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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01391338
First received: July 8, 2011
Last updated: March 19, 2013
Last verified: March 2013
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 B.V.
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 August 20, 2014