of bladder and prostate and/or neurologic disorder affecting bladder function 7. currently active sexually transmittable disease 8. history of, or known inflammatory bowel disease 9. severe fibromyalgia, severe irritable bowel syndrome and/or severe chronic fatigue syndrome 10. severe constipation and/or diarrhea, active diverticulitis and/or uninvestigated gastrointestinal bleeding substance abuse (incl. alcohol), any use of THC / positive urine test for THC
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate efficacy of ASP3652 in subjects with CP/CPPS, i.e., obtain proof of concept.;Secondary Objective: - To assess the optimal dose of ASP3652 for treatment of subjects with CP/CPPS. - To investigate safety and tolerability of ASP3652 in subjects with CP/CPPS. - To investigate pharmacokinetics and pharmacodynamics of ASP3652 in subjects with CP/CPPS.;Primary end point(s): The change from baseline in NIH-CPSI total score at 12 weeks of treatment (EoT).;Timepoint(s) of evaluation of this end point: (Week -2), Week 0, week 4, week 8, week 12, (week 16) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The change from baseline in the NIH-CPSI pain domain (i.e., the combined score for questions 1 – 4) at week 12 (i.e., Visit 6);Timepoint(s) of evaluation of this end point: (Week -2), Week 0, week 4, week 8, week 12, (week 16) | — |
Countries
Czech Republic, Germany, Latvia, Lithuania, Poland, Spain, United Kingdom
Contacts
Public ContactService Desk
Astellas Pharma Europe B.V.
Outcome results
None listed