NCT00527917已完成2 期
A Multi-Center, Randomized, Double-Blind, Parallel Group Evaluation of the Efficacy and Safety of Uracyst® (Intravesical Sodium Chondroitin Sulfate) Versus Vehicle Placebo in Patients With Interstitial Cystitis/Painful Bladder Syndrome.
Watson Pharmaceuticals13 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2007年9月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 13
- 主要终点
- Change from baseline to 6 weeks in Global Response Assessment instrument (GRA)score. The GRA evaluates symptoms of intersticial cystitis
研究概览
简要总结
This is a pilot clinical investigation. Patients who meet the eligibility criteria and provide signed informed consent will be randomized to receive either an active product (Uracyst®) or placebo intravesically via a bladder catheter weekly for 6 weeks, followed by 6 weeks of follow-up period.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Are female of male patient 18 years or older
- •Have been previously diagnosed with IC/PBS.
- •Are willing to provide informed consent
- •Available for the duration of the study including treatment and follow-up (12 weeks)
排除标准
- •Pregnant or lactating female.
- •Are currently or have previously received investigational drugs within thirty (30) days of screening.
- •Previous therapy for IC/PBS
- •Have any medical condition/disease that could interfere with patient compliance or interfere with interpretation of the study results.
- •Are unable or unwilling to comply with protocol requirements
- •Are unable to read, understand, and provide written informed consent.
结局指标
主要结局
Change from baseline to 6 weeks in Global Response Assessment instrument (GRA)score. The GRA evaluates symptoms of intersticial cystitis
时间窗: Baseline to 6 weeks
次要结局
- Adverse event assessments(Throughout the study, first instillation to Week 12)
研究者
研究点 (13)
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