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Идёт набор NCT05245591

Radiation Cystitis Treated With Pentosan Polysulfate Sodium Trial

Фаза II / Фаза III С лечением Radiation Cystitis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Pentosan Polysulfate Sodium 100 MG Oral Capsule, Placebo.
Кому может быть актуально
Состояния в реестре: Radiation Cystitis. Базовые параметры: от 20 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Тайвань
Следующий шаг
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Официальное название

A Randomized, Controlled, Phase II/III Trial to Evaluate the Efficacy and Safety of U101 Oral Capsules in Radiation-induced Cystitis

Обзор

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.

Подробное описание

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).

Вмешательства

  • Препарат 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
  • Препарат Placebo
    Placebo 100 mg three times daily (tid) for 0-8 weeks Placebo 100 mg twice daily (bid) for 9-16 weeks

Первичные конечные точки

  • Rate of complete remission in lower urinary tract symptoms and hematuria [Срок оценки: From date of randomization throughout the treatment period up to 5 years]
  • Time to complete remission [Срок оценки: From date of randomization to study completion up to 5 years]
  • Time to hematuria recurrence [Срок оценки: From date of randomization to study completion up to 5 years]
  • Assessment of quality of life [Срок оценки: From date of randomization to study completion up to 5 years]
  • Assessment of symptoms [Срок оценки: From date of randomization to study completion up to 5 years]
Вторичные конечные точки (3)
  • Duration of hospitalization [Срок оценки: From date of randomization to study completion up to 5 years]
  • Number of invasive procedures [Срок оценки: From date of randomization to study completion up to 5 years]
  • Number of adverse events [Срок оценки: From date of randomization to study completion up to 5 years]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Лечение

Центры проведения

Тайвань · 1 центр
  • National Taiwan University Hospital — Taipei

Идентификаторы

NCT: NCT05245591 · 202108161MIPD

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