Chronic Prostatitis With Chronic Pelvic Pain SyndromePhase 4NCT06345014
The Efficacy and Safety of OM-89 in Patients With Recurrent Chronic Prostatitis/Chronic Pelvic Pain Syndrome
A Phase 4 study testing OM-89 [Uro-Vaxom® Capsule] in people with Chronic Prostatitis With Chronic Pelvic Pain Syndrome and Chronic Prostatitis, run by AJU Pharm Co., Ltd. at 1 site in South Korea.
Trial 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) Read more about this study
- Who is it for?
- Ages 19 to 55 years, men only
- Conditions the study is for
- Chronic Prostatitis With Chronic Pelvic Pain Syndrome, Chronic Prostatitis, Chronic Pelvic Pain Syndrome
- What is being tested?
- OM-89 [Uro-Vaxom® Capsule]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 332 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Dec 2023to 30 Mar 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Prostate specific antigen (PSA) ≥ 4.0 ng/ml at Visit 1 (screening)
- Received a prostate biopsy, surgery, or treatment within 12 weeks before Visit 1 (screening)
- Past or current medical history as Herpes infection treatment within 1 year before the Screening,Treatment for genital infections or sexually transmitted diseases and History of urogenital tumors.
- Those who have a medication history of the drugs(Drugs or health functional food, Health functional foods that affect prostate function etc)or have a plan to receive them during the study at Visit 1
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
AJU Pharm Co., Ltd.
Seoul
JUNGMIN LEE, +82-02-2630-0700, ajuf13001@ajupharm.co.kr
About this study
Official title: 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)
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)
Read the detailed description
This clinical study is designed as a multicenter, randomized, placebo-controlled, double-blind, phase 4 study to evaluate the efficacy and safety of the combination therapy of Uro-Vaxom® Capsule and alfuzosin in patients with recurrent chronic prostatitis.
Once a subject voluntarily gives written consent to participate in this study, a screening test will be conducted to evaluate their eligibility. Subjects determined to be eligible to participate in the study on Visit 2 (baseline) will be enrolled, randomized 1:1 either to the test group (OM-89 [Uro-Vaxom® Capsule]) or the control group (placebo of OM-89) and administered the investigational product for 26 weeks.
In parallel, an alpha blocker (alfuzosin 10 mg) will be administered for the first 13 weeks as a background treatment, followed by the placebo of alfuzosin until Week 26.
The efficacy and safety will be checked until Week 52 from the start of the treatment for all subjects.
- Conditions
- Chronic Prostatitis With Chronic Pelvic Pain Syndrome, Chronic Prostatitis, Chronic Pelvic Pain Syndrome
- Being tested
- OM-89 [Uro-Vaxom® Capsule], OM-89 Placebo [Uro-Vaxom® Capsule Placebo]
- Keywords
- CP/CPPS, Chronic Prostatitis, Chronic Pelvic Pain Syndrome
- Medical subject headings
- Prostatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OM-89 [Uro-Vaxom® Capsule]Drug
Also called Test Group(OM-89 group)
Oral administration of the investigational product (OM-89 [Uro-Vaxom® Capsule] or the placebo) once a day
OM-89 Placebo [Uro-Vaxom® Capsule Placebo]Drug
Also called Placebo Group(OM-89 Placebo group)
Oral administration of the investigational product(Placebo of Uro-Vaxom® Capsule)
| Study group | Role | What they receive |
|---|---|---|
| Study Drug: OM-89 (Uro-Vaxom® Capsule 60 mg (6 mg as a freeze-dried bacterial lysate)) | Experimental | - 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. Receives: Drug: OM-89 [Uro-Vaxom® Capsule] |
| Comparator: | Placebo comparator | - Placebo of Uro-Vaxom® Capsule Oral administration of the investigational product (OM-89 [Uro-Vaxom® Capsule] or the placebo) once a day. Receives: Drug: OM-89 Placebo [Uro-Vaxom® Capsule Placebo] |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIH-CPSI total score
National Institute of Health Chronic Prostatitis Symptom Index (Minimum Score = 0 to Maximum Score=43, Higher score means worse outcome)
Measured: WEEK 4, 13, 26, 39, 52
Secondary outcomes (2)
NIH-CPSI domain score
pain, urinary symptoms, and effect on quality of life (Higher score means worse outcome)
Measured: WEEK 4, 13, 26, 39, 52
Subject and Investigator's Global Assessment
Subject and Investigator's Global Assessment (Higher score means worse outcome, Very dissatisfied=1 to very satisfied=5)
Measured: WEEK 4, 13, 26, 39, 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start20 Dec 2023
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Prostatitis With Chronic Pelvic Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Once a subject voluntarily gives written consent to participate in this study, a screening test will be conducted to evaluate their eligibility. Subjects determined to be eligible to participate in the study on Visit 2 (baseline) will be enrolled, randomized 1:1 either to the test group (OM-89 \[Uro-Vaxom® Capsule\]) or the control group (placebo of OM-89) and administered the investigational product for 26 weeks. In parallel, an alpha blocker (alfuzosin 10 mg) will be administered for the first 13 weeks as a background treatment, followed by the placebo of alfuzosin until Week 26. The efficacy and safety will be checked until Week 52 from the start of the treatment for all subjects.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 332 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AJU Pharm Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- OM Pharma SA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06345014
- Sponsor's protocol ID
- 23CP40803
- Status last verified
- Apr 2024
- First submitted
- 24 Mar 2024
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06345014
- Acronym / sponsor ID
- 23CP40803
- Conditions
- Chronic Prostatitis With Chronic Pelvic Pain Syndrome, Chronic Prostatitis, Chronic Pelvic Pain Syndrome
- Keywords
- CP/CPPS, Chronic Prostatitis, Chronic Pelvic Pain Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 332 participants (estimated)
- Lead sponsor
- AJU Pharm Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- OM Pharma SA
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
This clinical study is designed as a multicenter, randomized, placebo-controlled, double-blind, phase 4 study to evaluate the efficacy and safety of the combination therapy of Uro-Vaxom® Capsule and alfuzosin in patients with recurrent chronic prostatitis.
