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

Chronic Pelvic Pain Syndrome Clinical Trial

— AZURE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01391338
• Other study ID #: 3652-CL-0019
• Secondary ID: 2010-023775-25
• Status: Completed
• Phase: Phase 2
• First received: July 8, 2011
• Last updated: March 19, 2013
• Start date: June 2011
• Est. completion date: February 2013

Study information

• Verified date: March 2013
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug ControlGermany: Federal Institute for Drugs and Medical DevicesItaly: The Italian Medicines AgencyLatvia: State Agency of MedicinesLithuania: State Medicine Control Agency - Ministry of HealthPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 239
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Abacterial Prostatitis
• Chronic Pelvic Pain Syndrome
• Pelvic Pain
• Prostatitis

Intervention

Drug:
• ASP3652
Oral
• Placebo
Oral

Locations

Country	Name	City	State
Czech Republic	Site: 3105 - Fakultni nemocnice Hradec Kralove	Hradec Kralove
Czech Republic	Site: 3106 - Urologicke oddeleniUsti nad Labem	Kolin
Czech Republic	Site: 3109- Hospital Kromeriz	Kromeriz
Czech Republic	Site: 3107 - Urologie	Novy Jicin
Czech Republic	Site: 3103 - Fakultni nemocnice Olomouc	Olomouc
Czech Republic	Site: 3111 - Urology center	Plzen
Czech Republic	Site: 3112 - Urosante	Praha
Czech Republic	Site: 3102 - Androgeos	Praha 6
Czech Republic	Site: 3110 - Urologicka ordinace	Sternberk
Czech Republic	Site: 3104 - Uherskohradistska nemocnice a.s.	Uherske Hradiste
Czech Republic	Site: 3101- Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z.	Usti nad Labem
Czech Republic	Site: 3113 - Urologicka ambulance	Zatec
Germany	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
Latvia	Site: 3302 - Jelgava Outpatient Clinic	Jelgava
Latvia	Site: 3301 - Litavniece Urologist Private Practice	Liepaja
Latvia	Site: 3303 - P. Stradins Clinical University Hospital	Riga
Latvia	Site: 3304 - Nord Kurzeme Regional Hospital	Ventspils
Lithuania	Site: 3404 - Motina ir vaikas clinic	Kaunas
Lithuania	Site: 3401 - Clinics "Privatus gydytojas"	Vilnius
Lithuania	Site: 3402 - Vilnius Univeristy Hospital "Santariskiu Klinikos" Urology Centre	Vilnius
Lithuania	Site: 3403 - Public Institution Vilnius City University Hospital	Vilnius
Poland	Site: 3503 - Urovita Sp.z.o.o. NZOZ Szpital Slaskie Centrum Urologii	Chorzow
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: 3507 - Szpital Kliniczny Dzieciatka Jezus Centrum Leczenia Obrazen	Warszawa
Poland	Site: 3508 - NZOZ Centrum Medyczna Wola	Warszawa
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
Spain	Site: 3701 - Hospital Moises Broggi de Sant Joa	Barcelona
Spain	Site: 3703 - Fundació Puigvert	Barcelona
Spain	Site: 3702 - Hospital del Henares	Coslada

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

Czech Republic,  Germany,  Latvia,  Lithuania,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI), total score at 12 weeks		Baseline and 12 weeks	No
Secondary	Change from baseline in the NIH-CPSI pain domain score at week 12		Baseline and 12 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Short form McGill pain questionnaire: sensory, affective and total score, VAS, present pain intensity at baseline and at 12 weeks		Baseline and 12 weeks	No
Secondary	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	No
Secondary	International Prostate Symptom Score at screening and at 12 weeks		Screening and 12 weeks	No
Secondary	European Quality of Life questionnaire in 5 dimensions (EQ-5D) at baseline and at 12 weeks		Baseline and 12 weeks	No
Secondary	Male sexual health questionnaire at baseline and at 12 weeks		Baseline and 12 weeks	No