A Randomized, Controlled, Phase II/III Trial to Evaluate the Efficacy and Safety of U101 Oral Capsules in Radiation-induced Cystitis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Assessment of quality of life
研究概览
简要总结
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.
详细描述
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 therapy in pelvic region.
Approximately 72 patients were planned to be randomized in RCT-PPS trial in a 1:1 ratio to treatment with either PPS or placebo. Patients will receive oral treatment with 16 weeks (PPS 100mg three times a day for 8 weeks and then with PPS 100mg twice daily for another 8 weeks).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Pentosan Polysulfate Sodium
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.
干预措施: Pentosan Polysulfate Sodium 100 MG Oral Capsule (Drug)
Placebo Control
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.
干预措施: Placebo (Drug)
结局指标
主要结局
Assessment of quality of life
时间窗: From date of randomization to study completion up to 5 years
Functional Assessment of 36-Item Short Form Survey (SF-36)
Time to hematuria recurrence
时间窗: From date of randomization to study completion up to 5 years
Time from randomization to recurrence of hematuria
Rate of complete remission in lower urinary tract symptoms and hematuria
时间窗: From date of randomization throughout the treatment period up to 5 years
Number of participants without lower urinary tract symptoms and hematuria assessed by ESOU 2019 and CTCAE v5.0
Time to complete remission
时间窗: From date of randomization to study completion up to 5 years
Time from randomization to complete remission of lower urinary tract syndromes and hematuria
Assessment of symptoms
时间窗: From date of randomization to study completion up to 5 years
Functional Assessment of Expanded Prostate Cancer Index Composite-26 (EPIC-26)
次要结局
- Duration of hospitalization(From date of randomization to study completion up to 5 years)
- Number of invasive procedures(From date of randomization to study completion up to 5 years)
- Number of adverse events(From date of randomization to study completion up to 5 years)