Evaluate the Efficacy and Safety of U101 Oral Capsules in the Prevention of Uncomplicated rUTIs in Women
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age20-75
SponsorTCM Biotech International Corp.
About this trial
The goal of this clinical trial is to learn if drug U101 works to prevent recurrent urinary tract infection (rUTI) in women (≥ 20 and \< 76 years old) with a medical history. It will also investigate the safety and the impact on the Quality of Life improvement of drug U101. The main questions it aims to answer are:
* Does the drug prevent or decrease the recurrence of urinary tract infection (UTI) during the 24-week treatment? * Will the Quality of Life be improved during the 24-week treatment? * What medical problems do participants have when taking drug U101?
Researchers will compare drug U101 to a placebo (a look-alike substance that contains no drug) to see if drug U101 works to prevent rUTI.
Participants will:
* Orally take drug U101 or placebo every day for 24 weeks in the main study, three times per day (TID) for 8 weeks and twice per day (BID) for 16 weeks. * Visit the site once every 4 weeks for checkups and tests during the main study. * be asked to enroll in extensional study (the open-label extension (OLE) with drug U101 treatment or the Safety Follow-Up Visits with no investigational product treatment) for 24 weeks after they complete the 24-week main study. * Visit the site when the suspected UTI occurred during the main study or the extension study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provide a signed informed consent form.
Non-pregnant, non-nursing females ≥ 20 and < 76 years old.
Having a history of ≥ 2 UTI events during the preceding 6 months or ≥ 3 UTI events during the preceding 12 months (including any UTI event that occurs on the date of ICF signing). At least one of the previous UTI events must have microbiologic evidence (e.g., per the investigator's judgment based on urine culture results).
The last urine culture (including those conducted for suspected UTI event or retest) before the randomization has to be negative.
Disqualifiers
Females who are pregnant, nursing, have a desire for pregnancy or have a positive pregnancy test at screening.
Women of childbearing potential who are unwilling or unable to use an acceptable contraceptive method to avoid pregnancy for the entire study period (use of spermicide is prohibited). Women of childbearing potential are defined as premenopausal females capable of becoming pregnant.
Serum aspartate transaminase (AST), serum alanine transaminase (ALT) and serum total bilirubin > 1.5 x upper limit of normal (ULN).
Serum creatinine > 1.5 x ULN.
Trial design
Design model
Parallel
Treatments tested in this trial
U101
DrugOne capsule (100 mg) of U101 will be administered orally three times per day (TID) for 8 weeks followed by one capsule of U101 twice per day (BID) for 16 weeks.
Placebo
Other interventionOne capsule of Placebo will be administered orally three times per day (TID) for 8 weeks followed by one capsule of placebo twice per day (BID) for 16 weeks.
Treatment groups
348 Participants
are divided into 2 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: U101Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of subjects without UTI recurrence during the 24-week main study period
To demonstrate the efficacy of U101 in preventing recurrent urinary tract infections (rUTIs) in women
Time frame
The primary analysis will be performed at the end of the 24-week main studySecondary outcomes
1
Time to the first UTI episode during the main study period
To evaluate the specified time period of rUTI prevention after enrollment
Time frame
This analysis will be performed at the end of the 24-week main study2
Percentage of subjects with ≤ 1 UTI episode during the main study period
To evaluate the percentage of rUTI ≤ 1 episode after enrollment
Time frame
This analysis will be performed at the end of the 24-week main study3
Average number of time-normalized UTI episodes per 4 weeks during the main study period
To evaluate the decrease in UTI recurrence after enrollment
Time frame
This analysis will be performed at the end of the 24-week main study4
Quality of Life assessment: Daily Activities Interference during the main study period
Subject self-assessment questionnaire to evaluate the degree to which daily activities are affected. Measured on a 0-4 ordinal scale, with higher scores indicating greater interference.
Time frame
This analysis will be performed at the end of the 24-week main studySponsors and contacts
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Source ClinicalTrials.gov