A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating Safety and Efficacy of LiRIS® 400 mg in Females With Interstitial Cystitis/Bladder Pain Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 131
- 试验地点
- 34
- 主要终点
- Change From Baseline in Daily Average Bladder Pain to Treatment 1 Week 4 Follow-up
研究概览
简要总结
This is a safety and efficacy study of LiRIS® in females with interstitial cystitis/bladder pain syndrome.
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
- Double (Participant, Investigator)
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
- •Diagnosis of interstitial cystitis or bladder pain syndrome
排除标准
- •Diagnosis of interstitial cystitis with Hunner's lesions/ulcers
- •Previous treatment with LiRIS®
研究组 & 干预措施
LiRIS® (Treatment Period 1)/LiRIS® (Treatment Period 2)
Treatment Period 1: continuous release of lidocaine inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1. Treatment Period 2: optional continuous release of lidocaine inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2.
干预措施: LiRIS® (Combination Product)
LiRIS Placebo (Treatment Period 1)/LiRIS® (Treatment Period 2)
Treatment period 1: Matching placebo device to LiRIS inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1. Treatment Period 2: optional continuous release of lidocaine inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2.
干预措施: LiRIS® (Combination Product)
LiRIS Placebo (Treatment Period 1)/LiRIS® (Treatment Period 2)
Treatment period 1: Matching placebo device to LiRIS inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1. Treatment Period 2: optional continuous release of lidocaine inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2.
干预措施: LiRIS Placebo (Combination Product)
结局指标
主要结局
Change From Baseline in Daily Average Bladder Pain to Treatment 1 Week 4 Follow-up
时间窗: Baseline (Days -7 to 0) to Treatment 1 Week 4
The participant recorded their bladder pain over the previous 24-hour period in a 7-day pain assessment tool using an 11-point Numeric Rating Scale (NRS) (0 to 10) where 0=no pain to 10= worst pain. Pain data recorded over the 7-day period were averaged. A negative change from Baseline indicates improvement. An Analysis of Covariance (ANCOVA) model with baseline value as a covariate and treatment group and stratification factors (age group: \< 40 years or ≥ 40 years and baseline bladder pain NRS: ≤ 6 or \> 6) as factors was used for analysis.
次要结局
未报告次要终点