Radiation Cystitis Treated With Pentosan Polysulfate Sodium Trial
A Randomized, Controlled, Phase II/III Trial to Evaluate the Efficacy and Safety of U101 Oral Capsules in Radiation-induced Cystitis
National Taiwan University Hospital
72 participants
Apr 29, 2022
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to evaluate the efficacy and safety of pentosan polysulfate sodium versus placebo and in patients with radiation cystitis who have received radiation therapy in pelvic region.
Eligibility
Inclusion Criteria5
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in the study protocol.
- Patients must be ≥20 years of age
- Patients must have received definitive radiation therapy for cancer in pelvic area.
- Time from the end of radiation therapy to radiation cystitis must be longer than 6 months.
- Radiation cystitis with lower urinary tract symptoms or hematuria.
Exclusion Criteria14
- Abnormal liver function with indication of AST, ALT, or total bilirubin ≥ 1.5 times higher than normal
- Abnormal renal function with serum creatinine ≥ 1.5 times higher than normal
- Abnormal coagulation profile with PT/INR higher than normal
- Thrombocytopenia with platelet counts < 100,000/μL
- Pregnant or breastfeeding, expecting to pregnancy, or positive for pregnancy test
- Patients who have systemic inflammatory symptoms during screening period (ie, fever up to 38℃ or WBC counts >12,000/μL)
- Patients with known urinary tract infection within 6 months of randomization.
- Any previous intravesical instillation within 6 months of randomization (ie, hyaluronic acid instillation)
- Any previous hyperbaric oxygen therapy within 6 months of randomization
- Any previous treatment with pentosan polysulfate sodium within 6 months of randomization
- Has history of thrombocytopenia, hemophilia or bladder cancer
- Has known history of Human Immunodeficiency Virus (HIV) or organ transplantation
- Has known history of drug allergy to pentosan polysulfate sodium
- Has hematuria caused by clinically active urolithiasis or urothelial carcinoma
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Interventions
Pentosan Polysulfate Sodium 100 mg three times daily (tid) for 0-8 weeks Pentosan Polysulfate Sodium 100 mg twice daily (bid) for 9-16 weeks
Placebo 100 mg three times daily (tid) for 0-8 weeks Placebo 100 mg twice daily (bid) for 9-16 weeks
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05245591