Clinical trial NCT01716104: Clinical Trial of Safety and Efficacy of Afalaza in Patients With Symptoms of Benign Prostatic Hyperplasia and Risk of Progression
Official title: Multicentric Double-blind Placebo-controlled Randomized Parallel-group Clinical Trial of Safety and Efficacy of Afalaza in Patients With Symptoms of Benign Prostatic Hyperplasia and Risk of Progression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Benign Prostatic Hyperplasia
Lead sponsor: Materia Medica Holding
Sponsor class: INDUSTRY
First posted: 2012-10-29
Enrollment: 260
Sex: MALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is:

* To assess safety of Afalaza drug within 12 months in patients with symptoms of benign prostatic hyperplasia (BPH) and risk of progression.
* To assess efficacy of Afalaza drug within 12 months in patients with symptoms of benign prostatic hyperplasia and risk of progression.


Eligibility criteria: Inclusion Criteria:

1. Male patients 45 to 60 y.o. inclusive with a documented diagnosis of Benign prostatic hyperplasia.
2. Lower urinary tract symptoms (LUTS) having been experienced for 3 months and longer.
3. Total IPSS score (International Prostate Symptome Score) of 8 to 15.
4. Prostate volume of more than 30 cm3.
5. Maximal urinary flow rate of 10-15 mL/sec.
6. Micturition volume of 125-350 mL.
7. Residual volume of less than 100 mL.
8. Serum prostate-specific antigen (PSA) level of less than 4 ng/mL.
9. Use of and compliance with contraceptive methods during the trial and for 30 days upon completion of participation in the trial.
10. Presence of the patient's information sheet (informed consent form) for participation in the clinical trial.

Exclusion Criteria:

1. Invasive therapies for BPH including a transurethral prostatic resection, thermotherapy, microwave therapy, transurethral needle ablation, stenting, etc.
2. Malignant oncological disease of the urogenital system as well as malignancies of any other localization during last 5 years.
3. Acute urinary retention (AUR) within 3 months before inclusion in the trial.
4. Neurogenic dysfunctions and bladder ears.
5. Urinary stone disease.
6. Urethral stricture, bladder neck sclerosis.
7. History of operative aids for pelvic organs.
8. Urogenital infections in the phase of active inflammation.
9. Systematic administration of agents exhibiting effects on bladder function and urine production.
10. Exacerbation or decompensation of chronic diseases affecting the possibility of patients to participate in the clinical trial, including severe concurrent cardiovascular conditions and disorders of the nervous system, renal and hepatic insufficiency.
11. History of administration of testosterone 5-alpha-reductase inhibitors (finasteride, dutasteride).
12. History of polyvalent allergy.
13. Allergy/intolerance to any component of drug agents used in the therapy.
14. Malabsorption syndrome, including congenital or acquired lactase or other disaccharidase deficiency.
15. Administration of drugs specified as "Prohibited concomitant therapy", within 3 months before enrollment.
16. Exacerbation or decompensation of chronic diseases affecting the possibility of patients to participate in the clinical trial.
17. Drug and alcohol consumption (over 2 alc. units daily), mental diseases. Legal incapacity or limited legal capacity.
18. Legal incapacitation or limited legal capacity.
19. Patients, who, in the investigator's opinion, will fail to observe the requirements during the trial or adhere to the studied drug administration procedure.
20. Participation in other clinical trials within 3 months before enrolment in this trial.
21. Presence of other factors, complicating the patient's participation in the trial (e.g., planned lengthy business and other trips).
22. A patient is a part of the center's research staff, taking a direct part in the trial, or an immediate family member of the investigator. Immediate family members are defined as spouses, parents, children or siblings, regardless of whether full blood or adopted.
23. The patient is employed with Scientific Production Firm Materia Medica Holding LLC, i.e. is the company's employee, part-time employee under contract, or appointed official in charge of the trial, or their immediate family.

