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Exploratory placebo-controlled double-blind study of NS-580 in patients with chronic prostatitis/chronic pelvic pain syndrome (early phase II)

Exploratory placebo-controlled double-blind study of NS-580 in patients with chronic prostatitis/chronic pelvic pain syndrome (early phase II)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2031230134
Enrollment
150
Registered
2023-06-13
Start date
2023-06-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic prostatitis/Chronic pelvic pain syndrome(CP/CPPS)

Interventions

Participant will receive one of two oral doses of NS-580 and/or placebo over a treatment period.

Sponsors

Higashioka Masaya
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1) Patients with persistent or recurrent pelvic pain or discomfort for a total of at least 3 months out of 6 months up to the date of primary registration 2) Patients with pain or discomfort in the prostate or perineum/pubic region on palpation 3) Patients who answered 'yes' to at least one of the six items in questions 1 and 2 of the National Institutes of Health Chronic Prostate Symptom Score (NIH-CPSI)

Exclusion criteria

Exclusion criteria: 1) Patients diagnosed with urinary tract infection or bacterial prostatitis by the Pre and Post Massage Test (PPMT) method 2) Patients with complications with pelvic pain not attributable to CP/CPPS (e.g. inflammatory bowel disease, irritable bowel syndrome) 3) Patients with complications of diseases around the anus, including inguinal hernia and haemorrhoids, which the principal investigator (sub-investigator) considers to have a potential risk that may interrupt the assessment of efficacy

Design outcomes

Primary

MeasureTime frame
Change in total NIH-CPSI score from the baseline to each mesurement time point

Contacts

Public ContactOperations Clinical

Nippon Shinyaku Co., Ltd.

zz_mail_clinical-trials@po.nippon-shinyaku.co.jp+81-120-40-8930

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026