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

NCT06284265 | Active Not Recruiting Phase 3

• 1 other identifier: MMH-407-007
• Study Type: interventional
• Target: 415
• Locations: 1 country
• Sites: 49

Brief Summary

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

Conditions

Cystitis Chronic; Cystitis Bacterial; Recurrence of Chronic Bacterial Cystitis

Outcome Measures

Primary Outcomes (1)

• Time to the first recurrence of chronic bacterial cystitis

  Criteria for the diagnosis of chronic bacterial cystitis recurrence are typical symptoms of exacerbation (acute cystitis): frequent urination with small volumes of urine; urgent urination (a sudden and uncontrollable urge to pass urine; feeling pain or burning when passing urine; feeling of incomplete bladder emptying after urination; pain or uncomfortable pressure in the lower abdomen (above the pubis); possible presence of blood in the urine (especially towards the end of urination). Criteria for the diagnosis of chronic bacterial cystitis are 2 and more recurrences during previous 6 months or 3 and more recurrences during previous 12 months.

  6 months

Secondary Outcomes (1)

• Percentage of patients with a reduction of recurrences of chronic bacterial cystitis

  6 months

Other Outcomes (10)

• Average duration of episodes of recurrences of chronic bacterial cystitis

  6 months

• Average number of recurrences of chronic bacterial cystitis

  6 months

• Severity of chronic bacterial cystitis recurrences

  6 months

Study Arms (2)

Raphamin

EXPERIMENTAL

Take orally, do not take with meals. Keep the tablets in the mouth until completely dissolved. On the first day of treatment, 8 tablets are taken according to the following scheme: 1 tablet every 30 minutes in the first 2 hours (a total of 5 tablets in 2 hours), then during the same day another 1 tablet is taken 3 times at regular intervals. On the 2nd day and then take 1 tablet 3 times a day. The duration of treatment is 10 days.

Drug: Raphamin

Placebo

PLACEBO COMPARATOR

Take orally, do not take with meals. Keep the tablets in the mouth until completely dissolved. Placebo is administered according to the Raphamin regimen for 10 days.

Drug: Placebo

Interventions

Raphamin DRUG

Tablet for oral use.

Also known as: MMH-407

Raphamin

Placebo DRUG

Tablet for oral use.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients aged 18 years and older.
• Patients with a confirmed diagnosis of chronic bacterial cystitis.
• 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.
• The first 48 hours from the onset of exacerbation) of chronic bacterial cystitis.
• Patients who agreed to use an acceptable method of contraception during the study (for women of reproductive potential).
• Availability of a signed patient information sheet and informed consent form for participation in the clinical trial.

You may not qualify if:

• Presence of urolithiasis, urinary tract obstruction, urothelial cancer, pelvic organ prolapse, neurogenic bladder disorders at the time of examination.
• Presence of malignant neoplasms of the urinary tract, ureter stone, more than 50 ml of residual urine in the bladder, confirmed by ultrasound examination.
• Suspicion of bladder tuberculosis.
• Presence of indications for hospitalization due to a serious condition, macrohematuria, complicated cystitis.
• 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).
• Unstable angina pectoris or myocardial infarction within the previous 6 months.
• Chronic kidney disease (classes С3-5 А3).
• Hepatic impairment (Child-Pugh class C).
• Patients who require medicinal products prohibited for use in this study.
• Exacerbation or decompensation of chronic conditions affecting the patient's ability to participate in the clinical trial.
• Malabsorption syndrome, including congenital or acquired lactase deficiency or other disaccharidase insufficiency, galactosemia.
• Hypersensitivity to any component of the medicinal products used in the treatment.
• Pregnancy, breastfeeding; childbirth less than 3 months prior to study enrollment, unwillingness to comply with contraceptive methods during the study.
• The medications listed in the Prohibited Concomitant Medication section were administered within 4 weeks prior to enrollment.
• 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.

Sponsors & Collaborators

• Materia Medica Holding: lead

Study Sites (49)

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

Irkutsk, 664003, Russia

Location

Kazan State Medical University/Professor's clinic

Kazan', 420012, Russia

Location

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

Kemerovo, 650000, Russia

Location

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

Moscow, 111539, Russia

Location

City Clinical Hospital # 13/Gynecology Department # 1

Moscow, 115280, Russia

Location

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

Moscow, 115409, Russia

Location

Research Institute of Rheumatology named after V.A. Nasonova

Moscow, 115522, Russia

Location

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

Moscow, 117198, Russia

Location

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

Moscow, 117997, Russia

Location

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

Moscow, 119049, Russia

Location

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

Moscow, 119285, Russia

Location

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

Moscow, 121423, Russia

Location

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

Moscow, 127473, Russia

Location

Privolzhsky District Medical Center

Nizhny Novgorod, 603001, Russia

Location

LLC "Urology Clinic # 1"

Penza, 440000, Russia

Location

City Clinical Hospital

Pyatigorsk, 357500, Russia

Location

Rostov Central District Hospital

Rostov, 152155, Russia

Location

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

Rostov-on-Don, 344011, Russia

Location

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

Rostov-on-Don, 344022, Russia

Location

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

Ryazan, 390026, Russia

Location

LLC "Medical Center Capital-Polis"

Saint Petersburg, 190013, Russia

Location

City Geriatric Medical and Social Center

Saint Petersburg, 190103, Russia

Location

LLC "BioTechService"

Saint Petersburg, 190121, Russia

Location

City clinic # 44

Saint Petersburg, 192071, Russia

Location

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

Saint Petersburg, 194044, Russia

Location

St. Luke's Clinical Hospital

Saint Petersburg, 194044, Russia

Location

Llc "Medical Clinic"

Saint Petersburg, 194356, Russia

Location

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

Saint Petersburg, 195197, Russia

Location

City Polyclinic # 112

Saint Petersburg, 195427, Russia

Location

LLC "Research Center Eco-Safety"

Saint Petersburg, 196143, Russia

Location

LLC "Zvezdnaya Clinic"

Saint Petersburg, 196158, Russia

Location

City Hospital # 33

Saint Petersburg, 196653, Russia

Location

LLC "New clinic "ABIA"

Saint Petersburg, 197371, Russia

Location

LLC "Medical Center "PRIME ROSE"

Saint Petersburg, 197374, Russia

Location

City Hospital # 15

Saint Petersburg, 198205, Russia

Location

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

Saint Petersburg, 199034, Russia

Location

City Pokrovskaya Hospital/Department of Urology

Saint Petersburg, 199106, Russia

Location

City Polyclinic # 3

Saint Petersburg, 199155, Russia

Location

City Polyclinic # 4

Saint Petersburg, 199178, Russia

Location

LLC "Health Formula"

Semiluki, 396907, Russia

Location

Sertolovo City Hospital

Sertolovo, 188650, Russia

Location

LLC "Uromed"

Smolensk, 214031, Russia

Location

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

Tomsk, 634050, Russia

Location

Tver State Medical University/Department of Obstetrics and Gynecology

Tver', 170100, Russia

Location

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

Voronezh, 394036, Russia

Location

Vsevolozhsk Clinical Interdistrict Hospital/Center for Outpatient Surgery

Vsevolozhsk, 188643, Russia

Location

LLC "Clinic of Modern Medicine Dr. Bogorodskaya"

Yaroslavl, 150001, Russia

Location

LLC "Medical Center for Diagnosis and Prevention Plus"

Yaroslavl, 150040, Russia

Location

Regional Clinical Hospital/Urology department

Yaroslavl, 150062, Russia

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 28, 2024
• Study Start: October 16, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

RU (49)