Status:
RECRUITING
Radiation Cystitis Treated With Pentosan Polysulfate Sodium Trial
Lead Sponsor:
National Taiwan University Hospital
Collaborating Sponsors:
TCM Biotech International Corporation
Conditions:
Radiation Cystitis
Eligibility:
All Genders
20+ years
Phase:
PHASE2
PHASE3
Brief 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 reg...
Detailed Description
RCT-PPS is a phase II/III study evaluating the efficacy, safety, and tolerability of pentosan polysulfate sodium (PPS) versus placebo to patients with radiation cystitis who have received radiation th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2029
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT05245591
Start Date
April 29 2022
End Date
November 1 2029
Last Update
May 4 2022
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan