Evaluate the Efficacy and Safety of U101 Oral Capsules in the Prevention of Uncomplicated rUTIs in Women
brief summary
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.
detailed description
This is a randomized, double-blind, placebo-controlled, Phase 3 study evaluating the efficacy and safety of U101 versus placebo in women with recurrent urinary tract infections (UTIs).
The study will be conducted primarily on an outpatient basis and consist of (1) a Screening Period, (2) a Main Study (24 weeks), and (3) an optional Open-Label Extension (OLE) program/Follow-Up Period (total 24 weeks). The study plans to enroll a total of 348 participants.
Female participants (≥ 20 and \< 76 years old) who have experienced rUTIs (defined as ≥ 2 UTI events in a 6-month period or ≥ 3 UTI events in a 12-month period) but confirmed resolved infection before randomization will be the potential candidates to enroll in this study.
During the screening period, patients with a history of rUTIs who present at the study sites will be identified. The potential participants will proceed with other study-specific activities to confirm their eligibility. Once confirmed, participants will be stratified based on their menopausal status (Yes/No) and study site then randomized into the main study in a 1:1 ratio to receive U101 or matching placebo.
During the main study, one capsule (100 mg) of U101 or matching placebo will be administered orally three times per day (TID) for 8 weeks followed by one capsule of U101 or matching placebo twice per day (BID) for 16 weeks. The total study duration will be 24 weeks and participants will be required to attend site visits every 4 weeks (routine visits).
If participants develop symptoms or have a positive urinalysis result suggestive of a UTI at any time after receiving the first dose of study medication during the main study and the OLE/Follow-up period, they are instructed to contact the study staff to arrange for a special visit for examination (suspected UTI visit). If the investigator suspects a UTI recurrence and prescribes systematic antibiotics as a result, the study medication will be interrupted. After the resolution of the infection, the study medication will be reintroduced again on a TID dosing schedule.
Participants will be offered to enroll in the open-label extension (OLE) program or enter the Follow-Up Visits after they complete the 24-week main study.
The purpose of the OLE is to collect additional safety and efficacy data. Eligible participants and the investigators will decide whether the participants should receive U101 treatment (TID for 8 weeks followed by BID for 16 weeks) or enter the long-term follow-up period without any treatment. To receive U101 treatment during the OLE, participants must experience at least 1 UTI episode during the 24-week main study. The OLE will last for 24 weeks and all participants will be scheduled for two visits at Week 8 and Week 24. The OLE may be terminated contingent on the primary analysis results of the main study.
official title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of U101 Oral Capsules in the Prevention of Uncomplicated Recurrent Urinary Tract Infections (rUTIs) in Women