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Benign Prostatic HyperplasiaPhase 3NCT01716104

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

A Phase 3 study testing Afalaza in people with Benign Prostatic Hyperplasia, run by Materia Medica Holding at 16 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 45 to 60 years, men only
Conditions the study is for
Benign Prostatic Hyperplasia
What is being tested?
Afalaza
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
260 participants
Where
16 sitesin 2 countries
Study dates
Nov 2012to Nov 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 60 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
  • Acute urinary retention (AUR) within 3 months before inclusion in the trial.
  • Neurogenic dysfunctions and bladder ears.
  • Urinary stone disease.
  • Urethral stricture, bladder neck sclerosis.
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  • 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.
  • Drug and alcohol consumption (over 2 alc. units daily), mental diseases. Legal incapacity or limited legal capacity.
  • Legal incapacitation or limited legal capacity.
  • Patients, who, in the investigator's opinion, will fail to observe the requirements during the trial or adhere to the studied drug administration procedure.
  • Participation in other clinical trials within 3 months before enrolment in this trial.
  • Presence of other factors, complicating the patient's participation in the trial (e.g., planned lengthy business and other trips).
  • 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.
  • 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.

Trial locations and contacts

16 sites in 2 countries.

16 sites in 2 countries

Russia15 sites

  • 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

  • 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

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

    Moscow, 117198

  • 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

  • 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

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

    Moscow, 129090

  • Limited liability company "Family Policlinic No. 4"

    Moscow Region Koroljov, 141060

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

    Rostov-on-Don, 344011

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

    Saint Petersburg, 191036

  • 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

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

    Saint Petersburg, 194291

  • Limited liability company "Medical unit No. 157"

    Saint Petersburg, 196066

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

    Saint Petersburg, 199106

  • Limited Liability Company "Hospital OrCli"

    Saint Petersburg, 199178

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

    Tomsk, 634050

Other trials in Russia

Ukraine1 site

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

    Kyiv, 04053

Other trials in Ukraine

About this study

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

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.
Being tested
Afalaza, Placebo
Medical subject headings
Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AfalazaDrug

    Safety and Efficacy

  • PlaceboDrug

    Safety and Efficacy

Study groups in NCT01716104
Study groupRoleWhat they receive
Afalaza (2 tablets twice a day)ExperimentalNot described
Receives: Drug: Afalaza
Placebo (2 tablets twice a day)Placebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, 1, 3, 6 and 12 months

Secondary outcomes (9)

  1. 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).

    Measured: Baseline and 1, 3, 6, 12 months

  2. Change in Maximum Urinary Flow Rate After 1, 3, 6 and 12 Months Compared to Baseline

    Measured: Baseline and 1, 3, 6 and 12 months

  3. Change in Average Urinary Flow Rate After 1, 3, 6 and 12 Months Compared to Baseline

    Measured: Baseline and 1, 3, 6 and 12 months

  4. 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

    Measured: Baseline and 3, 6 and 12 months

  5. Change in Mean Values of Micturition Volume at 3, 6 and 12 Months Compared to Baseline

    Measured: Baseline and 3, 6 and 12 months

  6. Change in the Mean Values of Residual Urine Volume at 3, 6 and 12 Months Compared to Baseline

    according to transabdominal ultrasound

    Measured: Baseline and 3, 6 and 12 months

  7. 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.

    Measured: Baseline and 3, 6 and 12 months

  8. 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.

    Measured: Baseline and 3, 6 and 12 months

  9. Number of Episodes of Acute Urinary Retention, Surgical Intervention During the Observation Period

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2012 (estimated)
  2. Study startNov 2012
  3. Primary completionNov 2016
  4. Study completionNov 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
260 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01716104
Sponsor's protocol ID
MMH-AZ-001-I
Status last verified
Nov 2018
First submitted
25 Oct 2012
Last updated
28 Nov 2018
Data monitoring committee
No

Publications

  • 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.

    PubMed 30680237

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Afalaza in people with Benign Prostatic Hyperplasia, run by Materia Medica Holding at 16 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Russia, Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Total IPSS Scores (International Prostate Symptome Score) After 1, 3, 6 and 12 Months Compared to Baseline. (time frame: Baseline, 1, 3, 6 and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01716104, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2018.

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