NCT06391164

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

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: PHARMENTERPRISES LLC · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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.

Conditions

• Cystitis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2024-04-30
• Last updated: 2024-04-30

Locations

8 sites across 1 country: Russia