Clinical Trials List
2020-05-18 - 2023-12-31
Phase III
Not yet recruiting7
Recruiting6
Terminated6
ICD-10N39.0
Urinary tract infection, site not specified
ICD-9599.0
Urinary tract infection, site not specified
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
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Trial Applicant
Efficient Pharma Management Corp.
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Sponsor
TCM Biotech International Corp.
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Trial scale
Taiwan Multiple Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Tzu-Ping Lin Division of Urology
- Chih-Chieh Lin Division of Urology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 馮國剛 Division of Urology
- PO-MING CHOW Division of Urology
- JIAN-HUA HONG Division of Urology
- 姜宜妮 Division of Urology
- YI-KAI CHANG Division of Urology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Hung-Lung Ke Division of Urology
- 黃俊農 Division of Urology
- 曾漢儀 Division of Ophthalmology
- Ching-Chia Li Division of Urology
- Sheng-Chen Wen Division of Urology
- Hao-Wei Chen Division of Urology
- Wen-Jeng Wu Division of Urology
- 李政學 Division of Urology
- 阮雍順 Division of Urology
- Tsung-Yi Huang Division of Urology
- Hsiang Ying Lee Division of Urology
- Cheng-Yu Long Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- FANG-YU KU Division of Urology
- 金宏諺 Division of Obstetrics & Gynecology
- JENG-CHENG WU Division of Urology
- SHIH-HSIU LO Division of Urology
- CHING-HSIN Chang Division of Urology
- WEI-CHIEH CHEN Division of Urology
- 蔡振行 Division of Ophthalmology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 高耀臨 Division of Urology
- Kuan-Yu Wu Division of Urology
- 翁涵育 Division of Urology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 黃靖崴 Division of Urology
- Yuan-Cheng Chu Division of Urology
- 蘇世桓 Division of Urology
- 許毓昭 Division of Urology
- 黃亮鋼 Division of Urology
- 潘柏諺 Division of Urology
- 張博誌 Division of Urology
- 陳怡杏 Division of Ophthalmology
- 李允仁 Division of Urology
- 楊佩珊 Division of Urology
- 曹書瀚 Division of Urology
- 蔡翰宇 Division of Urology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Po-Jen Hsiao Division of Urology
- 吳映萱 Division of Ophthalmology
- Yu-De Wang Division of Urology
- 龔偉勛 Division of Ophthalmology
- Yi-Huei Chang Division of Urology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
• Percentage of subjects without UTI recurrence during the 24-week main study period
Secondary Endpoints
1. Time to the first UTI episode during the main study period
2. Percentage of subjects with 1 UTI episode during the main study period
3. Average number of UTI episodes during the main study period
4. Quality of Life assessment: QoL and UTI questionnaires during the main study period
5. Treatment-emergent adverse events (TEAE), and all AE and serious adverse events
(SAE) during the main study period
6. Safety laboratory parameters (blood and urine) during the main study period
7. Physical examination and vital signs during the main study period
Inclution Criteria
1. Provide a signed informed consent form
2. Non-pregnant, non-nursing females between 20-70 years old (inclusive)
3. Having 2 episodes of UTI during the preceding 6 months or 3 episodes during the preceding 12 months (including the recent episode described in the Inclusion Criteria 4)
4. Having a recent episode of clinically and microbiologically documented uncomplicated acute UTI that has resolved as evidenced by a negative urine culture (no single species of bacteria 105 CFU/mL) at the screening visit
5. Having a negative urinalysis result and no symptoms suggestive of an UTI on the day of randomization
Exclusion Criteria
1. Females who are pregnant, nursing, have desire for pregnancy, or have a positive pregnancy test at screening
2. 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)
3. Serum aspartate transaminase (AST), serum alanine transaminase (ALT) and serum total bilirubin > 1.5 upper limit of normal (ULN)
4. Serum creatinine > 1.5 ULN
5. Prothrombin time (PT) and activated partial thromboplastin time (aPTT) > 1.0 ULN
6. Platelet counts < 100,000/L
7. Serum vitamin D level < 20 ng/mL
8. History of diabetes with associated peripheral vascular disease
9. Positive test for hepatitis B (HBsAg), hepatitis C (anti-HCV antibody) or HIV (anti-HIV antibody)
10. Symptoms suggestive of systemic inflammatory response (fever > 38℃ or WBC count > 12,000) at the screening visit
11. A major functional or anatomical abnormality of the urogenital tract (ex: renal cell carcinoma, outlet obstruction etc.)
12. Diagnosis of pelvic organ prolapse grade 2 (according to pelvic organ prolapse quantification POP-Q classification) without any treatment within 6 months of the screening visit
13. Diagnosis of complicated UTIs within 6 months of the screening visit
14. Residual urine volume > 100 mL within a month of the screening visit
15. History of interstitial cystitis, pelvic inflammatory disease, or chronic pelvic pain syndrome
16. Having any of the following procedures within a week of the screening: urinary catheterization (ex: Foley catheter), ureteral stent, percutaneous nephrostomy, or cystosomy
17. Intravesical instillation of hyaluronic acid within 6 months of the screening visit
18. Treatment with pentosan polysulfate sodium (PPS) within 6 months of the screening visit
19. Use of antibiotic prophylaxis for rUTI within a month of the screening visit
20. Use of local hormone therapy (cream, gel, insert, ring, or tablets) in urogenital areas within a month of the screening visit
21. Use of coumadin, anticoagulants, heparin, or thrombolytic agents such as tissue plasminogen activator (t-PA), streptokinase, or high dose aspirin ( 1 g/day) within a month of the screening visit
22. History of thrombocytopenia, hemophilia, or gastrointestinal ulcers
23. History of cancer, with the exception of adequately treated basal cell carcinoma
and cervical cancer in-situ, superficial bladder tumor (Ta: non-invasive tumor), or
Tis (in-situ) within 5 years prior to randomization
24. Immunocompromised or history of organ transplant
25. History of allergies to pentosan polysulfate sodium
26. Having planned major surgery within 24 weeks after the study
27. Participation in any interventional clinical trial within 30 days of the screening visit
28. Other significant medical problem(s) or intercurrent acute illness(es) that in the opinion of the Investigators, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with
achieving the study objective.
The Estimated Number of Participants
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Taiwan
348 participants
-
Global
0 participants
