A Multicenter, Randomized, Double-blind, Placebo-controlled Study, Evaluating Safety and Efficacy of LiRIS® 400 mg in Females With Interstitial Cystitis With Hunner's Lesions
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 59
- 试验地点
- 19
- 主要终点
- Change From Baseline in the Daily Average Bladder Pain Numeric Rating Scale (NRS)
研究概览
简要总结
This is a safety and efficacy study of LiRIS® in females with interstitial cystitis with Hunner's lesions.
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 with Hunner's lesions/ulcers
排除标准
- •Previous treatment with LiRIS®
- •Interstitial cystitis/bladder pain syndrome, without Hunner's lesions/ulcers
研究组 & 干预措施
LiRIS Placebo, LiRIS Placebo (Tx 1)/LiRIS® (Tx 2)
Treatment 1 Period (Tx 1): Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 10 and then removed and a second matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 14 and removed on Day 28. Treatment 2 Period (Tx 2): optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14.
干预措施: LiRIS® (Drug)
LiRIS®, LiRIS® (Tx 1)/LiRIS® (Tx 2)
Treatment 1 Period: LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 then removed and a second LiRIS® 400 mg inserted into the bladder on Day 14 and removed on Day 28. Treatment 2 Period: optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and then removed on Day 14.
干预措施: LiRIS® (Drug)
LiRIS®, LiRIS® (Tx 1)/LiRIS® (Tx 2)
Treatment 1 Period: LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 then removed and a second LiRIS® 400 mg inserted into the bladder on Day 14 and removed on Day 28. Treatment 2 Period: optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and then removed on Day 14.
干预措施: LiRIS Placebo (Drug)
LiRIS Placebo, LiRIS® (Tx 1)/ LiRIS® (Tx 2)
Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 0 and then removed and LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 14 then removed on Day 28. Treatment 2 Period: optional LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 then removed on Day 14.
干预措施: LiRIS® (Drug)
LiRIS Placebo, LiRIS® (Tx 1)/ LiRIS® (Tx 2)
Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 0 and then removed and LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 14 then removed on Day 28. Treatment 2 Period: optional LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 then removed on Day 14.
干预措施: LiRIS Placebo (Drug)
结局指标
主要结局
Change From Baseline in the Daily Average Bladder Pain Numeric Rating Scale (NRS)
时间窗: Baseline (Day -7 to Day 0) to Week 4
The participant recorded their daily bladder pain score over the previous 24-hour period on a 7-day pain assessment tool as measured by an NRS on an 11-point scale where 0=no pain to 10=worst pain imaginable. The daily pain scores 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 (baseline bladder pain NRS: ≤ 5 or \> 5) as factors was used for analysis.
次要结局
- Change From Baseline in the Number of Hunner's Lesions(Baseline (Day 0) to Week 4)
- Change From Baseline in Composite Score of Hunner's Lesions Calculated Based on Number, Size, and Severity of Lesions(Baseline (Day 1) to Week 4)