Study to Evaluate the Efficacy and Safety of XC243 in Patients With Exacerbation of Chronic Cystitis
NCT ID: NCT06391164
Last Updated: 2024-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
280 participants
INTERVENTIONAL
2024-04-30
2025-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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XC243 25 mg
XC243 25 mg single
XC243 25 mg
Patients will receive the Investigated Product (IP) once in the morning at least 30 minutes before eating for 7-10 days
XC243 50 mg
XC243 50 mg single
XC243 50 mg
Patients will receive the IP once in the morning at least 30 minutes before eating for 7-10 days
XC243 75 mg
XC243 75 mg single
XC243 75 mg
Patients will receive the IP once in the morning at least 30 minutes before eating for 7-10 days
Placebo
Placebo
Patients will receive the IP once in the morning at least 30 minutes before eating for 7-10 days
Interventions
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XC243 25 mg
Patients will receive the Investigated Product (IP) once in the morning at least 30 minutes before eating for 7-10 days
XC243 50 mg
Patients will receive the IP once in the morning at least 30 minutes before eating for 7-10 days
XC243 75 mg
Patients will receive the IP once in the morning at least 30 minutes before eating for 7-10 days
Placebo
Patients will receive the IP once in the morning at least 30 minutes before eating for 7-10 days
Eligibility Criteria
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Inclusion Criteria
2. Women aged 18 to 65 years inclusive at the time of signing the Informed IMP consent.
3. Established diagnosis of chronic bacterial cystitis (at least three relapses chronic cystitis within 12 months prior to screening or two cases within 6 months prior to screening, including relapse at study entry).
4. The presence of symptoms characteristic of exacerbation of chronic cystitis: pain syndrome (pain in lower abdomen, when urinating), dysuric symptoms (increased urination, pain or burning when urinating, urgency to urinate, feeling of incomplete emptying bladder).
5. The appearance of symptoms of exacerbation of chronic cystitis is not \> 48 hours prior to screening visit.
6. Severity of the symptom "Pain, discomfort or burning with urination "from 4 to 8 VAS points.
7. No therapy for current cystitis exacerbation (including phosphomycin and/or furasidin for the treatment of current exacerbation).
8. The patient's consent to refrain from drinking alcoholic beverages during the period of participation in study.
9. Patient consent to use reliable methods contraception throughout the study and through 3 weeks after its end.
Exclusion Criteria
2. Hypersensitivity to furasidine and/or any of the excipients concomitant medication.
3. Chronic recurrent cystitis due to infections, sexually transmitted diseases (STIs): gonorrhea, chlamydia, ureaplasmosis, mycoplasmosis, herpes, candidiasis, gardnerellosis, history of trichomoniasis.
4. Chronic recurrent cystitis of viral etiology (caused by adenovirus, cytomegalovirus, virus human papillomavirus herpes).
5. Axillary body temperature ≥ 38 ° C at the screening visit.
6. Presence of menstruation at randomization or estimated onset of menstruation during the period therapy.
7. Pain in the lumbar region.
8. Itching and abundant vaginal discharge and/or purulent discharge from the genitourinary tract.
9. History and/or findings of genitourinary anatomical disorders ultrasound examination (hydronephrosis, sclerosis of the bladder neck, cystocele, descent uterus, paraurethral cyst).
10. Presence of inflammatory diseases of the sexual system (vaginitis, colpitis, cervicitis).
11. Kidney and urinary tract diseases (including urolithiasis), with the exception of chronic cystitis, with a history that, in the opinion of study doctor, may affect the course and results of the clinical study.
12. Chronic renal failure.
13. Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus.
14. History of pseudomembranous colitis.
15. Signs of macrohematuria (admixture of blood in the urine, discoloration of the urine).
16. Previous urinary tract surgery or radiation therapy.
17. History of malignancy, per excluding patients who have not had disease within the last 5 years, patients with completely cured basal cell carcinoma or completely cured carcinoma in situ.
18. Patients with HIV, syphilis, hepatitis B and C diseases, including a history.
19. Liver disease that the study doctor believes may affect course and outcomes clinical trial, history of hepatic failure.
20. Severe, decompensated or unstable somatic diseases (any diseases or conditions that threaten the patient's life or worsen the patient's prognosis, and also make it impossible to conduct clinical trial with this patient).
21. Use of analgesic drugs activity, including systemic NSAIDs, as well as antispasmodic drugs less than 24 hours before taking study drug/placebo.
22. No history of efficacy of furasidine and/or no data furasidin sensitivity based on a history of urine microbiology.
23. The need for the use of drugs from the list of prohibited therapy.
24. Use of systemic antibacterial drugs actions within 7 days prior to screening.
25. Administration of other medicinal products which, in the opinion of the study doctor, may affect progress and results clinical trial.
26. Participation in another clinical trial within 3 months prior to screening.
27. Pregnancy or breastfeeding.
28. Alcohol or drug dependence, history of mental illness.
29. Patient unwillingness or inability to comply with procedures protocol (in the opinion of the study physician).
30. Other conditions that prevent the patient from being included in the study.
18 Years
65 Years
FEMALE
No
Sponsors
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PHARMENTERPRISES LLC
INDUSTRY
Responsible Party
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Locations
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Unimed-S Cjsc
Moscow, , Russia
LLC "Research Center Eco-Safety"
Saint Petersburg, , Russia
St. Petersburg State Budgetary Healthcare Institution "City Polyclinic № 112"
Saint Petersburg, , Russia
LLC "Research Center Eco-Safety"
Saint Petersburg, , Russia
LLC "Clinic Zvezdnaya"
Saint Petersburg, , Russia
North-West Center of Evidence-Based Medicine Jsc
Saint Petersburg, , Russia
Prime Rose Medical Center LLC
Saint Petersburg, , Russia
St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 4"
Saint Petersburg, , Russia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PAIN-XC243-02-01-2023
Identifier Type: -
Identifier Source: org_study_id
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