Actively Recruiting
A Randomized, Controlled, Phase II/III Trial to Evaluate the Efficacy and Safety of U101 Oral Capsules for Radiation-induced Cystitis
Led by National Taiwan University Hospital · Updated on 2022-05-04
72
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
N
National Taiwan University Hospital
Lead Sponsor
T
TCM Biotech International Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying radiation cystitis in patients who have received radiation therapy in the pelvic area. This trial evaluates the safety and effectiveness of pentosan polysulfate sodium (PPS) compared to a placebo. The study is a phase II/III randomized controlled trial aiming to provide clearer evidence on treatment options for this condition. Participants are randomly assigned to receive either PPS or a matching placebo. The medication is taken orally for 16 weeks, starting with 300 mg three times daily for the first 8 weeks, followed by 200 mg twice daily for the next 8 weeks. Both groups follow the same dosing schedule to compare the effects accurately. During the study, participants will undergo regular assessments to monitor symptoms, quality of life, and the presence of hematuria (blood in urine). The main outcomes measured include the rate and timing of symptom remission and hematuria recurrence, monitored over up to 5 years. Safety is also tracked by recording adverse events, hospitalizations, and invasive procedures throughout the study period.
CONDITIONS
Brief Title
Radiation Cystitis Treated With Pentosan Polysulfate Sodium Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide signed informed consent and follow study requirements
- Age 20 years or older
- Received definitive radiation therapy for cancer in the pelvic area
- More than 6 months have passed since radiation therapy ended
- Have radiation cystitis with lower urinary tract symptoms or blood in urine
You will not qualify if you...
- Liver function tests with AST, ALT, or total bilirubin 1.5 times above normal
- Kidney function with serum creatinine 1.5 times above normal
- Abnormal blood clotting profile with high PT/INR
- Low platelet counts less than 100,000/μL
- Pregnant, breastfeeding, planning pregnancy, or positive pregnancy test
- Systemic inflammatory symptoms during screening (fever or high white blood cell count)
- Urinary tract infection within 6 months before randomization
- Intravesical instillation therapy within 6 months before randomization
- Hyperbaric oxygen therapy within 6 months before randomization
- Pentosan polysulfate sodium treatment within 6 months before randomization
- History of thrombocytopenia, hemophilia, or bladder cancer
- Known HIV infection or organ transplantation
- Known allergy to pentosan polysulfate sodium
- Blood in urine caused by active urolithiasis or urothelial carcinoma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 weeks
Participants receive oral capsules of pentosan polysulfate sodium or placebo for radiation cystitis.
Regular visits during treatment period (exact number not specified)
Duration - Up to 5 years
Participants are monitored for up to 5 years after treatment to assess remission, symptoms, quality of life, and any adverse events.
Visit schedule not specified
Trial Site Locations
Total: 1 location
1
National Taiwan University Hospital
Taipei, Taiwan
Actively Recruiting
Research Team
C
Chi-Shin Tseng, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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