E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic prostatitis and chronic pelvic pain syndrome |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Male diseases of the urinary and reproductive systems [C12] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10064189 |
E.1.2 | Term | Chronic pelvic pain syndrome |
E.1.2 | System Organ Class | 10038604 - Reproductive system and breast disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009109 |
E.1.2 | Term | Chronic prostatitis |
E.1.2 | System Organ Class | 10038604 - Reproductive system and breast disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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.
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E.2.2 | Secondary objectives of the trial |
· 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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Males aged 30 to <= 60 years.
- CP/CPPS (type II or III): pain or discomfort in the pelvic region for at least 3 months in the previous 6 months. Corresponding symptoms can be perineal, lower abdominal, testicular and / or penile, rectal and lower back, suprapubic, and may be associated with ejaculatory discomfort or voiding (associated voiding symptoms are irritative or obstructive in nature, similar to symptoms associated with benign prostatic hyperplasia).
- NIH-CPSI ≥ 15.
- Written informed consent obtained from the patients.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 24 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 32 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of the last subject |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 22 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 5 |
E.8.9.2 | In all countries concerned by the trial days | 22 |