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

NCT06568718 | Completed

• 1 other identifier: LG-ADAM-23
• Study Type: interventional
• Target: 229
• Locations: 1 country
• Sites: 3

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

Conditions

Lower Urinary Tract Symptoms; Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in IPSS Score on Day 60 and 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. IPSS score ranges from 0 to 35 with higher score representing more severe symptoms.

  Day 0, Day 60, Day 130

Secondary Outcomes (9)

• Change from Baseline in IPSS Score on Day 26

  Day 0, Day 26

• Change from Baseline in Qmax

  Day 0, Day 26, Day 60, Day 130

• Change from Baseline in Prostate Volume

  Day 0, Day 26, Day 60, Day 130

• Number of Participants with 4 Points and/or 25% Decrease in IPSS Score

  Day 0, Day 26, Day 60, Day 130

• Change from Baseline in IPSS QoL Score

  Day 0, Day 26, Day 60, Day 130

Other Outcomes (1)

• Number of Participants with Treatment-Related Adverse Events

  From enrollment to the end of treatment on Day 130

Study Arms (2)

Longidaze + Tamsulosin

EXPERIMENTAL

Drug: bovhyaluronidase azoximer; Drug: tamsulosin

Tamsulosin

ACTIVE COMPARATOR

Drug: tamsulosin

Interventions

bovhyaluronidase azoximer DRUG

Longidaze 3000 IU intramuscularly once every 5 days with a course of 5 injections; Longidaze 3000 IU rectal suppositories once every 3 days with a course of 10 applications; Longidaze 3000 IU rectal suppositories once every 7 days with a course of 10 applications.

Also known as: Longidaze

Longidaze + Tamsulosin

tamsulosin DRUG

Tamsulosin 0.4mg per os every day

Longidaze + Tamsulosin; Tamsulosin

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Written Informed Consent Form for participation in the study.
• Male outpatients aged 40 years or older.
• Presence of lower urinary tract symptoms due to BPH at least 6 months prior to the screening visit.
• Symptom severity according to the International Prostate Symptom Score (IPSS) ≥ 8 at the screening visit.
• 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.
• Consent to follow the effective methods of contraception specified in the protocol throughout the study.

You may not qualify if:

• History of hypersensitivity to the study drug, background therapy drug or their components or intolerance thereof.
• Patients who require or do not wish to stop taking drugs prohibited before or during the study.
• Contraindications to the study therapy at the time of screening: acute infectious diseases; pulmonary hemorrhage and hemoptysis; fresh vitreous hemorrhage.
• 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.
• Acute prostatitis at the time of screening and/or within 4 weeks before screening.
• Symptoms of urinary tract infection at the time of screening and/or within 4 weeks before the screening visit.
• Need for planned surgical treatment of BPH and/or any other concomitant disease within 5 months from the screening visit.
• History of prostatectomy, transurethral resection and/or other surgical interventions on the prostate gland, bladder or pelvic organs.
• 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.
• History of urethral stricture.
• History of spinal injury.
• History of acute urinary retention.
• Use of any antibacterial drugs (except topical drugs) within 2 months before the screening visit.
• Use of any medications for the treatment of LUTS/BPH before the study, including herbal preparations containing extracts of Serenoa repens and Pygeum Africanum.
• History of orthostatic hypotension.

Sponsors & Collaborators

• NPO Petrovax: lead

Study Sites (3)

LLC "Krasnodar Medical and Biological Center"

Krasnodar, 350000, Russia

Location

First Saint Petersburg State Medical University named after academician I.P. Pavlov

Saint Petersburg, 197022, Russia

Location

LLC "Clinic of Modern Medicine of Dr. Bogorodskaya"

Yaroslavl, 150001, Russia

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Prostatic Hyperplasia

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Pavel I. Rasner

  University Clinic of the Scientific and Educational Institute of Clinical Medicine named after N.A. Semashko

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 23, 2024
• Study Start: March 20, 2023
• Primary Completion: February 9, 2024
• Study Completion: February 9, 2024
• Last Updated: December 31, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

RU (3)