Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of XC243 in Patients With Exacerbation of Chronic Cystitis
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Cystitis
- Sponsor
- PHARMENTERPRISES LLC
- Enrollment
- 280
- Locations
- 7
- Primary Endpoint
- Time from the first dose of IP treatment until the symptom "Pain, discomfort or burning when urination " disappears (decreases).
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
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).
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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).
Arms & Interventions
Placebo
Intervention: Placebo
XC243 25 mg
XC243 25 mg single
Intervention: XC243 25 mg
XC243 50 mg
XC243 50 mg single
Intervention: XC243 50 mg
XC243 75 mg
XC243 75 mg single
Intervention: XC243 75 mg
Outcomes
Primary Outcomes
Time from the first dose of IP treatment until the symptom "Pain, discomfort or burning when urination " disappears (decreases).
Time Frame: Day 1 - Day 10
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.
Secondary Outcomes
- Severity of the symptom "Pain, discomfort or burning with urination "as per VAS(Day 1 - Day 11)
- Dynamics of the symptom "Pain or burning when urinating" according to VAS within first 24 hours post-dose(Day 1 - Day 2)
- Dynamics of the symptom "Pain, discomfort or burning when urinating" by VAS.(Day 1 - Day 11)
- Assesment by Global Clinical Impression Scale score (CGI-i)(Day 1 - Day 11)
- Frequency of patients with disappearance of the symptom "pain or urinary burning " by ACSS(Day 1 - Day 11)
- Assessment of disease symptoms by Acute Cystitis Symptom Score (ACSS).(Day 1 - Day 11)
- Dynamics of quality of life according to the ACSS scale(Day 1 - Day 11)
- Frequency of patients with disappearance of all typical symptoms diseases(Day 1 - Day 11)
- Frequency of patients with disappearance of the symptom "pain or discomfort in the lower abdomen (suprapubic region) " by ACSS(Day 1 - Day 11)
- Scale score by Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF Scale)(Day 1 - Day 11)
- Dynamics of symptoms of the disease according to the Diary patient.(Day 1 - Day 11)
- Mean urinary frequency per day by Patient Diary(Day 1 - Day 11)
- Dynamics of typical symptoms according to the ACSS scale(Day 1 - Day 11)
- Time to disappearance of typical disease symptoms for each symptom by ACSS(Day 1 - Day 11)
- Evaluation of the efficacy of therapy by 5 rating scale(Day 1 - Day 11)