A Multi-Center, Randomized, Double-Blind, Parallel Group Evaluation of the Effectiveness and Safety of Uracyst® Compared to Inactive Control in Subjects With Interstitial Cystitis/Painful Bladder Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 主要终点
- Global Response Assessment (GRA) Responders at Week 11.
研究概览
简要总结
A new device for interstitial cystitis is compared to inactive control to determine if it is safe and effective. The study lasts approximately 7 weeks with a 19-week follow-up period.
详细描述
Multi-center, randomized, double-blind, parallel, 8 weekly instillations over a 7-week period with post-treatment follow-up for an additional 19 weeks for a total study length of 26 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Are a female, 18 years or older
- •Have been diagnosed with IC/PBS
- •Are willing to provide written informed consent and authorization to disclose after being fully informed of the risks of participation
排除标准
- •Are lactating females
- •Have previously received investigational products or devices within 30 days of screening
- •Have previously received Uracyst
- •Are currently receiving therapy with Interstim®
- •Have any other condition/disease which, in the opinion of the investigator, could compromise subject safety or confound the interpretation of study results
- •Are unable or unwilling to comply with protocol requirements
研究组 & 干预措施
8 weekly bladder instillations of Uracyst
20 mL Uracyst (2% sodium chondroitin sulfate) per instillation; 8 instillations over a 7-week period
干预措施: 2% sodium chondroitin sulfate (Drug)
8 weekly bladder instillations of inactive control
20 mL inactive control buffer (phosphate-buffered saline); 8 instillations over a 7-week period
干预措施: Placebo (Drug)
结局指标
主要结局
Global Response Assessment (GRA) Responders at Week 11.
时间窗: at week 11
subjects that indicated "markedly improved" or "moderately improved" on the GRA, LOCF
次要结局
- Interstitial Cystitis Symptom Index (ICSI) Responders at Week 11.(at week 11)