A Clinical Study to Investigate the Efficacy, Safety and Pharmacokinetics of ASP3652 in Patients … (NCT01391338) | Clinical Trial Compass
CompletedPhase 2
A Clinical Study to Investigate the Efficacy, Safety and Pharmacokinetics of ASP3652 in Patients With Chronic Abacterial Prostatitis / Chronic Pelvic Pain Syndrome (CP/CPPS)
Czechia239 participantsStarted 2011-06
Plain-language summary
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.
Who can participate
Age range18 Years
SexMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Is diagnosed with CP/CPPS with symptoms for at least 3 months over the last 6 months
* Has a NIH-CPSI total score of at least 15
* A score of at least 4 on question 4 (pain) in the NIH-CPSI
* Reports pain on palpation of the prostate or the perineum/genital area
* Answers "yes" to at least 1 out of 6 items in question 1 and 2 of the NIH-CPSI
* Is willing to comply with study requirements such as completing the micturition and symptoms diary and attend all study visits
Exclusion Criteria:
* Isolated unilateral testicular, penile or scrotal pain as a solitary symptom of pelvic pain
* Urinary Tract Infection (UTI) or prostate infection found at screening using the pre- and post massage test or in the last 3 months prior to screening
* Any prior prostate and or bladder intervention within 3 months prior to screening
* Lower urinary tract malignancy (suspected), such as positive (micro) hematuria in urine sediment or Prostate Specific Antigen (PSA) \>4 ng/mL
* Symptomatic urethral stricture or symptomatic bladder or urethral calculi, severe bladder outlet obstruction, overactive bladder with incontinence or Post Void Residual volume, greater than 150 mL
* Clinically significant abnormalities on transabdominal ultrasound of bladder and prostate or neurological disease or defect affecting bladder function
* Currently active sexually transmittable disease
* Substance abuse or any use of delta-9-tetrahydrocannabinol (THC) as assessed by a positive urine test f…
What they're measuring
1
Change from baseline in the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI), total score at 12 weeks