nctId: NCT06284265 id: MMH-407-007 briefTitle: Clinical Trial of the Efficacy and Safety of Raphamin in Prevention of Recurrences of Chronic Bacterial Cystitis overallStatus: RECRUITING date: 2023-10-16 date: 2026-12-31 date: 2026-12-31 date: 2024-02-28 date: 2024-04-19 name: Materia Medica Holding class: INDUSTRY briefSummary: Clinical Trial of the Efficacy and Safety of Raphamin in Prevention of Recurrences of Chronic Bacterial Cystitis conditions: Cystitis Chronic conditions: Cystitis Bacterial conditions: Recurrence of Chronic Bacterial Cystitis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 632 type: ESTIMATED name: Raphamin name: Placebo measure: Time to the first recurrence of chronic bacterial cystitis measure: Percentage of patients with a reduction of recurrences of chronic bacterial cystitis measure: Average duration of episodes of recurrences of chronic bacterial cystitis measure: Average number of recurrences of chronic bacterial cystitis measure: Severity of chronic bacterial cystitis recurrences measure: Change in the severity of chronic bacterial cystitis recurrences measure: VAS score at the end of the follow-up period measure: The Presence of Adverse Events (AEs). measure: Changes in Vital Signs (Blood Pressure measured in mm Hg) measure: Changes in Vital Signs (Pulse Rate (Heart Rate) measured in beats per minute) measure: Changes in Vital Signs (Respiration Rate (Breathing Rate) measured in breaths per minute) measure: Proportion of patients with clinically significant laboratory abnormalities sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Scientific Center for Family Health and Human Reproduction Problems/Reproductive Health Department status: RECRUITING city: Irkutsk zip: 664003 country: Russian Federation name: Larisa Suturina, Prof. role: CONTACT name: Larisa Suturina, Prof. role: PRINCIPAL_INVESTIGATOR lat: 52.29778 lon: 104.29639 facility: Kazan State Medical University/Professor's clinic status: NOT_YET_RECRUITING city: Kazan zip: 420012 country: Russian Federation name: Ruslan Fatykhov, MD, PhD role: CONTACT name: Ruslan Fatykhov, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 55.78874 lon: 49.12214 facility: LLC "Fenareta" Women's and Men's Health Clinic" status: RECRUITING city: Kemerovo zip: 650000 country: Russian Federation name: Natalia Artymuk, Prof. role: CONTACT name: Natalia Artymuk, Prof. role: PRINCIPAL_INVESTIGATOR lat: 55.33333 lon: 86.08333 facility: City Clinical Hospital #15 named after O.M. Filatov Department of Health of Moscow status: RECRUITING city: Moscow zip: 111539 country: Russian Federation name: Vladimir Kuzmin, Prof. role: CONTACT name: Vladimir Kuzmin, Prof. role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 facility: City Clinical Hospital # 13/Gynecology Department # 1 status: RECRUITING city: Moscow zip: 115280 country: Russian Federation name: Felix Grigoryan, PhD role: CONTACT name: Felix Grigoryan, PhD role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 facility: Clinical Hospital # 85 of the Federal Medical and Biological Agency/Central polyclinic status: RECRUITING city: Moscow zip: 115409 country: Russian Federation name: Sergey Levakov, Prof. role: CONTACT name: Sergey Levakov, Prof. role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 facility: Research Institute of Rheumatology named after V.A. Nasonova status: RECRUITING city: Moscow zip: 115522 country: Russian Federation name: Victoria Gelashvili, MD role: CONTACT name: Victoria Gelashvili, MD role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 facility: National Medical Research Center for Obstetrics, Gynecology and Perinatology named after V.I. Kulakov/Department of Aesthetic Gynecology and Rehabilitation status: RECRUITING city: Moscow zip: 117198 country: Russian Federation name: Inna Apolikhina, Prof. role: CONTACT name: Inna Apolikhina, Prof. role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 facility: Peoples' Friendship University of Russia/Department of Obstetrics and Gynecology with a course in perinatology status: WITHDRAWN city: Moscow zip: 117198 country: Russian Federation lat: 55.75222 lon: 37.61556 facility: Russian National Research Medical University named after N.I. Pirogov/Department of Obstetrics and Gynecology, Faculty of Medicine status: RECRUITING city: Moscow zip: 117997 country: Russian Federation name: Yulia Dobrokhotova, Prof. role: CONTACT name: Yulia