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

NCT01716104 | Completed Phase 3 Results

• 1 other identifier: MMH-AZ-001-I
• Study Type: interventional
• Target: 260
• Locations: 2 countries
• Sites: 16

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.

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

• 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 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 Mean Values of Micturition Volume at 3, 6 and 12 Months Compared to Baseline

  Baseline and 3, 6 and 12 months

Study Arms (2)

Afalaza (2 tablets twice a day)

EXPERIMENTAL

Drug: Afalaza

Placebo (2 tablets twice a day)

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Afalaza DRUG

Safety and Efficacy

Afalaza (2 tablets twice a day)

Placebo DRUG

Safety and Efficacy

Placebo (2 tablets twice a day)

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Invasive therapies for BPH including a transurethral prostatic resection, thermotherapy, microwave therapy, transurethral needle ablation, stenting, etc.
• Malignant oncological disease of the urogenital system as well as malignancies of any other localization during last 5 years.
• Neurogenic dysfunctions and bladder ears.
• Urinary stone disease.
• Urethral stricture, bladder neck sclerosis.
• History of operative aids for pelvic organs.
• Urogenital infections in the phase of active inflammation.
• Systematic administration of agents exhibiting effects on bladder function and urine production.
• 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.
• History of administration of testosterone 5-alpha-reductase inhibitors (finasteride, dutasteride).
• History of polyvalent allergy.
• Allergy/intolerance to any component of drug agents used in the therapy.
• Malabsorption syndrome, including congenital or acquired lactase or other disaccharidase deficiency.
• Administration of drugs specified as "Prohibited concomitant therapy", within 3 months before enrollment.
• Exacerbation or decompensation of chronic diseases affecting the possibility of patients to participate in the clinical trial.

Sponsors & Collaborators

• Materia Medica Holding: lead

Study Sites (16)

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, 109472, Russia

Location

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, 115419, Russia

Location

The Federal State Budget Educational institution of High Professional Training "Peoples' Friendship University of Russia", Department of Urology and Operative Nephrology

Moscow, 117198, Russia

Location

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, 119991, Russia

Location

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, 127473, Russia

Location

The Federal State Budget institution "Polyclinic № 3" of Affairs Management Department of the President of the Russian Federation

Moscow, 129090, Russia

Location

Limited liability company "Family Policlinic No. 4"

Moscow Region Koroljov, 141060, Russia

Location

Municipal Treatment-and-Prophylactic Health Care institution Clinical Diagnostic Centre "Zdorovie"

Rostov-on-Don, 344011, Russia

Location

The Federal State Budgetary Institution " Saint-Petersburg Research Institute Phthisiopulmonology " Ministry of Health of the Russian Federation

Saint Petersburg, 191036, Russia

Location

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

Saint Petersburg, 194044, Russia

Location

The Federal State Budgetary Health Care Institution "Clinical Hospital №122 n. a. L. G. Sokolov of the Federal Biomedical Agency"

Saint Petersburg, 194291, Russia

Location

Limited liability company "Medical unit No. 157"

Saint Petersburg, 196066, Russia

Location

Saint-Petersburg State Budget Health Care institution "Pokrovsky city hospital"

Saint Petersburg, 199106, Russia

Location

Limited Liability Company "Hospital OrCli"

Saint Petersburg, 199178, Russia

Location

The State Budgetary Educational Institution of Higher Professional Education " Siberian state Medical University" Ministry of Health of the Russian Federation

Tomsk, 634050, Russia

Location

The State Institution "Institute of Urology of the Ukraine National Academy of Medical Sciences"

Kyiv, 04053, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 30680237 DERIVED

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Mikhail Putilovskiy, MD, PhD, Director of Clinical Research and Medical Information
• Organization: Materia Medica Holding

PutilovskiyMA@materiamedica.ru

+74952761571

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2012
• First Posted: October 29, 2012
• Study Start: November 1, 2012
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: November 28, 2018
• Results First Posted: October 9, 2018

Record last verified: 2018-11

Locations

RU (15); UA (1)