A Randomized Study comparing placebo and ASP3652 in the treatment of chronic prostatitis / chronic pelvic pain syndrome (CP/CPPS)

• Conditions: Chronic abacterial Prostatitis/Chronic Pelvic Pain Syndrome; MedDRA version: 14.1Level: LLTClassification code 10064189Term: Chronic pelvic pain syndromeSystem Organ Class: 100000004872; MedDRA version: 14.1Level: LLTClassification code 10009109Term: Chronic prostatitisSystem Organ Class: 100000004872; Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2010-023775-25-DE
• Lead Sponsor: Astellas Pharma Europe B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03-21
• Last Update Posted: 19 October 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 350

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified