Radiation Cystitis Treated With Pentosan Polysulfate Sodium Trial
ConditionRadiation Cystitis
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age20+
SponsorNational Taiwan University Hospital
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Pentosan Polysulfate Sodium 100 MG Oral Capsule
- Placebo
Treatment groups
72 Participants
are divided into 2 treatment groupsSponsors and collaborators
National Taiwan University Hospital
Lead sponsor
TCM Biotech International Corporation
Collaborator
Source ClinicalTrials.gov