Home › Trials › NCT06284265

Preventing Recurrences of Chronic Bacterial Cystitis with Raphamin

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

Phase 3 Interventional Materia Medica Holding · NCT06284265

This study is testing if a new medication called Raphamin can help women with chronic bacterial cystitis avoid future infections.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment632 (estimated)
Ages18 Years and up
SexFemale
SponsorMateria Medica Holding Industry-sponsored
Locations57 sites (Irkutsk and 56 other locations)
Trial IDNCT06284265 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of Raphamin in preventing recurrences of chronic bacterial cystitis in female outpatients aged 18 and older. The study is designed as a double-blind, placebo-controlled, randomized trial, where participants will be assigned to receive either Raphamin or a placebo alongside Phosphomycin. Patients will undergo assessments of their symptoms and undergo various tests, including urinalysis and ultrasound examinations, to monitor their condition. The trial aims to enroll at least 190 patients to gather sufficient data on the treatment's effectiveness.

Who should consider this trial

Good fit: Ideal candidates are female patients aged 18 years and older with a confirmed diagnosis of chronic bacterial cystitis experiencing severe symptoms.

Not a fit: Patients with urinary tract obstructions, urolithiasis, or other significant urinary tract disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the frequency of cystitis recurrences in affected patients.

How similar studies have performed: Other studies have shown promise in treating chronic bacterial cystitis with similar approaches, but the specific use of Raphamin is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Irkutsk and 56 other locations

+7 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Cystitis ChronicCystitis BacterialRecurrence of Chronic Bacterial Cystitis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.