A Phase 2 Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating Safety, Tolerability and Efficacy of LiRIS® 400 mg in Women With Interstitial Cystitis Followed by an Open Label Extension
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Allergan
- 入组人数
- 31
- 试验地点
- 16
- 主要终点
- Change From Baseline in Participant Reported Average Bladder Pain on a Numerical Rating Scale (NRS)
研究概览
简要总结
The purposes of the study is to determine if LiRIS®, an investigational drug-delivery system, is safe and tolerable in women with Interstitial Cystitis (IC), and to evaluate any change in IC symptoms following LiRIS administration.
详细描述
The study is conducted in 2 parts: a randomized, blinded part in which subjects are assigned randomly (by chance) to LiRIS 400 mg or LiRIS placebo; subjects who complete this part and are eligible to continue, may participate in the open-label part in which all subjects receive LiRIS 400 mg.
In both parts of the study (blinded and open-label), LiRIS is inserted into the bladder during cystoscopy, remains in the bladder for 14 days, and is removed during cystoscopy. In addition to the 14 day period with the LiRIS/LiRIS Placebo, there is a screening period of up to 2 weeks and a follow up period of 4 weeks.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
LiRIS 400 mg
LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days. If eligible, participants could participate in the Open Label Extension where all participants were treated with LiRIS 400 mg.
干预措施: LiRIS 400 mg (Drug)
LiRIS Placebo
LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days. If eligible, participants could participate in the Open Label Extension where all participants were treated with LiRIS 400 mg.
干预措施: LiRIS Placebo (Other)
结局指标
主要结局
Change From Baseline in Participant Reported Average Bladder Pain on a Numerical Rating Scale (NRS)
时间窗: Baseline, Day 12
Participants rated their bladder pain over the previous 24 hours in an electronic diary using a horizontal line NRS by putting a mark on the line where: 0 (the far left of the line)=no pain to 10 (far right of the line)=worst pain imaginable. Bladder pain was averaged over a period of 3 days. A negative change from Baseline indicates improvement.
次要结局
- Change From Baseline in Average Void Volume Per Micturition(Baseline, Day 27)
- Change From Baseline in Brief Pain Inventory (BPI)(Baseline, Day 27)
- Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score(Baseline, Day 27)
- Change From Baseline in Bladder Pain/Interstitial Cystitis Symptom Score (BPIC-SS)(Baseline, Day 27)
- Change From Baseline in Total Daily Voids(Baseline, Day 27)
- Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score(Baseline, Day 27)
- Change From Baseline in Night-Time Daily Voids(Baseline, Day 27)
- Change From Baseline in Post-Void Bladder Pain(Baseline, Day 27)