Dobrokhotova, Prof. role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 facility: City Clinical Hospital # 1 named after. N.I. Pirogov of the Moscow City Health Department status: RECRUITING city: Moscow zip: 119049 country: Russian Federation name: Sergey Kotov, PhD, MD role: CONTACT name: Sergey Kotov, PhD, MD role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 facility: United hospital with clinic of the Administration of the President of the Russian Federation status: NOT_YET_RECRUITING city: Moscow zip: 119285 country: Russian Federation name: Nikolay Keshishev, MD, PhD role: CONTACT name: Nikolay Keshishev, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 facility: City Clinical Hospital # 67 named after L.A. Vorokhobov status: NOT_YET_RECRUITING city: Moscow zip: 121423 country: Russian Federation name: Olga Perevozkina, MD, PhD role: CONTACT name: Olga Perevozkina, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 facility: JSC "MEDSI Group of Companies" status: WITHDRAWN city: Moscow zip: 123056 country: Russian Federation lat: 55.75222 lon: 37.61556 facility: Moscow State Medical and Dental University named after A.I. Evdokimov/Department of Urologya status: RECRUITING city: Moscow zip: 127473 country: Russian Federation name: Dmitry Pushkar, Prof. role: CONTACT name: Dmitry Pushkar, Prof. role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 facility: Privolzhsky District Medical Center status: RECRUITING city: Nizhny Novgorod zip: 603001 country: Russian Federation name: Vagif Atduev, Prof. role: CONTACT name: Vagif Atduev Vagif, Prof. role: PRINCIPAL_INVESTIGATOR lat: 56.32867 lon: 44.00205 facility: National Medical Research Center for Radiology/Research Institute of Urology and Interventional Radiology named after. N.A. Lopatkin status: NOT_YET_RECRUITING city: Obninsk zip: 105425 country: Russian Federation name: Tatyana Perepanova, Prof. role: CONTACT name: Tatyana Perepanova, Prof. role: PRINCIPAL_INVESTIGATOR lat: 55.09681 lon: 36.61006 facility: City Clinical Hospital status: NOT_YET_RECRUITING city: Pyatigorsk zip: 357500 country: Russian Federation name: Alexander Bardin, MD role: CONTACT name: Alexander Bardin, MD role: PRINCIPAL_INVESTIGATOR lat: 44.04861 lon: 43.05944 facility: Clinical and Diagnostic Center "Health" in Rostov-on-Don status: RECRUITING city: Rostov-on-Don zip: 344011 country: Russian Federation name: Igor Aboyan, Prof. role: CONTACT name: Igor Aboyan, Prof. role: PRINCIPAL_INVESTIGATOR lat: 47.23135 lon: 39.72328 facility: Rostov State Medical University/Department of Urology and Human Reproductive Health with a course of pediatric urology-andrology status: RECRUITING city: Rostov-on-Don zip: 344022 country: Russian Federation name: Mikhail Kogan, Prof. role: CONTACT name: Mikhail Kogan, Prof. role: PRINCIPAL_INVESTIGATOR lat: 47.23135 lon: 39.72328 facility: Rostov Central District Hospital status: NOT_YET_RECRUITING city: Rostov zip: 152155 country: Russian Federation name: Ariz Gyulmamedov, MD role: CONTACT name: Ariz Gyulmamedov, MD role: PRINCIPAL_INVESTIGATOR lat: 57.1914 lon: 39.41394 facility: JSC "Polyclinic Complex" status: WITHDRAWN city: Saint Petersburg zip: 190013 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: LLC "Medical Center Capital-Polis" status: NOT_YET_RECRUITING city: Saint Petersburg zip: 190013 country: Russian Federation name: Dmitry Gorelov, MD role: CONTACT name: Dmitry Gorelov, MD role: PRINCIPAL_INVESTIGATOR lat: 59.93863 lon: 30.31413 facility: LLC "BioTechService" status: RECRUITING city: Saint Petersburg zip: 190121 country: Russian Federation name: Alexander Parshin, PhD role: CONTACT name: Alexander Parshin, PhD role: PRINCIPAL_INVESTIGATOR lat: 59.93863 lon: 30.31413 facility: City clinic # 44 status: NOT_YET_RECRUITING city: Saint Petersburg zip: 192071 country: Russian Federation name: Farzali Farzaliev, MD role: CONTACT name: Farzali Farzaliev, MD role: PRINCIPAL_INVESTIGATOR lat: 59.93863 lon: 30.31413 facility: All-Russian Center for Emergency and Radiation Medicine named after A.M. Nikiforov/Urology department status: RECRUITING city: Saint Petersburg zip: 194044 country: Russian Federation name: Vladislav Grigoriev, PhD role: CONTACT name: Vladislav Grigoriev, PhD role: PRINCIPAL_INVESTIGATOR lat: 59.93863 lon: 30.31413 facility: St. Luke's Clinical Hospital status: RECRUITING city: Saint Petersburg zip: 194044 country: Russian Federation name: Orlov