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ACTIVE NOT RECRUITING

NCT06284265

PHASE3

Clinical Trial of the Efficacy and Safety of Raphamin in Prevention of Recurrences of Chronic Bacterial Cystitis

Sponsor: Materia Medica Holding

View on ClinicalTrials.gov

Summary

Clinical Trial of the Efficacy and Safety of Raphamin in Prevention of Recurrences of Chronic Bacterial Cystitis

Official title: Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel-group Clinical Trial of the Efficacy and Safety of Raphamin in Prevention of the Recurrences of Chronic Bacterial Cystitis

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

415

Start Date

2023-10-16

Completion Date

2026-12-31

Last Updated

2026-02-13

Healthy Volunteers

Conditions

Cystitis Chronic Cystitis Bacterial Recurrence of Chronic Bacterial Cystitis

Interventions

DRUG

Raphamin

Tablet for oral use.

DRUG

Placebo

Tablet for oral use.

Inclusion Criteria: 1. Female patients aged 18 years and older. 2. Patients with a confirmed diagnosis of chronic bacterial cystitis. 3. Patients with exacerbation of chronic cystitis based on typical symptoms of exacerbation of the disease with a severity of 7 points or more in accordance wuth ACSS. 4. The first 48 hours from the onset of exacerbation) of chronic bacterial cystitis. 5. Patients who agreed to use an acceptable method of contraception during the study (for women of reproductive potential). 6. Availability of a signed patient information sheet and informed consent form for participation in the clinical trial. Exclusion Criteria: 1. Presence of urolithiasis, urinary tract obstruction, urothelial cancer, pelvic organ prolapse, neurogenic bladder disorders at the time of examination. 2. Presence of malignant neoplasms of the urinary tract, ureter stone, more than 50 ml of residual urine in the bladder, confirmed by ultrasound examination. 3. Suspicion of bladder tuberculosis. 4. Presence of indications for hospitalization due to a serious condition, macrohematuria, complicated cystitis. 5. Decompensation of diabetes mellitus, immunodeficiency of any etiology, malignant cancer of any localization, severe circulatory insufficiency (cardiovascular disease with functional class IV according to the classification of the New York Heart Association, 1964). 6. Unstable angina pectoris or myocardial infarction within the previous 6 months. 7. Chronic kidney disease (classes С3-5 А3). 8. Hepatic impairment (Child-Pugh class C). 9. Patients who require medicinal products prohibited for use in this study. 10. Exacerbation or decompensation of chronic conditions affecting the patient's ability to participate in the clinical trial. 11. Malabsorption syndrome, including congenital or acquired lactase deficiency or other disaccharidase insufficiency, galactosemia. 12. Hypersensitivity to any component of the medicinal products used in the treatment. 13. Pregnancy, breastfeeding; childbirth less than 3 months prior to study enrollment, unwillingness to comply with contraceptive methods during the study. 14. The medications listed in the Prohibited Concomitant Medication section were administered within 4 weeks prior to enrollment. 15. Patients who, from the investigator's point of view, will not comply with the observation requirements of the study or comply with the administration of the study drug. 16. History of mental diseases, alcoholism, or drug abuse that, in the investigator's opinion, may interfere with the successful completion of trial procedures. 17. Participation in other clinical trials within 3 months prior to enrollment. 18. The patient belongs to the investigational site personnel directly involved in the study, closest relatives of the investigator. The closest relatives are defined as spouse, parents, children or siblings, regardless of whether they are natural or adopted. 19. The patient works for the company OOO "NPF "MATERIA MEDICA HOLDING", being an employee of the company, a temporary contract worker or an appointed official responsible for performing the trial, or their close relative.

