[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100458128":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":39,"locations":45,"responsibleParty":60,"collaborators":62,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":34,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":34,"enrollmentInfo":75,"targetDuration":34,"studyType":78,"phases":79,"briefSummary":82,"conditions":83,"keywords":34,"overallStatus":47,"whyStopped":34,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"National Taiwan University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Pentosan Polysulfate Sodium","EXPERIMENTAL","U101 is available as a capsule containing 100 milligrams (mg) of pentosan polysulfate sodium. Subjects will be administered U101 at a dose of 300 milligrams (mg) three times daily (tid) for the initial 8 weeks and then 200 milligrams (mg) twice daily (bid) for another 8 weeks during the study.",[13],"Drug: Pentosan Polysulfate Sodium 100 MG Oral Capsule",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Control","PLACEBO_COMPARATOR","Placebo to match U101 is available as a capsule in 100 milligrams (mg). Subjects will be administered placebo at a dose of 300 milligrams (mg) three times daily (tid) for the initial 8 weeks and then 200 milligrams (mg) twice daily (bid) for another 8 weeks during the study.",[19],"Drug: Placebo",[21,30],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Pentosan Polysulfate Sodium 100 MG Oral Capsule","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",[9],[27,28,29],"Urosan","ELMIRON","PPS",{"type":22,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Placebo","Placebo 100 mg three times daily (tid) for 0-8 weeks Placebo 100 mg twice daily (bid) for 9-16 weeks",[15],null,[36],{"name":37,"affiliation":5,"role":38},"Chao-Yuan Huang, MD, PhD","PRINCIPAL_INVESTIGATOR",[40],{"name":41,"role":42,"phone":43,"phoneExt":34,"email":44},"Chi-Shin Tseng, MD","CONTACT","+886223123456","clifford1987tcs@gmail.com",[46],{"facility":5,"status":47,"city":48,"state":34,"zip":34,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","Taipei","Taiwan","TW",{"type":52,"coordinates":53},"Point",[54,55],121.52639,25.05306,{"lat":55,"lon":54},[58],{"name":59,"role":42,"phone":34,"phoneExt":34,"email":34},"Chao-Yuan Huang, phD",{"type":61,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR",[63],{"name":64,"class":65},"TCM Biotech International Corporation","UNKNOWN","100458128","phase-2-radiation-cystitis-treated-with-pentosan-polysulfate-sodium-trial-100458128",false,"NCT05245591","Radiation Cystitis Treated With Pentosan Polysulfate Sodium Trial","A Randomized, Controlled, Phase II\u002FIII Trial to Evaluate the Efficacy and Safety of U101 Oral Capsules in Radiation-induced Cystitis","Inclusion Criteria:\n\n1. 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.\n2. Patients must be ≥20 years of age\n3. Patients must have received definitive radiation therapy for cancer in pelvic area.\n4. Time from the end of radiation therapy to radiation cystitis must be longer than 6 months.\n5. Radiation cystitis with lower urinary tract symptoms or hematuria.\n\nExclusion Criteria:\n\n1. Abnormal liver function with indication of AST, ALT, or total bilirubin ≥ 1.5 times higher than normal\n2. Abnormal renal function with serum creatinine ≥ 1.5 times higher than normal\n3. Abnormal coagulation profile with PT\u002FINR higher than normal\n4. Thrombocytopenia with platelet counts \\\u003C 100,000\u002FμL\n5. Pregnant or breastfeeding, expecting to pregnancy, or positive for pregnancy test\n6. Patients who have systemic inflammatory symptoms during screening period (ie, fever up to 38℃ or WBC counts \\>12,000\u002FμL)\n7. Patients with known urinary tract infection within 6 months of randomization.\n8. Any previous intravesical instillation within 6 months of randomization (ie, hyaluronic acid instillation)\n9. Any previous hyperbaric oxygen therapy within 6 months of randomization\n10. Any previous treatment with pentosan polysulfate sodium within 6 months of randomization\n11. Has history of thrombocytopenia, hemophilia or bladder cancer\n12. Has known history of Human Immunodeficiency Virus (HIV) or organ transplantation\n13. Has known history of drug allergy to pentosan polysulfate sodium\n14. Has hematuria caused by clinically active urolithiasis or urothelial carcinoma","ALL","20 Years",{"count":76,"type":77},72,"ESTIMATED","INTERVENTIONAL",[80,81],"PHASE2","PHASE3","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.",[84],"Radiation Cystitis","2022-05-02",{"date":87,"type":88},"2022-05-04","ACTUAL",{"date":90,"type":88},"2022-04-29",{"date":92,"type":77},"2029-11-01",{"name":5,"class":6},1]