A Multicenter, Randomized, Placebo-controlled, Double-blind, Phase 4 Study to Evaluate the Efficacy and Safety of OM-89 in Patients With Recurrent Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
This study is planned to Evaluate the Efficacy and Safety of OM-89 in Patients with Recurrent Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 19
Maximum Age: 55
Healthy Volunteers: f
View:
• Male adults aged ≥19 to ≤55 at the time of obtaining the written consent
• Those who have t pain or discomfort in the pelvic or genital area
• NIH-CPSI (the National Institutes of Health Chronic Prostatitis Symptom Index) ≥ 15 in total score
• voluntarily signed the informed consent form to participate in this study
Locations
Other Locations
Republic of Korea
AJU Pharm Co., Ltd.
RECRUITING
Seoul
Contact Information
Primary
JUNNGMIN LEE
ajuf13001@ajupharm.co.kr
+82-02-2630-0700
Time Frame
Start Date: 2023-12-20
Estimated Completion Date: 2026-03-30
Participants
Target number of participants: 332
Treatments
Experimental: Study Drug: OM-89 (Uro-Vaxom® Capsule 60 mg (6 mg as a freeze-dried bacterial lysate))
\- OM-89 (Uro-Vaxom® Capsule 60 mg (6 mg as a freeze-dried bacterial lysate)) Oral administration of the investigational product (OM-89 \[Uro-Vaxom® Capsule\] or the placebo) once a day.
Placebo_comparator: Comparator:
\- Placebo of Uro-Vaxom® Capsule Oral administration of the investigational product (OM-89 \[Uro-Vaxom® Capsule\] or the placebo) once a day.
Related Therapeutic Areas
Sponsors
Leads: AJU Pharm Co., Ltd.
Collaborators: OM Pharma SA