Locations (49)

Scientific Center for Family Health and Human Reproduction Problems/Reproductive Health Department

Irkutsk, Russia

Kazan State Medical University/Professor's clinic

Kazan', Russia

LLC "Fenareta" Women's and Men's Health Clinic"

Kemerovo, Russia

City Clinical Hospital #15 named after O.M. Filatov Department of Health of Moscow

Moscow, Russia

City Clinical Hospital # 13/Gynecology Department # 1

Moscow, Russia

Clinical Hospital # 85 of the Federal Medical and Biological Agency/Central polyclinic

Moscow, Russia

Research Institute of Rheumatology named after V.A. Nasonova

Moscow, Russia

National Medical Research Center for Obstetrics, Gynecology and Perinatology named after V.I. Kulakov/Department of Aesthetic Gynecology and Rehabilitation

Moscow, Russia

Russian National Research Medical University named after N.I. Pirogov/Department of Obstetrics and Gynecology, Faculty of Medicine

Moscow, Russia

City Clinical Hospital # 1 named after. N.I. Pirogov of the Moscow City Health Department

Moscow, Russia

United hospital with clinic of the Administration of the President of the Russian Federation

Moscow, Russia

City Clinical Hospital # 67 named after L.A. Vorokhobov

Moscow, Russia

Moscow State Medical and Dental University named after A.I. Evdokimov/Department of Urologya

Moscow, Russia

Privolzhsky District Medical Center

Nizhny Novgorod, Russia

LLC "Urology Clinic # 1"

Penza, Russia

City Clinical Hospital

Pyatigorsk, Russia

Rostov Central District Hospital

Rostov, Russia

Clinical and Diagnostic Center "Health" in Rostov-on-Don

Rostov-on-Don, Russia

Rostov State Medical University/Department of Urology and Human Reproductive Health with a course of pediatric urology-andrology

Rostov-on-Don, Russia

Ryazan State Medical University named after Academician I.P. Pavlov/Department of Urology with a course of surgical diseases

Ryazan, Russia

LLC "Medical Center Capital-Polis"

Saint Petersburg, Russia

City Geriatric Medical and Social Center

Saint Petersburg, Russia

LLC "BioTechService"

Saint Petersburg, Russia

City clinic # 44

Saint Petersburg, Russia

All-Russian Center for Emergency and Radiation Medicine named after A.M. Nikiforov/Urology department

Saint Petersburg, Russia

St. Luke's Clinical Hospital

Saint Petersburg, Russia

Llc "Medical Clinic"

Saint Petersburg, Russia

Medical and sanitary unit No. 70 - branch of the St. Petersburg State Unitary Enterprise of Passenger Road Transport

Saint Petersburg, Russia

City Polyclinic # 112

Saint Petersburg, Russia

LLC "Research Center Eco-Safety"

Saint Petersburg, Russia

LLC "Zvezdnaya Clinic"

Saint Petersburg, Russia

City Hospital # 33

Saint Petersburg, Russia

LLC "New clinic "ABIA"

Saint Petersburg, Russia

LLC "Medical Center "PRIME ROSE"

Saint Petersburg, Russia

City Hospital # 15

Saint Petersburg, Russia

Research Institute of Obstetrics, Gynecology and Reproductology named after D.O. Ott/Department of Gynecology and Endocrinology

Saint Petersburg, Russia

City Pokrovskaya Hospital/Department of Urology

Saint Petersburg, Russia

City Polyclinic # 3

Saint Petersburg, Russia

City Polyclinic # 4

Saint Petersburg, Russia

LLC "Health Formula"

Semiluki, Russia

Sertolovo City Hospital

Sertolovo, Russia

LLC "Uromed"

Smolensk, Russia

Siberian State Medical University/Faculty clinics of Siberian State Medical University

Tomsk, Russia

Tver State Medical University/Department of Obstetrics and Gynecology

Tver', Russia

Voronezh State Medical University named after N.N. Burdenko/Department of Urology

Voronezh, Russia

Vsevolozhsk Clinical Interdistrict Hospital/Center for Outpatient Surgery

Vsevolozhsk, Russia

LLC "Clinic of Modern Medicine Dr. Bogorodskaya"

Yaroslavl, Russia

LLC "Medical Center for Diagnosis and Prevention Plus"

Yaroslavl, Russia

Regional Clinical Hospital/Urology department

Yaroslavl, Russia

Clinical Research Directory

Clinical Trial of the Efficacy and Safety of Raphamin in Prevention of Recurrences of Chronic Bacterial Cystitis

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (49)