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

NCT06391164 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: PAIN-XC243-02-01-2023
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 8

Brief 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

Keywords

Phase II; VAS

Outcome Measures

Primary Outcomes (1)

• Time from the first dose of IP treatment until the symptom "Pain, discomfort or burning when urination " disappears (decreases).

  Symptom disappears (decreases) criterion "Pain, discomfort or burning during urination "is considered to be the simultaneous fulfillment of the following conditions: Improvement to 1 point or less in VAS and Maintain VAS score of 1 point or less for 24 hours. Within 96 hours (4 days) after the first dose of the IP assessment of the symptom "Pain, discomfort or burning when urinating" will be conducted by the patient after each urination. After 96 hours (from day 5) evaluation this symptom will be carried out 2 times a day (8-00 to 10-00 hours and from 20-00 to 22-00 hours over time). Superiority over placebo will be considered established if difference in mean between groups (XC243 - placebo) by symptom reduction time would be greater than 11 hours at the time of treatment evaluation.

  Day 1 - Day 10

Secondary Outcomes (15)

• Severity of the symptom "Pain, discomfort or burning with urination "as per VAS

  Day 1 - Day 11

• Dynamics of the symptom "Pain, discomfort or burning when urinating" by VAS.

  Day 1 - Day 11

• Assessment of disease symptoms by Acute Cystitis Symptom Score (ACSS).

  Day 1 - Day 11

• Dynamics of typical symptoms according to the ACSS scale

  Day 1 - Day 11

• Dynamics of quality of life according to the ACSS scale

  Day 1 - Day 11

Study Arms (4)

XC243 25 mg

EXPERIMENTAL

XC243 25 mg single

Drug: XC243 25 mg

XC243 50 mg

EXPERIMENTAL

XC243 50 mg single

Drug: XC243 50 mg

XC243 75 mg

EXPERIMENTAL

XC243 75 mg single

Drug: XC243 75 mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

XC243 25 mg DRUG

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

XC243 25 mg

XC243 50 mg DRUG

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

XC243 50 mg

XC243 75 mg DRUG

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

XC243 75 mg

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Availability of the Form signed and dated by the patient the Patient Information Leaflet informed consent (IMP).
• Women aged 18 to 65 years inclusive at the time of signing the Informed IMP consent.
• 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).
• 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).
• The appearance of symptoms of exacerbation of chronic cystitis is not \> 48 hours prior to screening visit.
• Severity of the symptom "Pain, discomfort or burning with urination "from 4 to 8 VAS points.
• No therapy for current cystitis exacerbation (including phosphomycin and/or furasidin for the treatment of current exacerbation).
• The patient's consent to refrain from drinking alcoholic beverages during the period of participation in study.
• Patient consent to use reliable methods contraception throughout the study and through 3 weeks after its end.

You may not qualify if:

• Hypersensitivity to the active and/or any of excipients of the test drug.
• Hypersensitivity to furasidine and/or any of the excipients concomitant medication.
• Chronic recurrent cystitis due to infections, sexually transmitted diseases (STIs): gonorrhea, chlamydia, ureaplasmosis, mycoplasmosis, herpes, candidiasis, gardnerellosis, history of trichomoniasis.
• Chronic recurrent cystitis of viral etiology (caused by adenovirus, cytomegalovirus, virus human papillomavirus herpes).
• Axillary body temperature ≥ 38 ° C at the screening visit.
• Presence of menstruation at randomization or estimated onset of menstruation during the period therapy.
• Pain in the lumbar region.
• Itching and abundant vaginal discharge and/or purulent discharge from the genitourinary tract.
• History and/or findings of genitourinary anatomical disorders ultrasound examination (hydronephrosis, sclerosis of the bladder neck, cystocele, descent uterus, paraurethral cyst).
• Presence of inflammatory diseases of the sexual system (vaginitis, colpitis, cervicitis).
• 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.
• Chronic renal failure.
• Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus.
• History of pseudomembranous colitis.
• Signs of macrohematuria (admixture of blood in the urine, discoloration of the urine).

Sponsors & Collaborators

• PHARMENTERPRISES LLC: lead

Study Sites (8)

Unimed-S Cjsc

Moscow, 119571, Russia

Location

LLC "Research Center Eco-Safety"

Saint Petersburg, 191119, Russia

Location

St. Petersburg State Budgetary Healthcare Institution "City Polyclinic № 112"

Saint Petersburg, 195427, Russia

Location

LLC "Research Center Eco-Safety"

Saint Petersburg, 196143, Russia

Location

LLC "Clinic Zvezdnaya"

Saint Petersburg, 196158, Russia

Location

North-West Center of Evidence-Based Medicine Jsc

Saint Petersburg, 196158, Russia

Location

Prime Rose Medical Center LLC

Saint Petersburg, 197374, Russia

Location

St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 4"

Saint Petersburg, 199178, Russia

Location

MeSH Terms

Conditions

Cystitis

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Vladimir Nebolsin

CONTACT

+79175584626; nve1970@mail.ru

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Blinding was carried out by using placebo equivalent to XC243 tablets without active pharmaceutical ingredients (API) and the corresponding labeling of the ID.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel proup

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: April 30, 2024
• Study Start: April 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (8)