Study to Evaluate the Efficacy and Safety of XC243 in Patients With Exacerbation of Chronic Cystitis

Launched by PHARMENTERPRISES LLC · Apr 25, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called XC243 for women who have worsening symptoms of chronic cystitis, a condition that causes pain and discomfort when urinating. The study will include women aged 18 to 65 who have had multiple episodes of chronic cystitis and are currently experiencing symptoms like pain in the lower abdomen and burning during urination. Participants will be randomly assigned to receive either XC243 in different doses or a placebo (a dummy treatment) for 7 to 10 days. The goal is to see how quickly their symptoms improve.

To join the study, participants must not have taken certain medications recently and should not have other infections or serious health issues. They also need to agree to avoid alcohol during the trial. This is an important opportunity for women struggling with chronic cystitis to potentially find a new treatment option while contributing to medical research. If you or someone you know meets these criteria, this trial could be a way to help improve symptoms and find relief.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Availability of the Form signed and dated by the patient the Patient Information Leaflet informed consent (IMP).
• • 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:
• • 1. Hypersensitivity to the active and/or any of excipients of the test drug.
• • 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.