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

Purpose

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.

Condition	Intervention	Phase
Chronic Abacterial Prostatitis Chronic Pelvic Pain Syndrome	Drug: ASP3652 Drug: Placebo	Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Pelvic Pain

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in the NIH-CPSI pain domain score at week 12 [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
The proportion of Clinical Responders [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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
Genitourinary pain index (GUPI) total score, sub domain and responders, at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Responder defined as 7 points or more decrease from baseline
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Based on daily urinary symptom diary for 3 consecutive days in the weeks prior to the visits at baseline, 4 and 12 weeks treatment
International Prostate Symptom Score at screening and at 12 weeks [ Time Frame: Screening and 12 weeks ] [ Designated as safety issue: No ]
European Quality of Life questionnaire in 5 dimensions (EQ-5D) at baseline and at 12 weeks [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Male sexual health questionnaire at baseline and at 12 weeks [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	239
Study Start Date:	June 2011
Study Completion Date:	February 2013
Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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
Placebo Comparator: Placebo	Drug: Placebo Oral

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01391338

Show 49 Study Locations

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:	Executive Director Global Medical Science	Astellas Pharma Europe BV
Principal Investigator:	Coordination Investigator	Clinic for Urology, Pediatric Urology and Andrology, Germany

More Information

No publications provided

Responsible Party:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT01391338 History of Changes
Other Study ID Numbers:	3652-CL-0019, 2010-023775-25
Study First Received:	July 8, 2011
Last Updated:	March 19, 2013
Health Authority:	Czech Republic: State Institute for Drug Control Germany: Federal Institute for Drugs and Medical Devices Italy: The Italian Medicines Agency Latvia: State Agency of Medicines Lithuania: State Medicine Control Agency - Ministry of Health Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Spain: Spanish Agency of Medicines

Keywords provided by Astellas Pharma Inc:

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

Additional relevant MeSH terms:

Pelvic Pain
Prostatitis
Somatoform Disorders
Pain

Signs and Symptoms
Prostatic Diseases
Genital Diseases, Male
Mental Disorders

ClinicalTrials.gov processed this record on June 18, 2013

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)