E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic abacterial Prostatitis/Chronic Pelvic Pain Syndrome |
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E.1.1.1 | Medical condition in easily understood language |
Chronic pain or discomfort in the pelvic region in the absence of urinary tract infection (UTI) or other pelvic / urological cause |
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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 | 100000004872 |
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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 | 100000004872 |
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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 |
To investigate efficacy of ASP3652 in subjects with CP/CPPS, i.e., obtain proof of
concept. |
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E.2.2 | Secondary objectives of the trial |
- To assess the optimal dose of ASP3652 for treatment of subjects with CP/CPPS.
- To investigate safety and tolerability of ASP3652 in subjects with CP/CPPS.
- To investigate pharmacokinetics and pharmacodynamics of ASP3652 in subjects with CP/CPPS. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
At screening (Visit 1), the subject must:
1. have signed the informed consent
2. be male and 18 years of age or older
3. be diagnosed with CP/CPPS with moderate to severe disease activity (NIH-CPSI: total ≥15, question 4 ≥4)
4. symptoms arising from prostate or surrounding tissues/non-prostate structures
(pain on palpations and “Yes” to at least 1 item from NIH-CPSI question 1 and 2)
At randomization (Visit 2), moderate/severe disease activity has to be confirmed
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E.4 | Principal exclusion criteria |
At screening (Visit 1), the subject must not have any of the following:
1. isolated unilateral testicular, penile or scrotal pain
2. urinary tract infection in the last 3 months before screening
3. any prior prostate and/or bladder intervention 3 months before screening
4. current urologic pathology; i.e., symptomatic urethral stricture, symptomatic bladder or ureteral calculi, lower urinary tract malignancy, severe bladder outlet obstruction, overactive bladder with incontinence, significant post void residual volume, clinically significant abnormalities on trans-abdominal ultrasound of bladder and prostate and/or neurologic disorder affecting bladder function
7. currently active sexually transmittable disease
8. history of, or known inflammatory bowel disease
9. severe fibromyalgia, severe irritable bowel syndrome and/or severe chronic fatigue syndrome
10. severe constipation and/or diarrhea, active diverticulitis and/or uninvestigated gastrointestinal bleeding
substance abuse (incl. alcohol), any use of THC / positive urine test for THC |
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E.5 End points |
E.5.1 | Primary end point(s) |
The change from baseline in NIH-CPSI total score at 12 weeks of treatment (EoT). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
(Week -2), Week 0, week 4, week 8, week 12, (week 16) |
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E.5.2 | Secondary end point(s) |
The change from baseline in the NIH-CPSI pain domain (i.e., the combined score for questions 1 – 4) at week 12 (i.e., Visit 6) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
(Week -2), Week 0, week 4, week 8, week 12, (week 16) |
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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 | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
establishment of proof of concept |
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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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | Yes |
E.8.1.7.1 | Other trial design description |
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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.8.3 |
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 | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 45 |
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 | Yes |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |