A Clinical Study to Investigate the Efficacy, Safety and Pharmacokinetics of ASP3652 in Patients With Chronic Abacterial Prostatitis / Chronic Pelvic Pain Syndrome (CP/CPPS)
- Conditions
- Chronic Abacterial ProstatitisChronic Pelvic Pain Syndrome
- Interventions
- Drug: Placebo
- Registration Number
- NCT01391338
- Lead Sponsor
- Astellas Pharma Inc
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 239
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lowest dose ASP3652 twice daily ASP3652 - Low dose ASP3652 twice daily ASP3652 - High dose ASP3652 twice daily ASP3652 - Placebo Placebo - Medium dose ASP3652 twice daily ASP3652 - High dose ASP3652 once daily ASP3652 -
- Primary Outcome Measures
Name Time Method 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
Name Time Method Male sexual health questionnaire at baseline and at 12 weeks Baseline and 12 weeks 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 12 weeks 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
Genitourinary pain index (GUPI) total score, sub domain and responders, at week 12 12 weeks Responder defined as 7 points or more decrease from baseline
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 Baseline, 4 weeks and 12 weeks treatment Based on daily urinary symptom diary for 3 consecutive days in the weeks prior to the visits at baseline, 4 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
Trial Locations
- Locations (49)
Site: 3701 - Hospital Moises Broggi de Sant Joa
🇪🇸Barcelona, Spain
Site: 3505 - EMC Instytut Medyczny SA
🇵🇱Wroclaw, Poland
Site: 3703 - Fundació Puigvert
🇪🇸Barcelona, Spain
Site: 3502 - Wojewodzki Szpital Specjalistyczny we Wroclawiu
🇵🇱Wroclaw, Poland
Site: 3504 - Centrum Medyczne Szpital Sw Rodziny Sp z o.o.
🇵🇱Lodz, Poland
Site: 3506 - Specjalistyczna Praktyka Lekarska Gabinet Urologiczny
🇵🇱Wroclaw, Poland
Site: 3205 - Gesundheitszentrum Holzminden
🇩🇪Holzminden, Germany
Site: 3702 - Hospital del Henares
🇪🇸Coslada, Spain
Site: 3105 - Fakultni nemocnice Hradec Kralove
🇨🇿Hradec Kralove, Czech Republic
Site: 3106 - Urologicke oddeleniUsti nad Labem
🇨🇿Kolin, Czech Republic
Site: 3103 - Fakultni nemocnice Olomouc
🇨🇿Olomouc, Czech Republic
Site: 3109- Hospital Kromeriz
🇨🇿Kromeriz, Czech Republic
Site: 3107 - Urologie
🇨🇿Novy Jicin, Czech Republic
Site: 3112 - Urosante
🇨🇿Praha, Czech Republic
Site: 3101- Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z.
🇨🇿Usti nad Labem, Czech Republic
Site: 3102 - Androgeos
🇨🇿Praha 6, Czech Republic
Site: 3104 - Uherskohradistska nemocnice a.s.
🇨🇿Uherske Hradiste, Czech Republic
Site: 3110 - Urologicka ordinace
🇨🇿Sternberk, Czech Republic
Site: 3211 - Urologische Gemeinschaftspraxis
🇩🇪Herzogenaurach, Germany
Site: 3212 - Urologische Praxis
🇩🇪Berlin, Germany
Site: 3214 - Charité Campus Benjamin Franklin
🇩🇪Berlin, Germany
Site: 3202 - Urologische Praxis
🇩🇪Buchholz, Germany
Site: 3206 - Private Praxis
🇩🇪Leipzig, Germany
Site: 3208 - Private Praxis Urologie Borken
🇩🇪Borken, Germany
Site: 3213 - Urologische Praxis
🇩🇪Kempen, Germany
Site: 3203 - Urologische Praxis
🇩🇪Hamburg, Germany
Site: 3201 - Universitats klinikum Giessen und Marburg
🇩🇪Giessen, Germany
Site: 3210 - Private Praxis
🇩🇪Marburg, Germany
Site: 3207 - Private Praxis
🇩🇪Markkleeberg, Germany
Site: 3204 - Akademisches Lehrkrankenhaus
🇩🇪Neunkirchen, Germany
Site: 3215 - Urologische Praxis
🇩🇪Reutlingen, Germany
Site: 3302 - Jelgava Outpatient Clinic
🇱🇻Jelgava, Latvia
Site: 3404 - Motina ir vaikas clinic
🇱🇹Kaunas, Lithuania
Site: 3209 - Private Praxis
🇩🇪Sangerhausen, Germany
Site: 3303 - P. Stradins Clinical University Hospital
🇱🇻Riga, Latvia
Site: 3304 - Nord Kurzeme Regional Hospital
🇱🇻Ventspils, Latvia
Site: 3402 - Vilnius Univeristy Hospital "Santariskiu Klinikos" Urology Centre
🇱🇹Vilnius, Lithuania
Site: 3301 - Litavniece Urologist Private Practice
🇱🇻Liepaja, Latvia
Site: 3503 - Urovita Sp.z.o.o. NZOZ Szpital Slaskie Centrum Urologii
🇵🇱Chorzow, Poland
Site: 3510 - Heureka Hanna Szalecka
🇵🇱Piaseczno, Poland
Site: 3401 - Clinics "Privatus gydytojas"
🇱🇹Vilnius, Lithuania
Site: 3403 - Public Institution Vilnius City University Hospital
🇱🇹Vilnius, Lithuania
Site: 3509 - NZOZ Nasz Lekarz, Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna
🇵🇱Lotum, Poland
Site: 3507 - Szpital Kliniczny Dzieciatka Jezus Centrum Leczenia Obrazen
🇵🇱Warszawa, Poland
Site: 3501 - Indywidualna Specjalistyczna Praktyka Lekarska
🇵🇱Poznan, Poland
Site: 3508 - NZOZ Centrum Medyczna Wola
🇵🇱Warszawa, Poland
Site: 3511 - Urologica Praktyka Lekarska Adam Marcheluk
🇵🇱Siedlce, Poland
Site: 3113 - Urologicka ambulance
🇨🇿Zatec, Czech Republic
Site: 3111 - Urology center
🇨🇿Plzen, Czech Republic