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

October 25, 2012
April 23, 2013
November 2012
July 2014   (final data collection date for primary outcome measure)
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 ]
Change in total IPSS scores after 1, 3, 6 and 12 months compared to baseline. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01716104 on ClinicalTrials.gov Archive Site
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 ]
Dynamics of irritative symptoms evaluated by IPSS after 1, 3, 6 and 12 months compared to baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Clinical Trial of Safety and Efficiency of Afalaza in Patients With Symptoms of Benign Prostatic Hyperplasia and Risk of Progression
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

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Benign Prostatic Hyperplasia
  • Drug: Afalaza
    Safety and Efficiency
  • Drug: Placebo
    Safety and Efficiency
  • Experimental: Afalaza (2 tablets twice a day)
    Intervention: Drug: Afalaza
  • Placebo Comparator: Placebo (2 tablets twice a day)
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
September 2014
July 2014   (final data collection date for primary outcome measure)

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.
Male
45 Years to 60 Years
No
Contact: Mikhail Putilovskiy, MD +74957836804 ext 302 PutilovskiyMA@materiamedica.ru
Russian Federation
 
NCT01716104
MMH-AZ-001
No
Materia Medica Holding
Materia Medica Holding
Not Provided
Not Provided
Materia Medica Holding
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP