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

Benign Prostatic Hyperplasia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01716104
• Other study ID #: MMH-AZ-001-I
• Status: Completed
• Phase: Phase 3
• Start date: November 2012
• Est. completion date: November 2016

Study information

• Verified date: November 2018
• Source: Materia Medica Holding
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• Afalaza
Safety and Efficacy
• Placebo
Safety and Efficacy

Locations

Country	Name	City	State
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 Federal State Budget institution "Polyclinic ? 3" of Affairs Management Department of the President of the Russian Federation	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 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 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 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 "Family Policlinic No. 4"	Moscow region Koroljov
Russian Federation	Municipal Treatment-and-Prophylactic Health Care institution Clinical Diagnostic Centre "Zdorovie"	Rostov-on-Don
Russian Federation	Limited Liability Company "Hospital OrCli"	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 Federal State Budgetary Health Care Institution "Clinical Hospital ?122 n. a. L. G. Sokolov of the Federal Biomedical Agency"	St. Petersburg
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 State Budgetary Educational Institution of Higher Professional Education " Siberian state Medical University" Ministry of Health of the Russian Federation	Tomsk
Ukraine	The State Institution "Institute of Urology of the Ukraine National Academy of Medical Sciences"	Kyiv

Sponsors (1)

Lead Sponsor	Collaborator
Materia Medica Holding

Countries where clinical trial is conducted

Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Total IPSS Scores (International Prostate Symptome Score) After 1, 3, 6 and 12 Months Compared to Baseline.	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.	Baseline, 1, 3, 6 and 12 months
Secondary	Change in Dynamics of Irritative Symptoms Evaluated by IPSS (International Prostate Symptome Score) After 1, 3, 6 and 12 Months Compared to Baseline	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).	Baseline and 1, 3, 6, 12 months
Secondary	Change in Maximum Urinary Flow Rate After 1, 3, 6 and 12 Months Compared to Baseline		Baseline and 1, 3, 6 and 12 months
Secondary	Change in Average Urinary Flow Rate After 1, 3, 6 and 12 Months Compared to Baseline		Baseline and 1, 3, 6 and 12 months
Secondary	Percent Change in Mean Values of Prostate Gland Volume at 3, 6 and 12 Months Compared to Baseline	Change in the volume of the prostate gland as a percentage of the baseline according to transrectal ultrasound	Baseline and 3, 6 and 12 months
Secondary	Change in Mean Values of Micturition Volume at 3, 6 and 12 Months Compared to Baseline		Baseline and 3, 6 and 12 months
Secondary	Change in the Mean Values of Residual Urine Volume at 3, 6 and 12 Months Compared to Baseline	according to transabdominal ultrasound	Baseline and 3, 6 and 12 months
Secondary	Change in Quality of Life (QoL Index of IPSS) at 3, 6 and 12 Months Compared to Baseline	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.	Baseline and 3, 6 and 12 months
Secondary	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	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.	Baseline and 3, 6 and 12 months
Secondary	Number of Episodes of Acute Urinary Retention, Surgical Intervention During the Observation Period		12 months