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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023775-25 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lowest dose ASP3652 twice daily | Experimental |
| |
| Low dose ASP3652 twice daily | Experimental |
| |
| Medium dose ASP3652 twice daily | Experimental |
| |
| High dose ASP3652 once daily | Experimental |
| |
| High dose ASP3652 twice daily | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP3652 | Drug | Oral |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Executive Director Global Medical Science | Astellas Pharma Europe B.V. | Study Director |
| Coordination Investigator | Clinic for Urology, Pediatric Urology and Andrology, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site: 3105 - Fakultni nemocnice Hradec Kralove | Hradec Králové | 50005 | Czechia | |||
| Site: 3106 - Urologicke oddeleniUsti nad Labem |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30178528 | Derived | Martina R, Houbiers J, Melis J, van Till O. A combined proof of concept and dose finding study with multiple endpoints: A Bayesian adaptive design in chronic prostatitis/chronic pelvic pain syndrome. Biom J. 2019 May;61(3):476-487. doi: 10.1002/bimj.201700210. Epub 2018 Sep 3. |
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| Placebo | Drug | Oral |
|
| 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 |
| Kolín |
| 28000 |
| Czechia |
| Site: 3109- Hospital Kromeriz | Kroměříž | 76755 | Czechia |
| Site: 3107 - Urologie | Nový Jičín | 74101 | Czechia |
| Site: 3103 - Fakultni nemocnice Olomouc | Olomouc | 77200 | Czechia |
| Site: 3111 - Urology center | Pilsen | 30100 | Czechia |
| Site: 3112 - Urosante | Prague | 14000 | Czechia |
| Site: 3102 - Androgeos | Prague | 16000 | Czechia |
| Site: 3110 - Urologicka ordinace | Sternberk | 78501 | Czechia |
| Site: 3104 - Uherskohradistska nemocnice a.s. | Uherské Hradiště | 68668 | Czechia |
| Site: 3101- Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z. | Ústí nad Labem | 40113 | Czechia |
| Site: 3113 - Urologicka ambulance | Žatec | 43801 | Czechia |
| Site: 3212 - Urologische Praxis | Berlin | 10719 | Germany |
| Site: 3214 - Charité Campus Benjamin Franklin | Berlin | 12200 | Germany |
| Site: 3208 - Private Praxis Urologie Borken | Borken | 46325 | Germany |
| Site: 3202 - Urologische Praxis | Buchholz | 21244 | Germany |
| Site: 3201 - Universitats klinikum Giessen und Marburg | Giessen | 35392 | Germany |
| Site: 3203 - Urologische Praxis | Hamburg | 22587 | Germany |
| Site: 3211 - Urologische Gemeinschaftspraxis | Herzogenaurach | 91074 | Germany |
| Site: 3205 - Gesundheitszentrum Holzminden | Holzminden | 37603 | Germany |
| Site: 3213 - Urologische Praxis | Kempen | 47906 | Germany |
| Site: 3206 - Private Praxis | Leipzig | 04179 | Germany |
| Site: 3210 - Private Praxis | Marburg | 35039 | Germany |
| Site: 3207 - Private Praxis | Markkleeberg | 04416 | Germany |
| Site: 3204 - Akademisches Lehrkrankenhaus | Neunkirchen | 66538 | Germany |
| Site: 3215 - Urologische Praxis | Reutlingen | 72764 | Germany |
| Site: 3209 - Private Praxis | Sangerhausen | 06526 | Germany |
| Site: 3302 - Jelgava Outpatient Clinic | Jelgava | LV-3001 | Latvia |
| Site: 3301 - Litavniece Urologist Private Practice | Liepāja | LV-3401 | Latvia |
| Site: 3303 - P. Stradins Clinical University Hospital | Riga | LV-1002 | Latvia |
| Site: 3304 - Nord Kurzeme Regional Hospital | Ventspils | LV-3601 | Latvia |
| Site: 3404 - Motina ir vaikas clinic | Kaunas | LT-50154 | Lithuania |
| Site: 3402 - Vilnius Univeristy Hospital "Santariskiu Klinikos" Urology Centre | Vilnius | LT-08661 | Lithuania |
| Site: 3401 - Clinics "Privatus gydytojas" | Vilnius | LT-09108 | Lithuania |
| Site: 3403 - Public Institution Vilnius City University Hospital | Vilnius | LT-10207 | Lithuania |
| Site: 3503 - Urovita Sp.z.o.o. NZOZ Szpital Slaskie Centrum Urologii | Chorzów | 41-500 | Poland |
| Site: 3504 - Centrum Medyczne Szpital Sw Rodziny Sp z o.o. | Lodz | 90-302 | Poland |
| Site: 3509 - NZOZ Nasz Lekarz, Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna | Lotum | 87-100 | Poland |
| Site: 3510 - Heureka Hanna Szalecka | Piaseczno | 05-500 | Poland |
| Site: 3501 - Indywidualna Specjalistyczna Praktyka Lekarska | Poznan | 61-397 | Poland |
| Site: 3511 - Urologica Praktyka Lekarska Adam Marcheluk | Siedlce | 08-110 | Poland |
| Site: 3508 - NZOZ Centrum Medyczna Wola | Warsaw | 01-432 | Poland |
| Site: 3507 - Szpital Kliniczny Dzieciatka Jezus Centrum Leczenia Obrazen | Warsaw | 02-005 | Poland |
| Site: 3502 - Wojewodzki Szpital Specjalistyczny we Wroclawiu | Wroclaw | 51-124 | Poland |
| Site: 3505 - EMC Instytut Medyczny SA | Wroclaw | 54-144 | Poland |
| Site: 3506 - Specjalistyczna Praktyka Lekarska Gabinet Urologiczny | Wroclaw | 54-239 | Poland |
| Site: 3701 - Hospital Moises Broggi de Sant Joa | Barcelona | 8970 | Spain |
| Site: 3703 - Fundació Puigvert | Barcelona | CP: 08025 | Spain |
| Site: 3702 - Hospital del Henares | Coslada | CP:28822 | Spain |
| ID | Term |
|---|---|
| D011472 | Prostatitis |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D017699 | Pelvic Pain |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000719587 | ASP3652 |
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