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

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 20
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

• Having a negative urinalysis result and no symptoms suggestive of a UTI on the day of randomization.

Locations
Other Locations
Taiwan
Chang Gung Memorial Hospital, Kaohsiung Branch
RECRUITING
Kaohsiung City
Kaohsiung Medical University Chung-Ho Memorial Hospital
ACTIVE_NOT_RECRUITING
Kaohsiung City
Taipei Tzu Chi Hospital
RECRUITING
New Taipei City
China Medical University Hospital
RECRUITING
Taichung
Chung Shan Medical University Hospital
RECRUITING
Taichung
Taichung Veterans General Hospital
RECRUITING
Taichung
National Cheng Kung University Hospital
RECRUITING
Tainan City
Chang Gung Memorial Hospital, Taipei Branch
RECRUITING
Taipei
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Medical University Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
Tri-Service General Hospital (TSGH)
RECRUITING
Taipei
Chang Gung Memorial Hospital, Linkuo Branch
RECRUITING
Taoyuan District
Contact Information
Primary
Emily Ma Clinical Research Manager
emilyma@tcmbio.com
+886-2-2697-2628
Backup
Principal Investigator
Time Frame
Start Date: 2020-10-14
Estimated Completion Date: 2028-07-31
Participants
Target number of participants: 348
Treatments
Placebo_comparator: Placebo
One 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.
Experimental: U101
One 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.
Related Therapeutic Areas
Sponsors
Leads: TCM Biotech International Corp.

This content was sourced from clinicaltrials.gov