Efficacy and Safety of Longidaze in the Treatment of Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia

Not Applicable

Completed

• Conditions: Lower Urinary Tract Symptoms; Prostatic Hyperplasia
• Interventions: Drug: bovhyaluronidase azoximer; Drug: tamsulosin

• Registration Number: NCT06568718
• Lead Sponsor: NPO Petrovax

Brief Summary

The goal of this clinical trial is to learn if Longidaze works to treat lower urinary tract symptoms in adult males with benign prostatic hyperplasia. It will also learn about the safety of Longidaze. The main question it aims to answer is:

* Does addition of Longidaze to tamsulosin lower the severity of symptoms assessed by International Prostate Symptom Score?

* What medical problems do participants have under the combined treatment by Longidaze and tamsulosin?

Researchers will compare combined therapy (Longidaze + tamsulosin) with monotherapy (tamsulosin only) to see if the combination works better.

Participants will:

* Take tamsulosin (0.4mg) every day for 130 days

* In combined therapy arm -- make intramuscular injections of Longidaze every 5 days (5 injections); then apply Longidaze rectal suppositories every 3 days (10 applications); then apply Longidaze rectal suppositories every 7 days (10 applications)

* Visit the clinic on day 1, 26±1, 60±1, 130±3 for checkups and tests

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-20
• Primary Completion: 2024-02-09
• Study Completion: 2024-02-09
• Status Verified: 2024-08
• Study First Submitted: 2024-08-21
• Study First Submitted QC: 2024-08-21
• Last Update Submitted: 2024-08-21
• Study First Posted: 2024-08-23
• Last Update Posted: 2024-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 229

Inclusion Criteria

1. Signed Written Informed Consent Form for participation in the study.
2. Male outpatients aged 40 years or older.
3. Presence of lower urinary tract symptoms due to BPH at least 6 months prior to the screening visit.
4. Symptom severity according to the International Prostate Symptom Score (IPSS) ≥ 8 at the screening visit.
5. Negative urethral smear (PCR) test for chlamydia, gonorrhea, trichomoniasis, mycoplasmosis and ureaplasmosis performed no earlier than 1 month prior to study inclusion.
6. Negative blood test (ELISA) for syphilis performed no earlier than 1 month prior to study inclusion.
7. Maximum urine flow rate (Qmax) based on uroflowmetry results during screening is ≥5 ml/sec; residual urine volume during screening is up to 150 ml.
8. Consent to follow the effective methods of contraception specified in the protocol throughout the study.