Igor, PhD role: CONTACT name: Orlov Igor, PhD role: PRINCIPAL_INVESTIGATOR lat: 59.93863 lon: 30.31413 facility: City Multidisciplinary Hospital # 2/Urology department status: WITHDRAWN city: Saint Petersburg zip: 194354 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Llc "Medical Clinic" status: RECRUITING city: Saint Petersburg zip: 194356 country: Russian Federation name: Maxim Bushara, MD role: CONTACT name: Maxim Bushara, MD role: PRINCIPAL_INVESTIGATOR lat: 59.93863 lon: 30.31413 facility: Medical and sanitary unit No. 70 - branch of the St. Petersburg State Unitary Enterprise of Passenger Road Transport status: RECRUITING city: Saint Petersburg zip: 195197 country: Russian Federation name: Vadim Zubarev, PhD, MD role: CONTACT name: Vadim Zubarev, PhD, MD role: PRINCIPAL_INVESTIGATOR lat: 59.93863 lon: 30.31413 facility: LLC "Research Center Eco-Safety" status: TERMINATED city: Saint Petersburg zip: 196143 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Jsc "Northwestern Center of Evidence-Based Medicine" status: WITHDRAWN city: Saint Petersburg zip: 196158 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: City Hospital # 15 status: NOT_YET_RECRUITING city: Saint Petersburg zip: 198205 country: Russian Federation name: Konstantin Dunets, MD role: CONTACT name: Konstantin Dunets, MD role: PRINCIPAL_INVESTIGATOR lat: 59.93863 lon: 30.31413 facility: Research Institute of Obstetrics, Gynecology and Reproductology named after D.O. Ott/Department of Gynecology and Endocrinology status: RECRUITING city: Saint Petersburg zip: 199034 country: Russian Federation name: Maria Yarmolinskaya, Prof. role: CONTACT name: Maria Yarmolinskaya, Prof. role: PRINCIPAL_INVESTIGATOR lat: 59.93863 lon: 30.31413 facility: City Pokrovskaya Hospital/Department of Urology status: RECRUITING city: Saint Petersburg zip: 199106 country: Russian Federation name: Andrey Gorelov, Prof. role: CONTACT name: Andrey Gorelov, Prof. role: PRINCIPAL_INVESTIGATOR lat: 59.93863 lon: 30.31413 facility: Sertolovo City Hospital status: NOT_YET_RECRUITING city: Sertolovo zip: 188650 country: Russian Federation name: Alexander Shvets, MD role: CONTACT name: Alexander Shvets, MD role: PRINCIPAL_INVESTIGATOR lat: 60.1444 lon: 30.20165 facility: Siberian State Medical University/Faculty clinics of Siberian State Medical University status: NOT_YET_RECRUITING city: Tomsk zip: 634050 country: Russian Federation name: Victor Latypov, MD, PhD role: CONTACT name: Victor Latypov, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 56.49771 lon: 84.97437 facility: Bashkir State Medical University/Department of Obstetrics and Gynecology # 1 status: WITHDRAWN city: Ufa zip: 450008 country: Russian Federation lat: 54.74306 lon: 55.96779 facility: Voronezh State Medical University named after N.N. Burdenko/Department of Urology status: RECRUITING city: Voronezh zip: 394036 country: Russian Federation name: Andrey Kuzmenko, Prof. role: CONTACT name: Andrey Kuzmenko, Prof. role: PRINCIPAL_INVESTIGATOR lat: 51.67204 lon: 39.1843 facility: Vsevolozhsk Clinical Interdistrict Hospital/Center for Outpatient Surgery status: RECRUITING city: Vsevolozhsk zip: 188643 country: Russian Federation name: Nikolay Kanareikin, MD role: CONTACT name: Nikolay Kanareikin, MD role: PRINCIPAL_INVESTIGATOR lat: 60.01512 lon: 30.67314 facility: Yaroslavl State Medical University/Department of Urology and Nephrology status: NOT_YET_RECRUITING city: Yaroslavl zip: 150000 country: Russian Federation name: Igor Shormanov, Prof. role: CONTACT name: Igor Shormanov, Prof. role: PRINCIPAL_INVESTIGATOR lat: 57.62987 lon: 39.87368 facility: LLC "Clinic of Modern Medicine Dr. Bogorodskaya" status: NOT_YET_RECRUITING city: Yaroslavl zip: 150001 country: Russian Federation name: Andrey Soloviev, MD, PhD role: CONTACT name: Andrey Soloviev, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 57.62987 lon: 39.87368 facility: LLC "Medical Center for Diagnosis and Prevention Plus" status: RECRUITING city: Yaroslavl zip: 150040 country: Russian Federation name: Svetlana Isakova, MD role: CONTACT name: Svetlana Isakova, MD role: PRINCIPAL_INVESTIGATOR lat: 57.62987 lon: 39.87368 facility: Regional Clinical Hospital/Urology department status: RECRUITING city: Yaroslavl zip: 150062 country: Russian Federation name: Dmitry Komlev, PhD role: CONTACT name: Dmitry Komlev, PhD role: PRINCIPAL_INVESTIGATOR lat: 57.62987 lon: 39.87368 hasResults: False