Primary outcomes:
measure: Change in Total IPSS Scores (International Prostate Symptome Score) After 1, 3, 6 and 12 Months Compared to Baseline.
timeFrame: Baseline, 1, 3, 6 and 12 months
Secondary outcomes:
measure: Change in Dynamics of Irritative Symptoms Evaluated by IPSS (International Prostate Symptome Score) After 1, 3, 6 and 12 Months Compared to Baseline
timeFrame: Baseline and 1, 3, 6, 12 months
measure: Change in Maximum Urinary Flow Rate After 1, 3, 6 and 12 Months Compared to Baseline
timeFrame: Baseline and 1, 3, 6 and 12 months
measure: Change in Average Urinary Flow Rate After 1, 3, 6 and 12 Months Compared to Baseline
timeFrame: Baseline and 1, 3, 6 and 12 months
measure: Percent Change in Mean Values of Prostate Gland Volume at 3, 6 and 12 Months Compared to Baseline
timeFrame: Baseline and 3, 6 and 12 months
measure: Change in Mean Values of Micturition Volume at 3, 6 and 12 Months Compared to Baseline
timeFrame: Baseline and 3, 6 and 12 months
measure: Change in the Mean Values of Residual Urine Volume at 3, 6 and 12 Months Compared to Baseline
timeFrame: Baseline and 3, 6 and 12 months
measure: Change in Quality of Life (QoL Index of IPSS) at 3, 6 and 12 Months Compared to Baseline
timeFrame: Baseline and 3, 6 and 12 months
measure: Change in Total Value of Risk Factors for Progression (Total Score of IPSS, Prostate Volume, PSA Level, Maximum Urinary Flow Rate, Residual Urine Volume) Compared to Baseline
timeFrame: Baseline and 3, 6 and 12 months
measure: Number of Episodes of Acute Urinary Retention, Surgical Intervention During the Observation Period
timeFrame: 12 months
Other outcomes:
Locations:
city: Moscow region Koroljov
country: Russian Federation
facility: Limited liability company "Family Policlinic No. 4"
city: Moscow
country: Russian Federation
facility: The State Budget Health Care institution of Moscow the City "Hospital for veterans of wars No. 2 of the Administration of Health Care of Moscow City"
city: Moscow
country: Russian Federation
facility: The State Budget Health Care institution of Moscow the City "Specialized clinical (neuro-psychiatric) hospital No. 8 n.a. Z.P. Solovyov - ''Clinic of neuroses" of the Administration of Health Care of Moscow City
city: Moscow
country: Russian Federation
facility: The Federal State Budget Educational institution of High Professional Training "Peoples' Friendship University of Russia", Department of Urology and Operative Nephrology
city: Moscow
country: Russian Federation
facility: The State Budget Educational institution of High Professional Training I.M. Sechenov First Moscow State Medical University of Ministry of Health Care and Social Development of the Russian Federation, Department of Urology
city: Moscow
country: Russian Federation
facility: The State Budgetary Educational Institution of Higher Professional Education " Moscow State University of Medicine and Dentistry of A. I. Evdokimov" Ministry of Health of the Russian Federation
city: Moscow
country: Russian Federation
facility: The Federal State Budget institution "Polyclinic № 3" of Affairs Management Department of the President of the Russian Federation
city: Rostov-on-Don
country: Russian Federation
facility: Municipal Treatment-and-Prophylactic Health Care institution Clinical Diagnostic Centre "Zdorovie"
city: St. Petersburg
country: Russian Federation
facility: The Federal State Budgetary Institution " Saint-Petersburg Research Institute Phthisiopulmonology " Ministry of Health of the Russian Federation
city: St. Petersburg
country: Russian Federation
facility: The Federal State institution "All-Russian center of emergency and radiation medicine n.a. A.M. Nikiforov" of the Ministry of the Russian Federation for Affairs of civil defence, emergencies and elimination of consequences of natural disasters
city: St. Petersburg
country: Russian Federation
facility: The Federal State Budgetary Health Care Institution "Clinical Hospital №122 n. a. L. G. Sokolov of the Federal Biomedical Agency"
city: St. Petersburg
country: Russian Federation
facility: Limited liability company "Medical unit No. 157"
city: St. Petersburg
country: Russian Federation
facility: Saint-Petersburg State Budget Health Care institution "Pokrovsky city hospital"
city: St. Petersburg
country: Russian Federation
facility: Limited Liability Company "Hospital OrCli"
city: Tomsk
country: Russian Federation
facility: The State Budgetary Educational Institution of Higher Professional Education " Siberian state Medical University" Ministry of Health of the Russian Federation
city: Kyiv
country: Ukraine
facility: The State Institution "Institute of Urology of the Ukraine National Academy of Medical Sciences"
Study officials:
References:
citation: Pushkar D, Vinarov A, Spivak L, Kolontarev K, Putilovskiy M, Andrianova E, Epstein O. Efficacy and safety of Afalaza in men with symptomatic benign prostatic hyperplasia at risk of progression: a multicenter, double-blind, placebo-controlled, randomized clinical trial. Cent European J Urol. 2018;71(4):427-435. doi: 10.5173/ceju.2018.1803. Epub 2018 Dec 27.