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

March 19, 2013 updated by: Astellas Pharma Inc

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
239

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Hradec Kralove, Czech Republic, 50005
        • Site: 3105 - Fakultni nemocnice Hradec Kralove
      • Kolin, Czech Republic, 28000
        • Site: 3106 - Urologicke oddeleniUsti nad Labem
      • Kromeriz, Czech Republic, 76755
        • Site: 3109- Hospital Kromeriz
      • Novy Jicin, Czech Republic, 74101
        • Site: 3107 - Urologie
      • Olomouc, Czech Republic, 77200
        • Site: 3103 - Fakultni nemocnice Olomouc
      • Plzen, Czech Republic, 30100
        • Site: 3111 - Urology center
      • Praha, Czech Republic, 14000
        • Site: 3112 - Urosante
      • Praha 6, Czech Republic, 16000
        • Site: 3102 - Androgeos
      • Sternberk, Czech Republic, 78501
        • Site: 3110 - Urologicka ordinace
      • Uherske Hradiste, Czech Republic, 68668
        • Site: 3104 - Uherskohradistska nemocnice a.s.
      • Usti nad Labem, Czech Republic, 40113
        • Site: 3101- Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z.
      • Zatec, Czech Republic, 43801
        • Site: 3113 - Urologicka ambulance
  • Germany
      • Berlin, Germany, 10719
        • Site: 3212 - Urologische Praxis
      • Berlin, Germany, 12200
        • Site: 3214 - Charité Campus Benjamin Franklin
      • Borken, Germany, 46325
        • Site: 3208 - Private Praxis Urologie Borken
      • Buchholz, Germany, 21244
        • Site: 3202 - Urologische Praxis
      • Giessen, Germany, 35392
        • Site: 3201 - Universitats klinikum Giessen und Marburg
      • Hamburg, Germany, 22587
        • Site: 3203 - Urologische Praxis
      • Herzogenaurach, Germany, 91074
        • Site: 3211 - Urologische Gemeinschaftspraxis
      • Holzminden, Germany, 37603
        • Site: 3205 - Gesundheitszentrum Holzminden
      • Kempen, Germany, 47906
        • Site: 3213 - Urologische Praxis
      • Leipzig, Germany, 04179
        • Site: 3206 - Private Praxis
      • Marburg, Germany, 35039
        • Site: 3210 - Private Praxis
      • Markkleeberg, Germany, 04416
        • Site: 3207 - Private Praxis
      • Neunkirchen, Germany, 66538
        • Site: 3204 - Akademisches Lehrkrankenhaus
      • Reutlingen, Germany, 72764
        • Site: 3215 - Urologische Praxis
      • Sangerhausen, Germany, 06526
        • Site: 3209 - Private Praxis
  • Latvia
      • Jelgava, Latvia, LV-3001
        • Site: 3302 - Jelgava Outpatient Clinic
      • Liepaja, Latvia, LV-3401
        • Site: 3301 - Litavniece Urologist Private Practice
      • Riga, Latvia, LV-1002
        • Site: 3303 - P. Stradins Clinical University Hospital
      • Ventspils, Latvia, LV-3601
        • Site: 3304 - Nord Kurzeme Regional Hospital
  • Lithuania
      • Kaunas, Lithuania, LT-50154
        • Site: 3404 - Motina ir vaikas clinic
      • Vilnius, Lithuania, LT-08661
        • Site: 3402 - Vilnius Univeristy Hospital "Santariskiu Klinikos" Urology Centre
      • Vilnius, Lithuania, LT-09108
        • Site: 3401 - Clinics "Privatus gydytojas"
      • Vilnius, Lithuania, LT-10207
        • Site: 3403 - Public Institution Vilnius City University Hospital
  • Poland
      • Chorzow, Poland, 41-500
        • Site: 3503 - Urovita Sp.z.o.o. NZOZ Szpital Slaskie Centrum Urologii
      • Lodz, Poland, 90-302
        • Site: 3504 - Centrum Medyczne Szpital Sw Rodziny Sp z o.o.
      • Lotum, Poland, 87-100
        • Site: 3509 - NZOZ Nasz Lekarz, Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna
      • Piaseczno, Poland, 05-500
        • Site: 3510 - Heureka Hanna Szalecka
      • Poznan, Poland, 61-397
        • Site: 3501 - Indywidualna Specjalistyczna Praktyka Lekarska
      • Siedlce, Poland, 08-110
        • Site: 3511 - Urologica Praktyka Lekarska Adam Marcheluk
      • Warszawa, Poland, 01-432
        • Site: 3508 - NZOZ Centrum Medyczna Wola
      • Warszawa, Poland, 02-005
        • Site: 3507 - Szpital Kliniczny Dzieciatka Jezus Centrum Leczenia Obrazen
      • Wroclaw, Poland, 51-124
        • Site: 3502 - Wojewodzki Szpital Specjalistyczny we Wroclawiu
      • Wroclaw, Poland, 54-144
        • Site: 3505 - EMC Instytut Medyczny SA
      • Wroclaw, Poland, 54-239
        • Site: 3506 - Specjalistyczna Praktyka Lekarska Gabinet Urologiczny
  • Spain
      • Barcelona, Spain, 8970
        • Site: 3701 - Hospital Moises Broggi de Sant Joa
      • Barcelona, Spain, CP: 08025
        • Site: 3703 - Fundació Puigvert
      • Coslada, Spain, CP:28822
        • Site: 3702 - Hospital del Henares

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Oral
Experimental: Lowest dose ASP3652 twice daily
Drug: ASP3652
Oral
Experimental: Low dose ASP3652 twice daily
Drug: ASP3652
Oral
Experimental: Medium dose ASP3652 twice daily
Drug: ASP3652
Oral
Experimental: High dose ASP3652 once daily
Drug: ASP3652
Oral
Experimental: High dose ASP3652 twice daily
Drug: ASP3652
Oral

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline in the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI), total score at 12 weeks
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in the NIH-CPSI pain domain score at week 12
Time Frame: Baseline and 12 weeks
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
Time Frame: Baseline, 4 weeks, 8 weeks and 2 weeks follow-up post 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
Time Frame: Baseline, 4 weeks, 8 weeks 2 weeks follow-up post 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
Time Frame: Baseline, 4 weeks, 8 weeks and 12 weeks treatment and weeks 2 weeks follow-up post 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
Time Frame: Baseline, 4 weeks, 8 weeks and 12 weeks treatment and weeks 2 weeks follow-up post 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
Time Frame: Baseline, 4 weeks, 8 weeks and 12 weeks treatment 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
Time Frame: 12 weeks
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
Time Frame: 12 weeks
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
Time Frame: Baseline, 4 weeks, 8 weeks 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
Time Frame: Baseline, 4 weeks, 8 weeks 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
Time Frame: Baseline and 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
Time Frame: Baseline, 4 weeks and 12 weeks treatment
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
Time Frame: Screening and 12 weeks
Screening and 12 weeks
European Quality of Life questionnaire in 5 dimensions (EQ-5D) at baseline and at 12 weeks
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks
Male sexual health questionnaire at baseline and at 12 weeks
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Astellas Pharma Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Executive Director Global Medical Science, Astellas Pharma Europe B.V.
  • Principal Investigator: Coordination Investigator, Clinic for Urology, Pediatric Urology and Andrology, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 8, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 12, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 21, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 3652-CL-0019
  • 2010-023775-25 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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