A Phase 3 interventional study of Raphamin and Placebo in Cystitis Chronic, Cystitis Bacterial and Recurrence of Chronic Bacterial Cystitis, sponsored by Materia Medica Holding. Active, not recruiting at 49 sites in Russia. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-13.
Sponsored by Materia Medica Holding · Phase 3, Interventional, and Prevention
Clinical Trial of the Efficacy and Safety of Raphamin in Prevention of Recurrences of Chronic Bacterial Cystitis
Trial design: double blind, placebo-controlled, randomized in parallel groups clinical trial.
The trial includes female outpatients aged 18 years or older with typical symptoms of chronic bacterial cystitis. The severity of typical symptoms of recurrence (exacerbation) should be 7 points or more according to the subscale "Typical symptoms" of the scale "Acute Cystitis Symptom Scale" (ACSS).
At Visit 1 (Day 1), after signing the patient information sheet and the informed consent form for participation in the clinical trial, complaints and medical history are collected, a physical examination is performed, and the severity of typical symptoms of cystitis is assessed using ACSS, collection of urine biosamples for urine analysis with microscopy and bacteriological examination (for identification the sensitivity of microorganisms to antibiotics), ultrasound examination of the urinary system (kidneys, bladder), and concomitant therapy is recorded.
Urinalysis, general and biochemical blood tests are planned in at least 190 patients.
If the patient meets inclusion criteria and does not meets exclusion inclusion criteria at Visit 1 (Day 1), the patient is randomized to one of two groups: patients of Group 1 take Phosphomycin (3 g once) and Raphamin according to the therapeutic and preventive regimen for 10 days; patients of Group 2 use Phosphomycin (3 g once) and Placebo according to the Raphamin regimen for 10 days.
If there is no effect from treatment within 48 hours or phosphomycin-resistant strains are detected, the physician conducts unscheduled visit and gives the patient an alternative drug Cefixime (400 mg). Cefixime is taken 1 times a day at a dose of 400 mg for 5 days or more (the duration of the course is determined by the physician).
All patients are provided with Phosphomycin, if resistance to it is detected - with alternative antibiotic Cefixime.
If microorganisms resistant to both Phosphomycin and Cefixime are detected, the patient is excluded from the trial, and the physician prescribes a treatment strategy in accordance with current standards.
In Electronic Patient Diary (EPD) the patient records the severity of typical cystitis symptoms using ACSS once a day at approximately the same time. Symptoms are recorded in the EPD from the patient's enrollment until Visit 2 (within 10 days of study drug administration), as well as during 10 days of treatment for each subsequent relapse (exacerbation).
In addition, any possible deterioration of the patient's condition (if applicable) is recorded in EDP to assess safety and record adverse events. The study physician instructs patients to complete the diary.
The first ACSS marks in the EDP are made by patient together with physician at Visit 1. EDP is available for filling throughout the patient's participation in the study. Once a week, the patients get SMS reminder: "If you have symptoms of the disease, enter them in the diary and contact the study physician. Don't forget to take your medication." In total, patient's follow-up lasts for 24 weeks. In the process of treatment and observation, 4 visits are scheduled: at day 1 (Visit 1) and day 11 (Visit 2), then at weeks 12 and 24 (Visits 3, 4). Visits 1, 2 and 4 are face-to-face (patient visits trial site); physician conducts physical examination, records symptoms and concomitant therapy, and checks the EPD. At Visit 2 (Day 11+3), the physician gives Phosphomycin/Cefixime and a study drug to patient, to treat a possible subsequent recurrence of cystitis. Blood and urine biosamples are taken from the patient who signed the ICF for taking biological samples (for safety assessment). The study drug received by the patient at Visit 1 should be returned to assess the patient's adherence to the study treatment. Phosphomycin/Cefixime also returns.
Visit 3 (Week 12 ± 3 days) is conducted by correspondence (telephone), in order to interview the patient about her condition.
