Chronic prostatitis and chronic pelvic pain syndrome MedDRA version: 14.1 Level: LLT Classification code 10064189 Term: Chronic pelvic pain syndrome System Organ Class: 10038604 - Reproductive system and breast disorders MedDRA version: 14.1 Level: LLT Classification code 10009109 Term: Chronic prostatitis System Organ Class: 10038604 - Reproductive system and breast disorders
Conditions
Interventions
Trade Name: Uro-Vaxom
Pharmaceutical Form: Capsule
Current Sponsor code: OM 89
Other descriptive name: ESCHERICHIA COLI, LYOPHILIZED
Concentration unit: mg milligram(s)
Concentration type: equal
Conce
Sponsors
OM Pharma SA
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Males aged 30 to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Any prostate, bladder, or urethral cancer, seizure disorder. - Concurrent inflammatory bowel disease, disorder affecting the bladder; liver disease - Prior 12 months diagnosed with or treated for symptomatic genital herpes. - Prior 3 months urinary tract infection, with a urine culture value of > 100,000 CFU/mL; clinical evidence of urethritis, sexually transmitted diseases, symptoms of acute or chronic epididymitis. - Any pelvic radiation, systemic chemotherapy; intravesical chemotherapy; intravesical BCG, TURP, TUIP, TUIBN, TUMT, TUNA, any other prostate surgery or treatment such as cryotherapy or thermal therapy; prior treatment for orchialgia without pelvic symptoms to treatment. - Prior 3 months prostate biopsy. - Patients who are unable to comply with the requirements of the protocol (e.g. psychiatric problems; knowledge of language, etc.). - Patients with a known allergy or previous intolerance or known hypersensitivity to the trial drug. - Participation in another clinical trial and/or treatment with an experimental drug within 3 months before study start and during the present trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this double-blind study is to evaluate the efficacy and the safety of Uro-Vaxom® compared to placebo on the evolution of the disease in adults suffering from chronic prostatitis and CPPS 2 & 3. ;Secondary Objective: · A reduction of NIH-CPSI score > 6 at the end of the first treatment period (Visit 4) compared to baseline. · Change in NIH-CPSI score at the end of follow-up period compared to baseline. · A difference of at least 3 points from baseline in NIH-CPSI. · Subscales of the NIH-CPSI: o Pain: total of items 1a, 1b, 1c, 1d, 2a, 2b, 3 & 4. o Urinary symptoms: total of items 5 & 6. o QoL Impact: total of items 7, 8 & 9. · Treatments required during study period (antibiotics, quercetine, analgesics, relaxants, sedatives, a-blockers, etc). · Global assessments of efficacy by patients and investigators. · Results of both stratified by type of prostatitis (II, IIIA and IIIb) and nonstratified analyses are reported · Results of subgroup analysis by alpha-blocker intake (prior 4 weeks before enrolment) for the NIH-CPSI;Primary end point(s): The primary efficacy variable is based on the evolution of NIH-CPSI assuming a population similar to the population studied by Nickel et al, a ‘Responder’ at end of treatment is a patient with a reduction of NIH-CPSI score > or = 6.;Timepoint(s) of evaluation of this end point: End of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary efficacy variables are: • A reduction of NIH-CPSI score > or = 6 at the end of the first treatment period (Visit 4) compared to baseline. • Change in NIH-CPSI score at the end of follow-up period compared to baseline. • A difference of at least 3 points from baseline in NIH-CPSI. • The subscales of the NIH-CPSI will also be evaluated as secondary endpoints to analyse changes in individual domains: o Pain: total of items 1a, 1b, 1c, 1d, 2a, 2b, 3 & 4. o Urinary symptoms: total of items 5 & 6. o QoL Impact: total of items 7, 8 & 9. • Treatments required during study period (antibiotics, quercetine, analgesics, relaxants, sedatives, a-blockers, etc). • Global assessments of efficacy by patients and investigators. • Results of both stratified by type of prostatitis (II, IIIA and IIIb) and nonstratified analyses are reported. ;Timepoint(s) of evaluation of this end point: Please refer to E.5.2 | — |
Countries
Austria, Germany, Portugal
Outcome results
None listed