A Phase 1b, Multicenter, Open Label Study Evaluating Safety, Tolerability and Preliminary Efficacy of LiRIS® 400 mg in Women With Ulcerative Interstitial Cystitis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 14
研究概览
简要总结
The purpose of the study is to evaluate if LiRIS 400 mg is safe and tolerable when administered to women with Interstitial Cystitis with Hunner's lesions, and to evaluate any change in the bladder or in IC symptoms, following LiRIS administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Women age 18 and older
- •Interstitial Cystitis with history of Hunner's lesions in the bladder
- •Moderate to severe bladder discomfort
- •Confirmation of Hunner's lesions in Bladder
- •Able to report symptom (pain and voiding frequency) in a diary throughout the study
排除标准
- •Pregnant women
- •History or presence of bladder cancer
- •History or presence of any condition that would make it difficult to evaluate bladder symptoms
研究组 & 干预措施
LiRIS® 400 mg
LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period.
干预措施: LiRIS® 400 mg (Drug)
结局指标
主要结局
Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 14
时间窗: Baseline, Day 14
The appearance of the Hunner's lesions was assessed by the investigator using video capture of the bladder mucosa during the cystoscopic examinations. Complete responders (CR)=no lesions observed at day of last LiRIS removal; Partial responders (PR)=presence of residual lesions on day of last LiRIS removal however there is cystoscopic evidence of a decrease in either: i) the affected area as calculated by size and dimension of individual lesions summed together or ii) the lesion number or iii) the lesion(s) severity (mild, moderate, severe) as compared with Baseline assessment; Stable Disease=no change in the appearance of lesions and no new lesions on day of last LiRIS removal compared with Baseline assessment; Non-responders=worsening of mucosal appearance on day of last LiRIS removal.
Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 28
时间窗: Baseline, Day 28
The appearance of the Hunner's lesions was assessed by the investigator using video capture of the bladder mucosa during the cystoscopic examinations. Complete responders (CR)=no lesions observed at day of last LiRIS removal; Partial responders (PR) = presence of residual lesions on day of last LiRIS removal however there is cystoscopic evidence of a decrease in either i) the affected area as calculated by size and dimension of individual lesions summed together or ii) the lesion number or iii) the lesion(s) severity (mild, moderate, severe) as compared with Baseline assessment; Stable Disease=no change in the appearance of lesions and no new lesions on day of last LiRIS removal compared with Baseline assessment; Non-responders=worsening of mucosal appearance on day of last LiRIS removal.
次要结局
- Change From Baseline in Patient Reported Interstitial Cystitis (IC) Symptom: Average Bladder Pain(Baseline, during treatment (Days 7, 14, 20, 28) and during follow up (Weeks 1, 2, 4, 8, 12))
- Change From Baseline in Patient Reported IC Symptom: Daily Total Voids(Baseline, during treatment (Days 7, 14, 20, 28) and during follow-up (Weeks 1, 2, 4, 8, 12))