In case of new recurrence of cystitis, patient contacts with trial physician by phone. On the basis of complaints and symptoms, physician makes conclusion about the onset of chronic cystitis recurrence. Patient completes ACSS in EPD. For a recurrence of cystitis, patient takes Phosphomycin (or Cefixime) and trial product (Raphamin/Placebo for 10 days). At the end of 10 days of treatment, an unscheduled face-to-face visit takes place (Day 11+3 days after the onset of recurrence), at which the patient returns the trial product and Phosphomycin/Cefixime, then the physician dispenses a new pack of trial product and Phosphomycin (or Cefixime) to treat a possible new recurrence of cystitis.
Visit 4 (Week 24 ± 3 days) is the final one; complaints are assessed, the patient undergoes a physical examination, returns the trial product and fills in a visual analogue scale (VAS), which assesses the degree of patient satisfaction with the therapy.
69 studies on the registry are indexed under Cystitis; 17 are open to participants now.
This study's enrollment of 415 is above the median of 112 across 50 interventional studies indexed under Cystitis.
Browse Cystitis studies →Materia Medica Holding is the lead sponsor of 43 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Tablet for oral use.
Also known as: MMH-407
Tablet for oral use.
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.
Time frame: 6 months
Percentage of patients with a reduction of recurrences of chronic bacterial cystitis
Percentage of patients with a reduction number of recurrences of chronic bacterial cystitis to one episode and less during 6 months of follow-up.
Time frame: 6 months
Average duration of episodes of recurrences of chronic bacterial cystitis
Average duration of episodes of recurrences of chronic bacterial cystitis after the start of study therapy at inclusion in the study, score 6 or less of typical symptoms of cystitis by the Acute Cystitis Symptom Score (according to the patient's diary).
Time frame: 6 months
Average number of recurrences of chronic bacterial cystitis
Average number of recurrences of chronic bacterial cystitis per patient during 6 months of follow-up.
Time frame: 6 months
Severity of chronic bacterial cystitis recurrences
Severity of chronic bacterial cystitis recurrences within 6 months of follow-up (as measured by the area under the curve for the total score of typical symptoms of cystitis on the Acute Cystitis Symptom Score (ACSS) during 10 days of treatment for each episode of recurrence). ACSS is an 18-item self-reporting questionnaire for clinical diagnosis and follow-up of acute uncomplicated cystitis in women (min 0, max 18 points; 6 typical symptoms are included: urinary frequency, urgent urination, burning feeling when urinating, incomplete bladder empting after urination, pain or uncomfortable pressure in the lower abdomen, visible blood in urine; each symptom is estimated from 0 to 3 points).
Time frame: 6 months
Change in the severity of chronic bacterial cystitis recurrences
Change in the severity of chronic bacterial cystitis recurrences during 6 months of follow-up compared to baseline.
Time frame: 6 months
VAS score at the end of the follow-up period
Visual Analogue Scale (VAS) is used to assess the degree of satisfaction with the treatment. Treatment satisfaction scores are ranged from 0 (no satisfaction with treatment) to 10 points (very significant treatment effect), such that a higher score indicates greater treatment efficacy.
Time frame: 6 months
The Presence of Adverse Events (AEs).
The presence and nature of adverse events, their intensity (severity), causal relationship to the study drug, outcome. Based on medical records.
Time frame: 6 months
Changes in Vital Signs (Blood Pressure measured in mm Hg)
Changes in Blood Pressure at the end of treatment of the initial recurrence of chronic cystitis.
Time frame: 6 months
Changes in Vital Signs (Pulse Rate (Heart Rate) measured in beats per minute)
Changes in Heart Rate at the end of treatment of the initial recurrence of chronic cystitis.
Time frame: 6 months
Changes in Vital Signs (Respiration Rate (Breathing Rate) measured in breaths per minute)
Changes in Respiratory Rate at the end of treatment of the initial recurrence of chronic cystitis. Based on medical records.
Time frame: 6 months
Proportion of patients with clinically significant laboratory abnormalities
Proportion of patients with clinically significant laboratory findings abnormalities at the end of treatment for initial recurrence of chronic cystitis.
Time frame: 6 months
This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: MMH-407