Clinical trial NCT01391338 (phase 2, status: completed)
Conditions: chronic abacterial prostatitis, chronic pelvic pain syndrome
ICD codes: D68.61, D69.41, D81.4, E24.1, E26.01, E26.81, E34.0
Drugs: asp3652, placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility 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