Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Hope for women with chronic cystitis: raphamin trial aims to stop recurring UTIs

NCT ID NCT06284265

Prevention Sponsor: Materia Medica Holding Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 trial tests whether Raphamin, an oral tablet, can prevent repeat episodes of chronic bacterial cystitis (a type of urinary tract infection) in women. About 415 women with frequent infections will take either Raphamin or a placebo for six months. The main goal is to see how long it takes for the first recurrence to happen, and whether the drug reduces the number of flare-ups overall.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Raphamin (also known as MMH-407), a tablet taken by mouth
What this could lead to
If it works, this could offer a new way to prevent frequent, painful urinary tract infections in women with chronic cystitis.
What could go wrong
This is a Phase 3 trial, but results are not yet available. The drug may not reduce recurrences better than a placebo, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

415 people

The number who actually took part.

Started

Oct 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Cystitis bacterial are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

chronic cystitis cystitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cystitis bacterial Cystitis chronic Recurrence of chronic bacterial cystitis

Contacts and locations

Locations

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

    Saint Petersburg, 194044, Russia

  • City Clinical Hospital

    Pyatigorsk, 357500, Russia

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

    Moscow, 119049, Russia

  • City Clinical Hospital # 13/Gynecology Department # 1

    Moscow, 115280, Russia

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

    Moscow, 121423, Russia

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

    Moscow, 111539, Russia

  • City Geriatric Medical and Social Center

    Saint Petersburg, 190103, Russia

  • City Hospital # 15

    Saint Petersburg, 198205, Russia

  • City Hospital # 33

    Saint Petersburg, 196653, Russia

  • City Pokrovskaya Hospital/Department of Urology

    Saint Petersburg, 199106, Russia

  • City Polyclinic # 112

    Saint Petersburg, 195427, Russia

  • City Polyclinic # 3

    Saint Petersburg, 199155, Russia

  • City Polyclinic # 4

    Saint Petersburg, 199178, Russia

  • City clinic # 44

    Saint Petersburg, 192071, Russia

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

    Moscow, 115409, Russia

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

    Rostov-on-Don, 344011, Russia

  • Kazan State Medical University/Professor's clinic

    Kazan', 420012, Russia

  • LLC "BioTechService"

    Saint Petersburg, 190121, Russia

  • LLC "Clinic of Modern Medicine Dr. Bogorodskaya"

    Yaroslavl, 150001, Russia

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

    Kemerovo, 650000, Russia

  • LLC "Health Formula"

    Semiluki, 396907, Russia

  • LLC "Medical Center "PRIME ROSE"

    Saint Petersburg, 197374, Russia

  • LLC "Medical Center Capital-Polis"

    Saint Petersburg, 190013, Russia

  • LLC "Medical Center for Diagnosis and Prevention Plus"

    Yaroslavl, 150040, Russia

  • LLC "New clinic "ABIA"

    Saint Petersburg, 197371, Russia

  • LLC "Research Center Eco-Safety"

    Saint Petersburg, 196143, Russia

  • LLC "Urology Clinic # 1"

    Penza, 440000, Russia

  • LLC "Uromed"

    Smolensk, 214031, Russia

  • LLC "Zvezdnaya Clinic"

    Saint Petersburg, 196158, Russia

  • Llc "Medical Clinic"

    Saint Petersburg, 194356, Russia

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

    Saint Petersburg, 195197, Russia

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

    Moscow, 127473, Russia

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

    Moscow, 117198, Russia

  • Privolzhsky District Medical Center

    Nizhny Novgorod, 603001, Russia

  • Regional Clinical Hospital/Urology department

    Yaroslavl, 150062, Russia

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

    Saint Petersburg, 199034, Russia

  • Research Institute of Rheumatology named after V.A. Nasonova

    Moscow, 115522, Russia

  • Rostov Central District Hospital

    Rostov-on-Don, 152155, Russia

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

    Rostov-on-Don, 344022, Russia

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

    Moscow, 117997, Russia

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

    Ryazan, 390026, Russia

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

    Irkutsk, 664003, Russia

  • Sertolovo City Hospital

    Sertolovo, 188650, Russia

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

    Tomsk, 634050, Russia

  • St. Luke's Clinical Hospital

    Saint Petersburg, 194044, Russia

  • Tver State Medical University/Department of Obstetrics and Gynecology

    Tver', 170100, Russia

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

    Moscow, 119285, Russia

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

    Voronezh, 394036, Russia

  • Vsevolozhsk Clinical Interdistrict Hospital/Center for Outpatient Surgery

    Vsevolozhsk, 188643, Russia

More trials for these conditions

Other studies related to the condition(s) this trial covers.