E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Benign prostate hyperplasia |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10014840 |
E.1.2 | Term | Enlarged prostate (benign) |
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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 primary endpoint of this study is the response rate according to the IPS score based on the comparison of the results of the baseline visit (V2) and after 12 months (V7) |
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E.2.2 | Secondary objectives of the trial |
·Change in IPSS from baseline at randomization visit (V2) to the end of treatment after 12 months at visit 7 ·Development of IPSS over time ·Development of irritative and obstructive symptoms over time ·Changes of urodynamical examinations by measuring maximum urinary flow (Qmax) ·Changes of urodynamical examinations by measuring residual urinary volume ·Frequency of AUR ·Change in QoL ·Change in prostatic volume ·Adverse events ·Premature study withdrawals
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
In a sub-study to be conducted in five investigational sites in Slovak Republic involving a reduced number of patients histological changes in the prostate will be evaluated, as far as specimen will be available. Details to the evaluation and the parameters can be found in a separate sub-study protocol. |
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E.3 | Principal inclusion criteria |
1. Male patients, 50 years or older 2. IPSS ≥ 13 3. Stable IPS score over the 4 week run-in period allowing a deviation of ± 2 points to be assessed at the randomization visit (V2) 4. PSA < 10,0 ng/ml 5. Maximum urinary flow (Qmax) ≤ 15 ml/sec 6. Residual urinary volume ≤ 100 ml 7. Voided volume > 150 ml 8. Prostate volume > 30 ml 9. Diagnosis of benign prostate hyperplasia upon palpation 10. QoL ≥ 3 (assessed by QoL question of the IPSS)
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E.4 | Principal exclusion criteria |
1. IPSS ≥ 20 2. Prostate cancer 3. Any other malignancy 4. Bladder neck or prostate surgery 5. Lower urinary tract infection ( > 104 CFU/ml urine) 6. Patient with an indication for a surgery (anuria, macrohaematuria, recidivating urinary tract infections, concrement of the bladder, postrenal acute renal insufficiency) 7. Cystolithiasis 8. Irradiation of the pelvis 9. Any disorders causing micturition disturbances including prostatitis, neurogenic voiding disturbances 10. Urethral stricture 11. Previous veneric infections 12. Systemic immunological disorder 13. Diabetes mellitus 14. Diabetic polyneuropathy 15. Neurologic disorders 16. Abnormal liver and kidney function (twice the upper normal limit of serum aminotransferases and / or bilirubin, creatinine > 160 µmol/l), assessed at screening visit (V1) 17. Treatment for BPH with an α-blocker or any phytotherapeutic agent within 6 weeks before randomization 18. Treatment for BPH with a 5-α-reductase inhibitor within 6 months before randomization 19. Diuretics or drugs with antiandrogenic or α-receptor properties administered during the preceding 6 months for nonurological diseases (hypertension, cerebrovascular insufficiency) before randomization 20. Anticholinergic agents, anti-inflammatory drugs (NSAIDs, steroids) or any medication affecting detrusor, external or internal sphincter muscle 21. Other medication to treat bladder dysfunction: tolterodine HCL, propiverine HCL, solifenacine succinate, trospium chloride within 6 weeks before randomization. 22. Known hypersensitivity to study drug 23. Drug abuse 24. Participation in another clinical trial in the previous 3 months
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint of this study is the response rate according to the IPS score based on the comparison of the results of the baseline visit (V2) and after 12 months (V7). |
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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 | No |
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 | 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) | Yes |
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 | 9 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 60 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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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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 | 8 |
E.8.9.1 | In the Member State concerned days | |
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 | 8 |