Clinical Trial of Safety and Efficacy of Afalaza in Patients With Symptoms of Benign Prostatic Hyperplasia and Risk of Progression

Phase 3

Completed

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Drug: Placebo; Drug: Afalaza

• Registration Number: NCT01716104
• Lead Sponsor: Materia Medica Holding

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-25
• Study First Submitted QC: 2012-10-25
• Study First Posted: 2012-10-29
• Study Start: 2012-11
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Results First Submitted: 2017-07-17
• Results First Submitted QC: 2017-12-18
• Results First Posted: 2018-10-09
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-01
• Last Update Posted: 2018-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 260

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo (2 tablets twice a day)	Placebo	-
Afalaza (2 tablets twice a day)	Afalaza	-

Primary Outcome Measures

Name	Time	Method
Change in Total IPSS Scores (International Prostate Symptome Score) After 1, 3, 6 and 12 Months Compared to Baseline.	Baseline, 1, 3, 6 and 12 months	The International Prostate Symptom Score (IPSS) is based on the answers to 7 questions concerning urinary symptoms plus one question concerning quality of life (QoL). Each of the seven symptoms includes the assignment of scores from 0 to 5. The total score can therefore range from 0 to 35 points (asymptomatic to very symptomatic). The patient's quality of life (QoL) was evaluated separately in this clinical study.

Secondary Outcome Measures

Name	Time	Method
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	Baseline and 3, 6 and 12 months	To assess the risk of BPH progression, the following were used: 1) moderate to severe BPH symptoms (ie, IPSS total score\> 7); 2) an increase in the volume of the prostate gland (\> 30 cm\^2); 3) increased PSA level in the blood (≥ 1.4 ng / ml); 4) a decrease in Qmax (\<12 ml / s) and 5) a large volume of residual urine (\> 200 ml).; The total value of risk factors for progression is assessed as the sum of the risk factors that the patient had at the time of inclusion in the study (presence of risk factors = 1 point, absence = 0 points). After 3, 6 and 12 months of treatment, the dynamics of risk factors for progression was assessed: an increase in the severity of the risk factor meant +1, no change = 0, a decrease in the severity of the risk factor of -1.
Change in Maximum Urinary Flow Rate After 1, 3, 6 and 12 Months Compared to Baseline	Baseline and 1, 3, 6 and 12 months
Change in Dynamics of Irritative Symptoms Evaluated by IPSS (International Prostate Symptome Score) After 1, 3, 6 and 12 Months Compared to Baseline	Baseline and 1, 3, 6, 12 months	The International Prostate Symptom Score (IPSS) is based on the answers to 7 questions concerning urinary symptoms plus one question concerning quality of life (QoL). Each of the seven symptoms includes the assignment of scores from 0 to 5. The total score can therefore range from 0 to 35 points (asymptomatic to very symptomatic). The patient's quality of life (QoL) was evaluated separately in this clinical study.; The sum of IPSS questions 2, 4, and 7 related to irritative symptoms. The total score of irritative symptoms can therefore range from 0 to 15 points (asymptomatic to very symptomatic).
Change in Average Urinary Flow Rate After 1, 3, 6 and 12 Months Compared to Baseline	Baseline and 1, 3, 6 and 12 months
Percent Change in Mean Values of Prostate Gland Volume at 3, 6 and 12 Months Compared to Baseline	Baseline and 3, 6 and 12 months	Change in the volume of the prostate gland as a percentage of the baseline according to transrectal ultrasound
Number of Episodes of Acute Urinary Retention, Surgical Intervention During the Observation Period	12 months
Change in Mean Values of Micturition Volume at 3, 6 and 12 Months Compared to Baseline	Baseline and 3, 6 and 12 months
Change in the Mean Values of Residual Urine Volume at 3, 6 and 12 Months Compared to Baseline	Baseline and 3, 6 and 12 months	according to transabdominal ultrasound
Change in Quality of Life (QoL Index of IPSS) at 3, 6 and 12 Months Compared to Baseline	Baseline and 3, 6 and 12 months	Quality of life (QoL) Due to Urinary Symptoms is an eight point of the IPSS scale referred to the patient's quality of life. The answers to this question range from "delighted" to "terrible" or 0 to 5.

Trial Locations

Locations (16)

Limited liability company "Family Policlinic No. 4"; 🇷🇺 Moscow region Koroljov, Russian Federation

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; 🇷🇺 Moscow, Russian Federation

The Federal State Budget Educational institution of High Professional Training "Peoples' Friendship University of Russia", Department of Urology and Operative Nephrology; 🇷🇺 Moscow, Russian Federation

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; 🇷🇺 Moscow, Russian Federation

The Federal State Budget institution "Polyclinic № 3" of Affairs Management Department of the President of the Russian Federation; 🇷🇺 Moscow, Russian Federation

Municipal Treatment-and-Prophylactic Health Care institution Clinical Diagnostic Centre "Zdorovie"; 🇷🇺 Rostov-on-Don, Russian Federation

The Federal State Budgetary Institution " Saint-Petersburg Research Institute Phthisiopulmonology " Ministry of Health of the Russian Federation; 🇷🇺 St. Petersburg, Russian Federation

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; 🇷🇺 St. Petersburg, Russian Federation

The Federal State Budgetary Health Care Institution "Clinical Hospital №122 n. a. L. G. Sokolov of the Federal Biomedical Agency"; 🇷🇺 St. Petersburg, Russian Federation

Limited liability company "Medical unit No. 157"; 🇷🇺 St. Petersburg, Russian Federation

Saint-Petersburg State Budget Health Care institution "Pokrovsky city hospital"; 🇷🇺 St. Petersburg, Russian Federation

The State Institution "Institute of Urology of the Ukraine National Academy of Medical Sciences"; 🇺🇦 Kyiv, Ukraine

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"; 🇷🇺 Moscow, Russian Federation

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; 🇷🇺 Moscow, Russian Federation

Limited Liability Company "Hospital OrCli"; 🇷🇺 St. Petersburg, Russian Federation

The State Budgetary Educational Institution of Higher Professional Education " Siberian state Medical University" Ministry of Health of the Russian Federation; 🇷🇺 Tomsk, Russian Federation