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Exclusion Criteria

1. History of hypersensitivity to the study drug, background therapy drug or their components or intolerance thereof.
2. Patients who require or do not wish to stop taking drugs prohibited before or during the study.
3. Contraindications to the study therapy at the time of screening: acute infectious diseases; pulmonary hemorrhage and hemoptysis; fresh vitreous hemorrhage.
4. Hematuria, hematological diseases, oncological diseases, chronic heart failure class III-IV according to the New York Heart Association system, diabetes mellitus, chronic renal failure, hypogonadism in the history.
5. Acute prostatitis at the time of screening and/or within 4 weeks before screening.
6. Symptoms of urinary tract infection at the time of screening and/or within 4 weeks before the screening visit.
7. Need for planned surgical treatment of BPH and/or any other concomitant disease within 5 months from the screening visit.
8. History of prostatectomy, transurethral resection and/or other surgical interventions on the prostate gland, bladder or pelvic organs.
9. Neurogenic dysfunction of the bladder, congenital anomalies of the genitourinary system, sclerosis of the bladder neck, bladder diverticula, urolithiasis, bladder cancer or other bladder diseases in the medical history.
10. History of urethral stricture.
11. History of spinal injury.
12. Prostate-specific antigen (PSA) level >4 ng/ml at the screening visit or according to laboratory tests performed no more than 4 weeks before inclusion in the study.
13. History of acute urinary retention.
14. Use of any antibacterial drugs (except topical drugs) within 2 months before the screening visit.
15. Use of any medications for the treatment of LUTS/BPH before the study, including herbal preparations containing extracts of Serenoa repens and Pygeum Africanum.
16. History of orthostatic hypotension.
17. Patients with significant liver dysfunction at the screening visit: total bilirubin >2 ULN, albumin <35 g/L, prothrombin time >3 ULN.
18. Patients with significant renal dysfunction at the screening visit (blood creatinine >2 ULN), and / or patients on dialysis and / or patients with a history of kidney transplant.
19. The patient is scheduled for cataract or glaucoma surgery within 5 months after screening.
20. The presence of sexually transmitted diseases at the time of screening.
21. Patients with positive blood test results for HIV and/or hepatitis B and/or hepatitis C, performed no earlier than 1 month before the screening visit, or at the screening.
22. Decompensated diabetes mellitus (blood glucose and/or HbAc1 grade 3 or higher according to the used CTCAE 4.03 classifier);
23. Severe CNS diseases, including a history of seizures or conditions that may lead to their development; stroke or transient ischemic attack within 12 months before screening; traumatic brain injury or cases of loss of consciousness within 12 months before screening; brain tumor
24. Patients with mental disorders such as psychosis, manic-depressive disorders, chronic depression.
25. Acute or chronic gastric and/or duodenal ulcer at the time of screening.
26. History of alcoholism, drug addiction, drug abuse.
27. Participation in other interventional clinical trials of drugs less than 90 days before the screening visit.
28. Any conditions that, in the opinion of the Investigator, may interfere with the patients participation in the study, compliance with the procedures, or be contrary to his interests, as well as affect the results of the study.
29. Employees of the study center or the Sponsor company, their family members or subjects in dependent relationships.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Longidaze + Tamsulosin	bovhyaluronidase azoximer	-
Tamsulosin	tamsulosin	-
Longidaze + Tamsulosin	tamsulosin	-

Primary Outcome Measures

Name	Time	Method
Change from Baseline in IPSS on Day 60 and 130	Day 0, Day 60, Day 130	Change in symptom severity assessed by the patient using the International Prostate Symptom Score (IPSS) relative to baseline on days 60 and 130 of therapy.

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Prostate Volume	Day 0, Day 26, Day 60, Day 130	Change in prostate volume relative to baseline
Number of Participants with 4 Points and/or 25% Decrease in IPSS	Day 0, Day 26, Day 60, Day 130	Proportion of patients showing a decrease in symptom severity as assessed by the IPSS questionnaire by 4 or more points and/or by 25% from the baseline.
Change from Baseline in IPSS-S	Day 0, Day 26, Day 60, Day 130	Change in storage symptom severity assessed by the patient using the IPSS questionnaire (IPSS-S subscore) relative to baseline
Change from Baseline in NIH-CPSI	Day 0, Day 26, Day 60, Day 130	Change in symptom severity according to the NIH Chronic Prostatitis Symptom index (NIH-CPSI) questionnaire relative to the baseline
Change from Baseline in Residual Urine Volume	Day 0, Day 26, Day 60, Day 130	Change in residual urine volume based on ultrasound data relative to baseline
Change from Baseline in IPSS on Day 26	Day 0, Day 26	Change in symptom severity assessed by the patient using the International Prostate Symptom Score (IPSS) relative to baseline on day 26 of therapy.
Change from Baseline in IPSS-V	Day 0, Day 26, Day 60, Day 130	Change in voiding symptom severity assessed by the patient using the IPSS questionnaire (IPSS-V subscore) relative to baseline
Change from Baseline in Qmax	Day 0, Day 26, Day 60, Day 130	Change in maximum urine flow rate (Qmax) according to uroflowmetry relative to baseline
Change from Baseline in QoL	Day 0, Day 26, Day 60, Day 130	Change in quality of life assessed by the patient using the International Prostate Symptom Score (IPSS, QoL domain) relative to baseline

Trial Locations

Locations (3)

LLC "Krasnodar Medical and Biological Center"; 🇷🇺 Krasnodar, Russian Federation

First Saint Petersburg State Medical University named after academician I.P. Pavlov; 🇷🇺 Saint Petersburg, Russian Federation

LLC "Clinic of Modern Medicine of Dr. Bogorodskaya"; 🇷🇺 Yaroslavl, Russian Federation