A Phase 2a Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating Safety, Tolerability and Efficacy of LiRIS® 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
- 104
- 试验地点
- 29
- 主要终点
- Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 14
研究概览
简要总结
The purpose of this study is to determine if LiRIS®, an investigational drug-delivery system, is safe, tolerable and effective in women with Interstitial Cystitis. LiRIS® is inserted into the bladder via cystoscopy , remains in the bladder for 14 days, and is removed via cystoscopy.
详细描述
The study is conducted in 2 parts - a randomized, blinded part in which patients are randomly assigned to one of 3 possible arms (LiRIS® - contains lidocaine), LiRIS Placebo (LiRIS with inactive substance) or Sham(Insertion procedure only with neither LiRIS nor LiRIS Placebo), followed by an open extension part in which all patients are assigned to receive LiRIS® (with lidocaine). In part 1 of the study, treatment is managed in a double-blind manner for LiRIS® and LiRIS Placebo arms; and in a single-blind manner for the Sham arm (e.g.,the study doctor will know the treatment assignment for patients assigned to Sham).
All patients who complete part 1 of the study have the option to enter the extension.
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
- Quadruple (Participant, Care Provider, 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
- •Women age 18 and over
- •Diagnosed with Interstitial Cystitis as defined by protocol
- •Able and willing to complete questionnaires and diary
- •Able to comply with visit schedule including Day 14 Removal visit
- •Completion of blinded study prior to enrolling in unblinded part of study
排除标准
- •Pregnant or lactating women
- •Bladder or urethra anatomical feature that would prevent the safe indwelling or insertion of the investigational product
- •History or presence of any condition that would make it difficult to evaluate symptoms
- •Did not complete blinded study (unblinded part of study only)
研究组 & 干预措施
Lidocaine Releasing Intravesical System
Lidocaine Releasing Intravesical System (LiRIS®) is inserted into the bladder via cystoscopy on Study Day 0 and removed on Study Day 14. LiRIS releases lidocaine gradually during the 14 day indwelling period.
干预措施: Lidocaine Releasing Intravesical System - LiRIS® (Drug)
LiRIS containing inactive substance only
LiRIS Placebo is inserted into the bladder via cystoscopy on study Day 0 and removed via cystoscopy on study Day 14.
干预措施: LiRIS Placebo (Other)
Cystoscopy Procedure
No intervention. Cystoscopy procedure is performed on study Day 0 and study Day 14 to mimick active and placebo study arms without insertion of Investigational Product into the bladder.
干预措施: Sham Cystoscopy Procedure (Procedure)
结局指标
主要结局
Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 14
时间窗: Baseline, Day 14
Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement.
Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 42
时间窗: Baseline, Day 42
Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement.
Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 7
时间窗: Baseline, Day 7
Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter (cm) horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement.
Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) ay Day 28
时间窗: Baseline, Day 28
Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement.
次要结局
- Change From Baseline in Urinary Urgency as Assessed by VAS(Baseline, Days 7, 14, 28 and 42)
- Change Form Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score(Baseline, Days 7, 14, 28 and 42)
- Change From Baseline in Voiding Frequency(Baseline, Days 7, 14, 28 and 42)
- Change From Baseline in Interstitial Cystitis Problem Index (ICPI) Score(Baseline, Days 7, 14, 28 and 42)
- Percentage of Participants With Change From Baseline in Cystoscopic Examination Findings(Baseline, Day 14)
- Percentage of Responders Using the Global Response Assessment (GRA)(Baseline, Days 7, 14, 28 and 42)