A Clinical Study to Investigate the Efficacy, Safety and Pharmacokinetics of ASP3652 in Patients With Chronic Abacterial Prostatitis / Chronic Pelvic Pain Syndrome (CP/CPPS)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase II, Randomized, Double-blind, Placebo-controlled, Parallel Group, Adaptive, Combined Proof of Concept and Dose-Finding Study to Investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP3652 in the Treatment of CP/CPPS

Conditions
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Chronic Abacterial Prostatitis, Chronic Pelvic Pain Syndrome

Intervention / Treatment
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* Drug: ASP3652
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 for THC at screening Major depression, i.e. a Center for Epidemiological Studies Depression Scale score of 27 or more Any clinically relevant concomitant disease (past or present) which would, in the opinion of the investigator, put the subject at risk or mask measures of efficacy Use of steroids, immunomodulators, anticonvulsants, cytochrome P4502C8 inhibitors, cannabis/THC based medication, opioid analgetics or antiviral/antimicrobial/antifungal agents during the last 4 weeks before screening Initiation, discontinuation, or variation in the dose of antidepressants, alpha-blockers, 5-alpha reductase inhibitors, antimuscarinics, benzodiazepines, skeletal muscle relaxants, non-steroidal antiinflammatory drugs, non-opioid analgetics and herbal therapies during the last 4 weeks before screening. Subjects should continue these medications at that same stable dose throughout the study Clinically relevant abnormal urine or blood safety laboratory values or active hepatic and/or biliary disease (AST or ALT should not be >3 times the upper limit of normal, total bilirubin should not be >2 times the upper limit of normal) Participated in any clinical study or has been treated with any investigational drug or device within 30 days prior to screening, or the period stipulated by local regulations, whichever is longer

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lowest dose ASP3652 twice daily<br> | Drug: ASP3652<br>* Oral<br>|
| Experimental: Low dose ASP3652 twice daily<br> | Drug: ASP3652<br>* Oral<br>|
| Experimental: Medium dose ASP3652 twice daily<br> | Drug: ASP3652<br>* Oral<br>|
| Experimental: High dose ASP3652 once daily<br> | Drug: ASP3652<br>* Oral<br>|
| Experimental: High dose ASP3652 twice daily<br> | Drug: ASP3652<br>* Oral<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI), total score at 12 weeks |  | Baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the NIH-CPSI pain domain score at week 12 |  | 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 |  | 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 |  | 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 |  | 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 |  | 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 |  | 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 | 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 | 12 weeks | 
| Mean daily CPSI-24hour total score at baseline and at 4, 8 and 12 weeks and 2 weeks follow-up post treatment |  | 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 |  | 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 |  | 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 | Baseline, 4 weeks and 12 weeks treatment | 
| International Prostate Symptom Score at screening and at 12 weeks |  | Screening and 12 weeks | 
| European Quality of Life questionnaire in 5 dimensions (EQ-5D) at baseline and at 12 weeks |  | Baseline and 12 weeks | 
| Male sexual health questionnaire at baseline and at 12 weeks |  | Baseline and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostatitis, Chronic, Pelvic Pain, NIH-CPSI, Pain domain score in NIH-CPSI