Efficacy and Safety of Longidaze in the Treatment of Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia
- Conditions
- Lower Urinary Tract SymptomsProstatic Hyperplasia
- Registration Number
- NCT06568718
- Lead Sponsor
- NPO Petrovax
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 229
Inclusion Criteria:<br><br> 1. Signed Written Informed Consent Form for participation in the study.<br><br> 2. Male outpatients aged 40 years or older.<br><br> 3. Presence of lower urinary tract symptoms due to BPH at least 6 months prior to the<br> screening visit.<br><br> 4. Symptom severity according to the International Prostate Symptom Score (IPSS) = 8 at<br> the screening visit.<br><br> 5. Negative urethral smear (PCR) test for chlamydia, gonorrhea, trichomoniasis,<br> mycoplasmosis and ureaplasmosis performed no earlier than 1 month prior to study<br> inclusion.<br><br> 6. Negative blood test (ELISA) for syphilis performed no earlier than 1 month prior to<br> study inclusion.<br><br> 7. Maximum urine flow rate (Qmax) based on uroflowmetry results during screening is =5<br> ml/sec; residual urine volume during screening is up to 150 ml.<br><br> 8. Consent to follow the effective methods of contraception specified in the protocol<br> throughout the study.<br><br>Exclusion Criteria:<br><br> 1. History of hypersensitivity to the study drug, background therapy drug or their<br> components or intolerance thereof.<br><br> 2. Patients who require or do not wish to stop taking drugs prohibited before or during<br> the study.<br><br> 3. Contraindications to the study therapy at the time of screening: acute infectious<br> diseases; pulmonary hemorrhage and hemoptysis; fresh vitreous hemorrhage.<br><br> 4. Hematuria, hematological diseases, oncological diseases, chronic heart failure class<br> III-IV according to the New York Heart Association system, diabetes mellitus,<br> chronic renal failure, hypogonadism in the history.<br><br> 5. Acute prostatitis at the time of screening and/or within 4 weeks before screening.<br><br> 6. Symptoms of urinary tract infection at the time of screening and/or within 4 weeks<br> before the screening visit.<br><br> 7. Need for planned surgical treatment of BPH and/or any other concomitant disease<br> within 5 months from the screening visit.<br><br> 8. History of prostatectomy, transurethral resection and/or other surgical<br> interventions on the prostate gland, bladder or pelvic organs.<br><br> 9. Neurogenic dysfunction of the bladder, congenital anomalies of the genitourinary<br> system, sclerosis of the bladder neck, bladder diverticula, urolithiasis, bladder<br> cancer or other bladder diseases in the medical history.<br><br> 10. History of urethral stricture.<br><br> 11. History of spinal injury.<br><br> 12. Prostate-specific antigen (PSA) level >4 ng/ml at the screening visit or<br> according to laboratory tests performed no more than 4 weeks before inclusion in the<br> study.<br><br> 13. History of acute urinary retention.<br><br> 14. Use of any antibacterial drugs (except topical drugs) within 2 months before the<br> screening visit.<br><br> 15. Use of any medications for the treatment of LUTS/BPH before the study, including<br> herbal preparations containing extracts of Serenoa repens and Pygeum Africanum.<br><br> 16. History of orthostatic hypotension.<br><br> 17. Patients with significant liver dysfunction at the screening visit: total bilirubin<br> &gt;2 ULN, albumin &lt;35 g/L, prothrombin time &gt;3 ULN.<br><br> 18. Patients with significant renal dysfunction at the screening visit (blood creatinine<br> &gt;2 ULN), and / or patients on dialysis and / or patients with a history<br> of kidney transplant.<br><br> 19. The patient is scheduled for cataract or glaucoma surgery within 5 months after<br> screening.<br><br> 20. The presence of sexually transmitted diseases at the time of screening.<br><br> 21. Patients with positive blood test results for HIV and/or hepatitis B and/or<br> hepatitis C, performed no earlier than 1 month before the screening visit, or at the<br> screening.<br><br> 22. Decompensated diabetes mellitus (blood glucose and/or HbAc1 grade 3 or higher<br> according to the used CTCAE 4.03 classifier);<br><br> 23. Severe CNS diseases, including a history of seizures or conditions that may lead to<br> their development; stroke or transient ischemic attack within 12 months before<br> screening; traumatic brain injury or cases of loss of consciousness within 12 months<br> before screening; brain tumor<br><br> 24. Patients with mental disorders such as psychosis, manic-depressive disorders,<br> chronic depression.<br><br> 25. Acute or chronic gastric and/or duodenal ulcer at the time of screening.<br><br> 26. History of alcoholism, drug addiction, drug abuse.<br><br> 27. Participation in other interventional clinical trials of drugs less than 90 days<br> before the screening visit.<br><br> 28. Any conditions that, in the opinion of the Investigator, may interfere with the<br> patients participation in the study, compliance with the procedures, or be contrary<br> to his interests, as well as affect the results of the study.<br><br> 29. Employees of the study center or the Sponsor company, their family members or<br> subjects in dependent relationships.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from Baseline in IPSS on Day 60 and 130
- Secondary Outcome Measures
Name Time Method Change from Baseline in IPSS on Day 26;Change from Baseline in Qmax;Change from Baseline in Prostate Volume;Number of Participants with 4 Points and/or 25% Decrease in IPSS;Change from Baseline in QoL;Change from Baseline in IPSS-V;Change from Baseline in IPSS-S;Change from Baseline in Residual Urine Volume;Change from Baseline in NIH-CPSI