Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06391164
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-04-25
Brief Title:
Study to Evaluate the Efficacy and Safety of XC243 in Patients With Exacerbation of Chronic Cystitis
Sponsor:
PHARMENTERPRISES LLC
Organization:
PHARMENTERPRISES LLC
Study Overview
Official Title:
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
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 1111 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
Upon completion of screening patients will be randomized to 4 groups in the ratio 1111 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None