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NOT YET RECRUITING
NCT06391164
PHASE2

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

Sponsor: PHARMENTERPRISES LLC

View on ClinicalTrials.gov

Summary

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).

Official title: Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of XC243 in Patients With Exacerbation of Chronic Cystitis

Key Details

Gender

FEMALE

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

280

Start Date

2024-04

Completion Date

2025-12

Last Updated

2024-04-30

Healthy Volunteers

No

Conditions

Interventions

DRUG

XC243 25 mg

Patients will receive the Investigated Product (IP) once in the morning at least 30 minutes before eating for 7-10 days

DRUG

XC243 50 mg

Patients will receive the IP once in the morning at least 30 minutes before eating for 7-10 days

DRUG

XC243 75 mg

Patients will receive the IP once in the morning at least 30 minutes before eating for 7-10 days

DRUG

Placebo

Patients will receive the IP once in the morning at least 30 minutes before eating for 7-10 days

Locations (8)

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