Phase 1B Pilot Safety Study of LiRIS-TM, A Novel Bladder Drug Delivery Platform in Patients With Interstitial Cystitis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 18
- 试验地点
- 3
- 主要终点
- Cystoscopic examination
研究概览
简要总结
The purpose of this study is primarily to evaluate the safety and tolerability of two dose levels of an investigational drug-delivery system (LiRIS) in patients who have moderate to severe symptoms of interstitial cystitis.
详细描述
Approximately 20 female patients with interstitial cystitis will be enrolled in this study at multiple centers in Canada. LiRIS is being developed to provide drug therapy directly into the urinary bladder. LiRIS contains Lidocaine, a marketed drug (approved by Health Canada) which is commonly used for local (skin or oral)anaesthesia. LiRIS is designed to release a controlled amount of lidocaine while in the bladder over a 2 week period.
Two dose groups of approximately 10 patients per group will be enrolled into the study; the first group of patients will receive low dose LiRIS, and the second group will receive high dose LiRIS. All patients receive LiRIS treatment for 14 days, and clinic follow-up at 7 and 14 days after treatment. Additional telephone follow-up occurs at approximately 6 and 10 weeks after LiRIS treatment. The maximum duration of participation, including a screening period of up to 14 days, will be 104 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Female patients ≥ 18 years of age
- •If of child-bearing potential, agrees to use effective contraception defined by protocol
- •Capable of understanding and completing symptom diaries and questionnaires as required in the study
- •Diagnosed with IC, as defined by protocol criteria
排除标准
- •Bladder or urethra anatomical feature that, in the opinion of the investigator, might prevent the safe placement, indwelling use, or removal of LiRIS
- •History or presence of any medical condition that would interfere with ability to assess symptoms
- •Pregnant or lactating patients
研究组 & 干预措施
LiRIS low dose
The first dose group of approximately 10 patients receive low dose LiRIS on Day 1 to Day 14.
干预措施: LiRIS low dose and LiRIS high dose (Drug)
LiRIS high dose
The second dose group of approximately 10 patients receive high dose LiRIS on Day 1 to Day 14.
干预措施: LiRIS low dose and LiRIS high dose (Drug)
结局指标
主要结局
Cystoscopic examination
时间窗: Days 1 and 14
次要结局
- Bladder pain(During and following treatment; study days 1 to 90)