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)

Astellas

Status and phase: Completed; Phase 2

Conditions: Chronic Pelvic Pain Syndrome; Chronic Abacterial Prostatitis

Treatments: Drug: Placebo; Drug: ASP3652

Study type: Interventional

Funder types: Industry

Identifiers

NCT01391338

3652-CL-0019

2010-023775-25 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 239 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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239 participants in 6 patient groups, including a placebo group

Lowest dose ASP3652 twice daily

Experimental group

Treatment:

Drug: ASP3652

Low dose ASP3652 twice daily

Experimental group

Treatment:

Drug: ASP3652

Medium dose ASP3652 twice daily

Experimental group

Treatment:

Drug: ASP3652

High dose ASP3652 once daily

Experimental group

Treatment:

Drug: ASP3652

High dose ASP3652 twice daily

Experimental group

Treatment:

Drug: ASP3652

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo