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Multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of XC243 in patients with exacerbation of chronic cystitis. It is planned to include patients with chronic cystitis in 4 parallel groups, who will receive XC243 at a dose of 25 mg per day, 50 mg per day, 75 mg per day or placebo for 7-10 days. Efficacy will be assessed by time from first study treatment to resolution of the symptom "Pain, discomfort or burning when urination " assessed on a visual-analog scale (VAS).
The study will be conducted in 8 centers. The study will include the following periods: screening (1 day), treatment period (up to 10 days), follow-up period (7 days).
Upon completion of screening, patients will be randomized to 4 groups in the ratio 1:1:1:1: XC243 at a dose of 25 mg per day, 50 mg per day, 75 mg per day or placebo group.
Also, all patients will be prescribed furasidin daily at the same time, 2 capsules (total dose 100 mg) 3 times a day after meals. On day 8 the investigator will assess the symptoms of cystitis and decide whether to discontinue or prolong a course of therapy with XC243 and furasidin for up to 10 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XC243 25 mg | Experimental | XC243 25 mg single |
|
| XC243 50 mg | Experimental | XC243 50 mg single |
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| XC243 75 mg | Experimental | XC243 75 mg single |
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| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XC243 25 mg | Drug | Patients will receive the Investigated Product (IP) once in the morning at least 30 minutes before eating for 7-10 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time from the first dose of IP treatment until the symptom "Pain, discomfort or burning when urination " disappears (decreases). | Symptom disappears (decreases) criterion "Pain, discomfort or burning during urination "is considered to be the simultaneous fulfillment of the following conditions: Improvement to 1 point or less in VAS and Maintain VAS score of 1 point or less for 24 hours. Within 96 hours (4 days) after the first dose of the IP assessment of the symptom "Pain, discomfort or burning when urinating" will be conducted by the patient after each urination. After 96 hours (from day 5) evaluation this symptom will be carried out 2 times a day (8-00 to 10-00 hours and from 20-00 to 22-00 hours over time). Superiority over placebo will be considered established if difference in mean between groups (XC243 - placebo) by symptom reduction time would be greater than 11 hours at the time of treatment evaluation. | Day 1 - Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of the symptom "Pain, discomfort or burning with urination "as per VAS | Severity of the symptom "Pain, discomfort or burning with urination "as per VAS to Visit 2 (Day 2), Visit 3 (Day 5), Visit 4 (Day 8), End of therapy Visit (Day 11) | Day 1 - Day 11 |
| Dynamics of the symptom "Pain, discomfort or burning when urinating" by VAS. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vladimir Nebolsin | Contact | +79175584626 | nve1970@mail.ru |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unimed-S Cjsc | Moscow | 119571 | Russia |
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| ID | Term |
|---|---|
| D003556 | Cystitis |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Parallel proup
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Blinding was carried out by using placebo equivalent to XC243 tablets without active pharmaceutical ingredients (API) and the corresponding labeling of the ID.
| XC243 50 mg | Drug | Patients will receive the IP once in the morning at least 30 minutes before eating for 7-10 days |
|
| XC243 75 mg | Drug | Patients will receive the IP once in the morning at least 30 minutes before eating for 7-10 days |
|
| Placebo | Drug | Patients will receive the IP once in the morning at least 30 minutes before eating for 7-10 days |
|
Dynamics of the symptom "Pain, discomfort or burning when urinating" by VAS to End of therapy Visit |
| Day 1 - Day 11 |
| Assessment of disease symptoms by Acute Cystitis Symptom Score (ACSS). | ACSS assessment of disease symptoms to Visit 2 (Day 2), Visit 3 (Day 5), Visit 4 (Day 8), End of therapy Visit (Day 11) | Day 1 - Day 11 |
| Dynamics of typical symptoms according to the ACSS scale | Dynamics of typical symptoms of the disease according to the ACSS scale to Visit 2 (Day 2), Visit 3 (Day 5), Visit 4 (Day 8), End of therapy Visit (Day 11) | Day 1 - Day 11 |
| Dynamics of quality of life according to the ACSS scale | Dynamics of quality of life according to the ACSS scale to Visit 2 (Day 2), Visit 3 (Day 5), Visit 4 (Day 8), End of therapy Visit (Day 11) | Day 1 - Day 11 |
| Frequency of patients with disappearance of all typical symptoms diseases | Frequency of patients with disappearance of all typical symptoms diseases (ACSS score 0) to Visit 2 (Day 2), Visit 3 (Day 5), Visit 4 (Day 8), End of therapy Visit (Day 11) | Day 1 - Day 11 |
| Time to disappearance of typical disease symptoms for each symptom by ACSS | Time to disappearance of typical disease symptoms (score 0 on the ACSS scale) for each symptom to Visit 2 (Day 2), Visit 3 (Day 5), Visit 4 (Day 8), End of therapy Visit (Day 11) | Day 1 - Day 11 |
| Frequency of patients with disappearance of the symptom "pain or urinary burning " by ACSS | Frequency of patients with disappearance of the symptom "pain or urinary burning "(ACSS score 0) to Visit 2 (Day 2), Visit 3 (Day 5), Visit 4 (Day 8), End of therapy Visit (Day 11) | Day 1 - Day 11 |
| Frequency of patients with disappearance of the symptom "pain or discomfort in the lower abdomen (suprapubic region) " by ACSS | Frequency of patients with disappearance of the symptom "pain or discomfort in the lower abdomen (suprapubic region) "(score 0 according to ACSS) to Visit 2 (Day 2), Visit 3 (Day 5), Visit 4 (Day 8), End of therapy Visit (Day 11) | Day 1 - Day 11 |
| Scale score by Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF Scale) | Scale score by PUF Scale to Visit 2 (Day 2), Visit 3 (Day 5), Visit 4 (Day 8), End of therapy Visit (Day 11) | Day 1 - Day 11 |
| Dynamics of symptoms of the disease according to the Diary patient. | Dynamics of symptoms of the disease according to the Diary patient to Visit 2 (Day 2), Visit 3 (Day 5), Visit 4 (Day 8), End of therapy Visit (Day 11) | Day 1 - Day 11 |
| Dynamics of the symptom "Pain or burning when urinating" according to VAS within first 24 hours post-dose | Dynamics of the symptom "Pain or burning when urinating" according to VAS within first 24 hours post-dose | Day 1 - Day 2 |
| Mean urinary frequency per day by Patient Diary | Mean urinary frequency per day by Patient Diary to Visit 2 (Day 2), Visit 3 (Day 5), Visit 4 (Day 8), End of therapy Visit (Day 11) | Day 1 - Day 11 |
| Assesment by Global Clinical Impression Scale score (CGI-i) | Patient's CGI-i score | Day 1 - Day 11 |
| Evaluation of the efficacy of therapy by 5 rating scale | Evaluation of the efficacy of therapy by 5 rating scale to Visit 2 (Day 2), Visit 3 (Day 5), Visit 4 (Day 8), End of therapy Visit (Day 11). This scale is assessed by the investigator, where 1 point - absence, 2 points - regression, 3 points - decrease in severity, 4 points - lack of positive dynamics, 5 points - increase in the main clinical symptoms | Day 1 - Day 11 |
| LLC "Research Center Eco-Safety" | Saint Petersburg | 191119 | Russia |
| St. Petersburg State Budgetary Healthcare Institution "City Polyclinic № 112" | Saint Petersburg | 195427 | Russia |
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| LLC "Research Center Eco-Safety" | Saint Petersburg | 196143 | Russia |
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| LLC "Clinic Zvezdnaya" | Saint Petersburg | 196158 | Russia |
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| North-West Center of Evidence-Based Medicine Jsc | Saint Petersburg | 196158 | Russia |
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| Prime Rose Medical Center LLC | Saint Petersburg | 197374 | Russia |
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| St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 4" | Saint Petersburg | 199178 | Russia |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |