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

NCT06391164 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2024-04-30

No results posted yet for this study

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).

Conditions

  • Cystitis

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

Sponsors & Collaborators

  • PHARMENTERPRISES LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-30
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Russia

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06391164 on ClinicalTrials.gov