A Clinical Study to Investigate the Efficacy, Safety and Pharmacokinetics of ASP3652 in Patients With Chronic Abacterial Prostatitis / Chronic Pelvic Pain Syndrome (CP/CPPS)
NCT ID: NCT01391338
Last Updated: 2013-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
239 participants
INTERVENTIONAL
2011-06-30
2013-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Lowest dose ASP3652 twice daily
ASP3652
Oral
Low dose ASP3652 twice daily
ASP3652
Oral
Medium dose ASP3652 twice daily
ASP3652
Oral
High dose ASP3652 once daily
ASP3652
Oral
High dose ASP3652 twice daily
ASP3652
Oral
Placebo
Placebo
Oral
Interventions
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ASP3652
Oral
Placebo
Oral
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Executive Director Global Medical Science
Role: STUDY_DIRECTOR
Astellas Pharma Europe B.V.
Coordination Investigator
Role: PRINCIPAL_INVESTIGATOR
Clinic for Urology, Pediatric Urology and Andrology, Germany
Locations
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Site: 3105 - Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
Site: 3106 - Urologicke oddeleniUsti nad Labem
Kolín, , Czechia
Site: 3109- Hospital Kromeriz
Kroměříž, , Czechia
Site: 3107 - Urologie
Nový Jičín, , Czechia
Site: 3103 - Fakultni nemocnice Olomouc
Olomouc, , Czechia
Site: 3111 - Urology center
Pilsen, , Czechia
Site: 3112 - Urosante
Prague, , Czechia
Site: 3102 - Androgeos
Prague, , Czechia
Site: 3110 - Urologicka ordinace
Sternberk, , Czechia
Site: 3104 - Uherskohradistska nemocnice a.s.
Uherské Hradiště, , Czechia
Site: 3101- Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z.
Ústí nad Labem, , Czechia
Site: 3113 - Urologicka ambulance
Žatec, , Czechia
Site: 3212 - Urologische Praxis
Berlin, , Germany
Site: 3214 - Charité Campus Benjamin Franklin
Berlin, , Germany
Site: 3208 - Private Praxis Urologie Borken
Borken, , Germany
Site: 3202 - Urologische Praxis
Buchholz, , Germany
Site: 3201 - Universitats klinikum Giessen und Marburg
Giessen, , Germany
Site: 3203 - Urologische Praxis
Hamburg, , Germany
Site: 3211 - Urologische Gemeinschaftspraxis
Herzogenaurach, , Germany
Site: 3205 - Gesundheitszentrum Holzminden
Holzminden, , Germany
Site: 3213 - Urologische Praxis
Kempen, , Germany
Site: 3206 - Private Praxis
Leipzig, , 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: 3209 - Private Praxis
Sangerhausen, , Germany
Site: 3302 - Jelgava Outpatient Clinic
Jelgava, , Latvia
Site: 3301 - Litavniece Urologist Private Practice
Liepāja, , Latvia
Site: 3303 - P. Stradins Clinical University Hospital
Riga, , Latvia
Site: 3304 - Nord Kurzeme Regional Hospital
Ventspils, , Latvia
Site: 3404 - Motina ir vaikas clinic
Kaunas, , Lithuania
Site: 3402 - Vilnius Univeristy Hospital "Santariskiu Klinikos" Urology Centre
Vilnius, , Lithuania
Site: 3401 - Clinics "Privatus gydytojas"
Vilnius, , Lithuania
Site: 3403 - Public Institution Vilnius City University Hospital
Vilnius, , Lithuania
Site: 3503 - Urovita Sp.z.o.o. NZOZ Szpital Slaskie Centrum Urologii
Chorzów, , Poland
Site: 3504 - Centrum Medyczne Szpital Sw Rodziny Sp z o.o.
Lodz, , Poland
Site: 3509 - NZOZ Nasz Lekarz, Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna
Lotum, , Poland
Site: 3510 - Heureka Hanna Szalecka
Piaseczno, , Poland
Site: 3501 - Indywidualna Specjalistyczna Praktyka Lekarska
Poznan, , Poland
Site: 3511 - Urologica Praktyka Lekarska Adam Marcheluk
Siedlce, , Poland
Site: 3508 - NZOZ Centrum Medyczna Wola
Warsaw, , Poland
Site: 3507 - Szpital Kliniczny Dzieciatka Jezus Centrum Leczenia Obrazen
Warsaw, , Poland
Site: 3502 - Wojewodzki Szpital Specjalistyczny we Wroclawiu
Wroclaw, , Poland
Site: 3505 - EMC Instytut Medyczny SA
Wroclaw, , Poland
Site: 3506 - Specjalistyczna Praktyka Lekarska Gabinet Urologiczny
Wroclaw, , Poland
Site: 3701 - Hospital Moises Broggi de Sant Joa
Barcelona, , Spain
Site: 3703 - Fundació Puigvert
Barcelona, , Spain
Site: 3702 - Hospital del Henares
Coslada, , Spain
Countries
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References
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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.
Other Identifiers
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2010-023775-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
3652-CL-0019
Identifier Type: -
Identifier Source: org_study_id
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