Clinical trial NCT01391338: A Clinical Study to Investigate the Efficacy, Safety and Pharmacokinetics of ASP3652 in Patients With Chronic Abacterial Prostatitis / Chronic Pelvic Pain Syndrome (CP/CPPS)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Abacterial Prostatitis
Chronic Pelvic Pain Syndrome
Keywords: Prostatitis
Chronic
Pelvic Pain
NIH-CPSI
Pain domain score in NIH-CPSI
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2011-07-12
Enrollment: 239
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI), total score at 12 weeks
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change from baseline in the NIH-CPSI pain domain score at week 12
timeFrame: Baseline and 12 weeks
measure: Change from baseline in NIH-CPSI total score at 4 and 8 weeks and at 2 weeks follow-up after treatment
timeFrame: Baseline, 4 weeks, 8 weeks and 2 weeks follow-up post treatment
measure: Change from baseline in NIH-CPSI pain domain at week 4 and 8 and at 2 weeks follow-up after treatment
timeFrame: Baseline, 4 weeks, 8 weeks 2 weeks follow-up post treatment
measure: Change from baseline in NIH-CPSI urinary symptoms domain at week 4, 8 and 12 and at 2 weeks follow-up after treatment
timeFrame: Baseline, 4 weeks, 8 weeks and 12 weeks treatment and weeks 2 weeks follow-up post treatment
measure: 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
timeFrame: Baseline, 4 weeks, 8 weeks and 12 weeks treatment and weeks 2 weeks follow-up post treatment
measure: Global Response Assessment at week 4, 8 and 12 and at 2 weeks follow-up post treatment
timeFrame: Baseline, 4 weeks, 8 weeks and 12 weeks treatment and at 2 weeks follow-up post treatment
measure: The proportion of Clinical Responders
timeFrame: 12 weeks
measure: Genitourinary pain index (GUPI) total score, sub domain and responders, at week 12
timeFrame: 12 weeks
measure: Mean daily CPSI-24hour total score at baseline and at 4, 8 and 12 weeks and 2 weeks follow-up post treatment
timeFrame: Baseline, 4 weeks, 8 weeks and 12 weeks and 2 weeks follow-up post treatment
measure: 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
timeFrame: Baseline, 4 weeks, 8 weeks and 12 weeks and 2 weeks follow-up post treatment
measure: Short form McGill pain questionnaire: sensory, affective and total score, VAS, present pain intensity at baseline and at 12 weeks
timeFrame: Baseline and 12 weeks
measure: 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
timeFrame: Baseline, 4 weeks and 12 weeks treatment
measure: International Prostate Symptom Score at screening and at 12 weeks
timeFrame: Screening and 12 weeks
measure: European Quality of Life questionnaire in 5 dimensions (EQ-5D) at baseline and at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Male sexual health questionnaire at baseline and at 12 weeks
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Hradec Kralove
country: Czech Republic
facility: Site: 3105 - Fakultni nemocnice Hradec Kralove
city: Kolin
country: Czech Republic
facility: Site: 3106 - Urologicke oddeleniUsti nad Labem
city: Kromeriz
country: Czech Republic
facility: Site: 3109- Hospital Kromeriz
city: Novy Jicin
country: Czech Republic
facility: Site: 3107 - Urologie
city: Olomouc
country: Czech Republic
facility: Site: 3103 - Fakultni nemocnice Olomouc
city: Plzen
country: Czech Republic
facility: Site: 3111 - Urology center
city: Praha 6
country: Czech Republic
facility: Site: 3102 - Androgeos
city: Praha
country: Czech Republic
facility: Site: 3112 - Urosante
city: Sternberk
country: Czech Republic
facility: Site: 3110 - Urologicka ordinace
city: Uherske Hradiste
country: Czech Republic
facility: Site: 3104 - Uherskohradistska nemocnice a.s.
city: Usti nad Labem
country: Czech Republic
facility: Site: 3101- Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z.
