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

NCT01391338 | Completed Phase 2 DMC

• 2 other identifiers: 3652-CL-00192010-023775-25
• Study Type: interventional
• Target: 239
• Locations: 6 countries
• Sites: 49

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.

Conditions

Chronic Abacterial Prostatitis; Chronic Pelvic Pain Syndrome

Keywords

Prostatitis; Chronic; Pelvic Pain; NIH-CPSI; Pain domain score in NIH-CPSI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• 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

Study Arms (6)

Lowest dose ASP3652 twice daily

EXPERIMENTAL

Drug: ASP3652

Low dose ASP3652 twice daily

EXPERIMENTAL

Drug: ASP3652

Medium dose ASP3652 twice daily

EXPERIMENTAL

Drug: ASP3652

High dose ASP3652 once daily

EXPERIMENTAL

Drug: ASP3652

High dose ASP3652 twice daily

EXPERIMENTAL

Drug: ASP3652

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ASP3652 DRUG

Oral

High dose ASP3652 once daily; High dose ASP3652 twice daily; Low dose ASP3652 twice daily; Lowest dose ASP3652 twice daily; Medium dose ASP3652 twice daily

Placebo DRUG

Oral

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (49)

Site: 3105 - Fakultni nemocnice Hradec Kralove

Hradec Králové, 50005, Czechia

Location

Site: 3106 - Urologicke oddeleniUsti nad Labem

Kolín, 28000, Czechia

Location

Site: 3109- Hospital Kromeriz

Kroměříž, 76755, Czechia

Location

Site: 3107 - Urologie

Nový Jičín, 74101, Czechia

Location

Site: 3103 - Fakultni nemocnice Olomouc

Olomouc, 77200, Czechia

Location

Site: 3111 - Urology center

Pilsen, 30100, Czechia

Location

Site: 3112 - Urosante

Prague, 14000, Czechia

Location

Site: 3102 - Androgeos

Prague, 16000, Czechia

Location

Site: 3110 - Urologicka ordinace

Sternberk, 78501, Czechia

Location

Site: 3104 - Uherskohradistska nemocnice a.s.

Uherské Hradiště, 68668, Czechia

Location

Site: 3101- Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z.

Ústí nad Labem, 40113, Czechia

Location

Site: 3113 - Urologicka ambulance

Žatec, 43801, Czechia

Location

Site: 3212 - Urologische Praxis

Berlin, 10719, Germany

Location

Site: 3214 - Charité Campus Benjamin Franklin

Berlin, 12200, Germany

Location

Site: 3208 - Private Praxis Urologie Borken

Borken, 46325, Germany

Location

Site: 3202 - Urologische Praxis

Buchholz, 21244, Germany

Location

Site: 3201 - Universitats klinikum Giessen und Marburg

Giessen, 35392, Germany

Location

Site: 3203 - Urologische Praxis

Hamburg, 22587, Germany

Location

Site: 3211 - Urologische Gemeinschaftspraxis

Herzogenaurach, 91074, Germany

Location

Site: 3205 - Gesundheitszentrum Holzminden

Holzminden, 37603, Germany

Location

Site: 3213 - Urologische Praxis

Kempen, 47906, Germany

Location

Site: 3206 - Private Praxis

Leipzig, 04179, Germany

Location

Site: 3210 - Private Praxis

Marburg, 35039, Germany

Location

Site: 3207 - Private Praxis

Markkleeberg, 04416, Germany

Location

Site: 3204 - Akademisches Lehrkrankenhaus

Neunkirchen, 66538, Germany

Location

Site: 3215 - Urologische Praxis

Reutlingen, 72764, Germany

Location

Site: 3209 - Private Praxis

Sangerhausen, 06526, Germany

Location

Site: 3302 - Jelgava Outpatient Clinic

Jelgava, LV-3001, Latvia

Location

Site: 3301 - Litavniece Urologist Private Practice

Liepāja, LV-3401, Latvia

Location

Site: 3303 - P. Stradins Clinical University Hospital

Riga, LV-1002, Latvia

Location

Site: 3304 - Nord Kurzeme Regional Hospital

Ventspils, LV-3601, Latvia

Location

Site: 3404 - Motina ir vaikas clinic

Kaunas, LT-50154, Lithuania

Location

Site: 3402 - Vilnius Univeristy Hospital "Santariskiu Klinikos" Urology Centre

Vilnius, LT-08661, Lithuania

Location

Site: 3401 - Clinics "Privatus gydytojas"

Vilnius, LT-09108, Lithuania

Location

Site: 3403 - Public Institution Vilnius City University Hospital

Vilnius, LT-10207, Lithuania

Location

Site: 3503 - Urovita Sp.z.o.o. NZOZ Szpital Slaskie Centrum Urologii

Chorzów, 41-500, Poland

Location

Site: 3504 - Centrum Medyczne Szpital Sw Rodziny Sp z o.o.

Lodz, 90-302, Poland

Location

Site: 3509 - NZOZ Nasz Lekarz, Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna

Lotum, 87-100, Poland

Location

Site: 3510 - Heureka Hanna Szalecka

Piaseczno, 05-500, Poland

Location

Site: 3501 - Indywidualna Specjalistyczna Praktyka Lekarska

Poznan, 61-397, Poland

Location

Site: 3511 - Urologica Praktyka Lekarska Adam Marcheluk

Siedlce, 08-110, Poland

Location

Site: 3508 - NZOZ Centrum Medyczna Wola

Warsaw, 01-432, Poland

Location

Site: 3507 - Szpital Kliniczny Dzieciatka Jezus Centrum Leczenia Obrazen

Warsaw, 02-005, Poland

Location

Site: 3502 - Wojewodzki Szpital Specjalistyczny we Wroclawiu

Wroclaw, 51-124, Poland

Location

Site: 3505 - EMC Instytut Medyczny SA

Wroclaw, 54-144, Poland

Location

Site: 3506 - Specjalistyczna Praktyka Lekarska Gabinet Urologiczny

Wroclaw, 54-239, Poland

Location

Site: 3701 - Hospital Moises Broggi de Sant Joa

Barcelona, 8970, Spain

Location

Site: 3703 - Fundació Puigvert

Barcelona, CP: 08025, Spain

Location

Site: 3702 - Hospital del Henares

Coslada, CP:28822, Spain

Location

Related Publications (1)

• 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.

  PMID: 30178528 DERIVED

MeSH Terms

Conditions

Prostatitis; Bronchiolitis Obliterans Syndrome; Pelvic Pain

Interventions

ASP3652

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Executive Director Global Medical Science

  Astellas Pharma Europe B.V.

  STUDY DIRECTOR

• Coordination Investigator

  Clinic for Urology, Pediatric Urology and Andrology, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2011
• First Posted: July 12, 2011
• Study Start: June 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: March 21, 2013

Record last verified: 2013-03

Locations

LA (4); DE (15); CZ (12); PL (11); LI (4); ES (3)