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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Materia Medica Holding
Sponsor:
Information provided by (Responsible Party):
Materia Medica Holding
ClinicalTrials.gov Identifier:
NCT01716104
First received: October 25, 2012
Last updated: April 23, 2013
Last verified: April 2013
  Purpose

The purpose of this study is:

  • To assess safety of Afalaza drug within 12 months in patients with symptoms of benign prostatic hyperplasia and risk of progression.
  • To assess efficiency of Afalaza drug within 12 months in patients with symptoms of benign prostatic hyperplasia and risk of progression.

Condition Intervention Phase
Benign Prostatic Hyperplasia
Drug: Afalaza
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicentric Double-blind Placebo-controlled Randomized Parallel-group Clinical Trial of Safety and Efficiency of Afalaza in Patients With Symptoms of Benign Prostatic Hyperplasia and Risk of Progression

Resource links provided by NLM:


Further study details as provided by Materia Medica Holding:

Primary Outcome Measures:
  • Change in total IPSS scores (International Prostate Symptome Score) after 1, 3, 6 and 12 months compared to baseline. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Dynamics of irritative symptoms evaluated by IPSS (International Prostate Symptome Score) after 1, 3, 6 and 12 months compared to baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: November 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Afalaza (2 tablets twice a day) Drug: Afalaza
Safety and Efficiency
Placebo Comparator: Placebo (2 tablets twice a day) Drug: Placebo
Safety and Efficiency

  Eligibility

Ages Eligible for Study:   45 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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 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 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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01716104

Contacts
Contact: Mikhail Putilovskiy, MD +74957836804 ext 302 PutilovskiyMA@materiamedica.ru

Locations
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 Recruiting
Moscow, Russian Federation, 119991
Contact: Andrey Vinarov, Prof         
Principal Investigator: Andrey Vinarov, Prof         
The Federal State Budget Educational institution of High Professional Training "Peoples' Friendship University of Russia", Department of Urology and Operative Nephrology Recruiting
Moscow, Russian Federation, 117198
Contact: Vladimir Avdoshin, Prof         
Principal Investigator: Vladimir Avdoshin, Prof         
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" Recruiting
Moscow, Russian Federation, 109472
Contact: Alexey Kornev, MD         
Principal Investigator: Alexey Kornev, MD         
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 Recruiting
Moscow, Russian Federation, 115419
Contact: Ekaterina Korshunova, MD         
Principal Investigator: Ekaterina Korshunova, MD         
The Federal State Budget institution "Polyclinic № 3" of Affairs Management Department of the President of the Russian Federation Recruiting
Moscow, Russian Federation, 129090
Contact: Vadim Surikov, MD         
Principal Investigator: Vadim Surikov, MD         
Municipal Treatment-and-Prophylactic Health Care institution Clinical Diagnostic Centre "Zdorovie" Recruiting
Rostov-on-Don, Russian Federation, 344011
Contact: Igor Aboyan, Prof         
Principal Investigator: Igor Aboyan, Prof         
Limited Liability Company "Hospital OrCli" Recruiting
St. Petersburg, Russian Federation, 199178
Contact: Vladimir Heifetz, Prof         
Principal Investigator: Vladimir Heifetz, Prof         
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 Recruiting
St. Petersburg, Russian Federation, 194044
Contact: Sergey Petrov, Prof         
Principal Investigator: Sergey Petrov, Prof         
Saint-Petersburg State Budget Health Care institution "Pokrovsky city hospital" Recruiting
St. Petersburg, Russian Federation, 199106
Contact: Andrey Gorelov, Prof         
Principal Investigator: Andrey Gorelov, Prof         
Sponsors and Collaborators
Materia Medica Holding
  More Information

No publications provided

Responsible Party: Materia Medica Holding
ClinicalTrials.gov Identifier: NCT01716104     History of Changes
Other Study ID Numbers: MMH-AZ-001
Study First Received: October 25, 2012
Last Updated: April 23, 2013
Health Authority: Russia: Ministry of Health of the Russian Federation

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male

ClinicalTrials.gov processed this record on October 02, 2014