city: Zatec
country: Czech Republic
facility: Site: 3113 - Urologicka ambulance
city: Berlin
country: Germany
facility: Site: 3212 - Urologische Praxis
city: Berlin
country: Germany
facility: Site: 3214 - Charité Campus Benjamin Franklin
city: Borken
country: Germany
facility: Site: 3208 - Private Praxis Urologie Borken
city: Buchholz
country: Germany
facility: Site: 3202 - Urologische Praxis
city: Giessen
country: Germany
facility: Site: 3201 - Universitats klinikum Giessen und Marburg
city: Hamburg
country: Germany
facility: Site: 3203 - Urologische Praxis
city: Herzogenaurach
country: Germany
facility: Site: 3211 - Urologische Gemeinschaftspraxis
city: Holzminden
country: Germany
facility: Site: 3205 - Gesundheitszentrum Holzminden
city: Kempen
country: Germany
facility: Site: 3213 - Urologische Praxis
city: Leipzig
country: Germany
facility: Site: 3206 - Private Praxis
city: Marburg
country: Germany
facility: Site: 3210 - Private Praxis
city: Markkleeberg
country: Germany
facility: Site: 3207 - Private Praxis
city: Neunkirchen
country: Germany
facility: Site: 3204 - Akademisches Lehrkrankenhaus
city: Reutlingen
country: Germany
facility: Site: 3215 - Urologische Praxis
city: Sangerhausen
country: Germany
facility: Site: 3209 - Private Praxis
city: Jelgava
country: Latvia
facility: Site: 3302 - Jelgava Outpatient Clinic
city: Liepaja
country: Latvia
facility: Site: 3301 - Litavniece Urologist Private Practice
city: Riga
country: Latvia
facility: Site: 3303 - P. Stradins Clinical University Hospital
city: Ventspils
country: Latvia
facility: Site: 3304 - Nord Kurzeme Regional Hospital
city: Kaunas
country: Lithuania
facility: Site: 3404 - Motina ir vaikas clinic
city: Vilnius
country: Lithuania
facility: Site: 3402 - Vilnius Univeristy Hospital "Santariskiu Klinikos" Urology Centre
city: Vilnius
country: Lithuania
facility: Site: 3401 - Clinics "Privatus gydytojas"
city: Vilnius
country: Lithuania
facility: Site: 3403 - Public Institution Vilnius City University Hospital
city: Chorzow
country: Poland
facility: Site: 3503 - Urovita Sp.z.o.o. NZOZ Szpital Slaskie Centrum Urologii
city: Lodz
country: Poland
facility: Site: 3504 - Centrum Medyczne Szpital Sw Rodziny Sp z o.o.
city: Lotum
country: Poland
facility: Site: 3509 - NZOZ Nasz Lekarz, Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna
city: Piaseczno
country: Poland
facility: Site: 3510 - Heureka Hanna Szalecka
city: Poznan
country: Poland
facility: Site: 3501 - Indywidualna Specjalistyczna Praktyka Lekarska
city: Siedlce
country: Poland
facility: Site: 3511 - Urologica Praktyka Lekarska Adam Marcheluk
city: Warszawa
country: Poland
facility: Site: 3508 - NZOZ Centrum Medyczna Wola
city: Warszawa
country: Poland
facility: Site: 3507 - Szpital Kliniczny Dzieciatka Jezus Centrum Leczenia Obrazen
city: Wroclaw
country: Poland
facility: Site: 3502 - Wojewodzki Szpital Specjalistyczny we Wroclawiu
city: Wroclaw
country: Poland
facility: Site: 3505 - EMC Instytut Medyczny SA
city: Wroclaw
country: Poland
facility: Site: 3506 - Specjalistyczna Praktyka Lekarska Gabinet Urologiczny
city: Barcelona
country: Spain
facility: Site: 3701 - Hospital Moises Broggi de Sant Joa
city: Barcelona
country: Spain
facility: Site: 3703 - Fundació Puigvert
city: Coslada
country: Spain
facility: Site: 3702 - Hospital del Henares
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Executive Director Global Medical Science
role: STUDY_DIRECTOR
affiliation: Clinic for Urology, Pediatric Urology and Andrology, Germany
name: Coordination Investigator
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.