Once a subject voluntarily gives written consent to participate in this study, a screening test will be conducted to evaluate their eligibility. Subjects determined to be eligible to participate in the study on Visit 2 (baseline) will be enrolled, randomized 1:1 either to the test group (OM-89 [Uro-Vaxom® Capsule]) or the control group (placebo of OM-89) and administered the investigational product for 26 weeks.
In parallel, an alpha blocker (alfuzosin 10 mg) will be administered for the first 13 weeks as a background treatment, followed by the placebo of alfuzosin until Week 26.
The efficacy and safety will be checked until Week 52 from the start of the treatment for all subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Once a subject voluntarily gives written consent to participate in this study, a screening test will be conducted to evaluate their eligibility. Subjects determined to be eligible to participate in the study on Visit 2 (baseline) will be enrolled, randomized 1:1 either to the test group (OM-89 [Uro-Vaxom® Capsule]) or the control group (placebo of OM-89) and administered the investigational product for 26 weeks. In parallel, an alpha blocker (alfuzosin 10 mg) will be administered for the first 13 weeks as a background treatment, followed by the placebo of alfuzosin until Week 26. The efficacy and safety will be checked until Week 52 from the start of the treatment for all subjects.
| Arm | Type | Receives |
|---|---|---|
| Study Drug: OM-89 (Uro-Vaxom® Capsule 60 mg (6 mg as a freeze-dried bacterial lysate)) | Experimental | Drug: OM-89 [Uro-Vaxom® Capsule]- 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. |
| Comparator: | Placebo comparator | Drug: OM-89 Placebo [Uro-Vaxom® Capsule Placebo]- Placebo of Uro-Vaxom® Capsule Oral administration of the investigational product (OM-89 [Uro-Vaxom® Capsule] or the placebo) once a day. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Prostate specific antigen (PSA) ≥ 4.0 ng/ml at Visit 1 (screening)
- Received a prostate biopsy, surgery, or treatment within 12 weeks before Visit 1 (screening)
- Past or current medical history as Herpes infection treatment within 1 year before the Screening,Treatment for genital infections or sexually transmitted diseases and History of urogenital tumors.
- Those who have a medication history of the drugs(Drugs or health functional food, Health functional foods that affect prostate function etc)or have a plan to receive them during the study at Visit 1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OM-89 [Uro-Vaxom® Capsule]Also: Test Group(OM-89 group)Oral administration of the investigational product (OM-89 [Uro-Vaxom® Capsule] or the placebo) once a day | Drug | Study Drug: OM-89 (Uro-Vaxom® Capsule 60 mg (6 mg as a freeze-dried bacterial lysate)) |
| OM-89 Placebo [Uro-Vaxom® Capsule Placebo]Also: Placebo Group(OM-89 Placebo group)Oral administration of the investigational product(Placebo of Uro-Vaxom® Capsule) | Drug | Comparator: |
Primary outcome
NIH-CPSI total score
Time frame: WEEK 4, 13, 26, 39, 52
National Institute of Health Chronic Prostatitis Symptom Index (Minimum Score = 0 to Maximum Score=43, Higher score means worse outcome)
2 secondary outcomes
NIH-CPSI domain score
Time frame: WEEK 4, 13, 26, 39, 52
Subject and Investigator's Global Assessment
Time frame: WEEK 4, 13, 26, 39, 52
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing OM-89 [Uro-Vaxom® Capsule] in people with Chronic Prostatitis With Chronic Pelvic Pain Syndrome and Chronic Prostatitis, run by AJU Pharm Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JUNNGMIN LEE (+82-02-2630-0700, ajuf13001@ajupharm.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NIH-CPSI total score (time frame: WEEK 4, 13, 26, 39, 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.