A Phase 2 interventional study of XC243 25 mg and XC243 50 mg in Cystitis, sponsored by PHARMENTERPRISES LLC. Not yet recruiting at 8 sites in Russian Federation. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-04-30.
Sponsored by PHARMENTERPRISES LLC · Phase 2, Interventional, and Treatment
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).
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.
69 studies on the registry are indexed under Cystitis; 17 are open to participants now.
This study's planned enrollment of 280 is above the median of 112 across 50 interventional studies indexed under Cystitis.
Browse Cystitis studies →PHARMENTERPRISES LLC is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
XC243 25 mg single
Drug: XC243 25 mg
XC243 50 mg single
Drug: XC243 50 mg
XC243 75 mg single
Drug: XC243 75 mg
Drug: Placebo
Patients will receive the Investigated Product (IP) once in the morning at least 30 minutes before eating for 7-10 days
Patients will receive the IP once in the morning at least 30 minutes before eating for 7-10 days
Patients will receive the IP once in the morning at least 30 minutes before eating for 7-10 days
Patients will receive the IP once in the morning at least 30 minutes before eating for 7-10 days
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.
Time frame: Day 1 - Day 10
Severity of the symptom "Pain, discomfort or burning with urination "as per VAS
Severity of the symptom "Pain, discomfort or burning with urination "as per VAS to Visit 2 (Day 2), Visit 3 (Day 5), Visit 4 (Day 8), End of therapy Visit (Day 11)
Time frame: Day 1 - Day 11
Dynamics of the symptom "Pain, discomfort or burning when urinating" by VAS.
Dynamics of the symptom "Pain, discomfort or burning when urinating" by VAS to End of therapy Visit
Time frame: Day 1 - Day 11
Assessment of disease symptoms by Acute Cystitis Symptom Score (ACSS).
ACSS assessment of disease symptoms to Visit 2 (Day 2), Visit 3 (Day 5), Visit 4 (Day 8), End of therapy Visit (Day 11)
Time frame: Day 1 - Day 11
Dynamics of typical symptoms according to the ACSS scale
Dynamics of typical symptoms of the disease according to the ACSS scale to Visit 2 (Day 2), Visit 3 (Day 5), Visit 4 (Day 8), End of therapy Visit (Day 11)
Time frame: Day 1 - Day 11
Dynamics of quality of life according to the ACSS scale
Dynamics of quality of life according to the ACSS scale to Visit 2 (Day 2), Visit 3 (Day 5), Visit 4 (Day 8), End of therapy Visit (Day 11)
Time frame: Day 1 - Day 11
Frequency of patients with disappearance of all typical symptoms diseases
Frequency of patients with disappearance of all typical symptoms diseases (ACSS score 0) to Visit 2 (Day 2), Visit 3 (Day 5), Visit 4 (Day 8), End of therapy Visit (Day 11)
Time frame: Day 1 - Day 11
Time to disappearance of typical disease symptoms for each symptom by ACSS
Time to disappearance of typical disease symptoms (score 0 on the ACSS scale) for each symptom to Visit 2 (Day 2), Visit 3 (Day 5), Visit 4 (Day 8), End of therapy Visit (Day 11)
Time frame: Day 1 - Day 11
Frequency of patients with disappearance of the symptom "pain or urinary burning " by ACSS
Frequency of patients with disappearance of the symptom "pain or urinary burning "(ACSS score 0) to Visit 2 (Day 2), Visit 3 (Day 5), Visit 4 (Day 8), End of therapy Visit (Day 11)
Time frame: Day 1 - Day 11
Frequency of patients with disappearance of the symptom "pain or discomfort in the lower abdomen (suprapubic region) " by ACSS
Frequency of patients with disappearance of the symptom "pain or discomfort in the lower abdomen (suprapubic region) "(score 0 according to ACSS) to Visit 2 (Day 2), Visit 3 (Day 5), Visit 4 (Day 8), End of therapy Visit (Day 11)
Time frame: Day 1 - Day 11
Scale score by Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF Scale)
Scale score by PUF Scale to Visit 2 (Day 2), Visit 3 (Day 5), Visit 4 (Day 8), End of therapy Visit (Day 11)
Time frame: Day 1 - Day 11
Dynamics of symptoms of the disease according to the Diary patient.
Dynamics of symptoms of the disease according to the Diary patient to Visit 2 (Day 2), Visit 3 (Day 5), Visit 4 (Day 8), End of therapy Visit (Day 11)
Time frame: Day 1 - Day 11
Dynamics of the symptom "Pain or burning when urinating" according to VAS within first 24 hours post-dose
Dynamics of the symptom "Pain or burning when urinating" according to VAS within first 24 hours post-dose
Time frame: Day 1 - Day 2
Mean urinary frequency per day by Patient Diary
Mean urinary frequency per day by Patient Diary to Visit 2 (Day 2), Visit 3 (Day 5), Visit 4 (Day 8), End of therapy Visit (Day 11)
Time frame: Day 1 - Day 11
Assesment by Global Clinical Impression Scale score (CGI-i)
Patient's CGI-i score
Time frame: Day 1 - Day 11
Evaluation of the efficacy of therapy by 5 rating scale
Evaluation of the efficacy of therapy by 5 rating scale to Visit 2 (Day 2), Visit 3 (Day 5), Visit 4 (Day 8), End of therapy Visit (Day 11). This scale is assessed by the investigator, where 1 point - absence, 2 points - regression, 3 points - decrease in severity, 4 points - lack of positive dynamics, 5 points - increase in the main clinical symptoms
Time frame: Day 1 - Day 11
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Apr 2024; primary completion for Dec 2025, 20 months later.
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This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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PHARMENTERPRISES LLC