A Phase 2 Randomized, Double-blind, Placebo-controlled, Adaptive Study to Evaluate the Efficacy, Safety, and Tolerability of 2 Dose Levels of IW-3300 Administered Rectally for 12 Weeks to Treat Bladder Pain in Subjects With Interstitial Cystitis/Bladder Pain Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 98
- 试验地点
- 47
- 主要终点
- Change from baseline (CFB) in weekly average of daily bladder pain (which can include sensations like burning, pressure, and/or discomfort) at its worst at Week 12
研究概览
简要总结
The aim of this study is to assess whether IW-3300 is safe and works for the treatment of interstitial cystitis/bladder pain syndrome (IC/BPS). The main question the study aims to answer is whether IW-3300 helps bladder pain and other symptoms (for example, bladder burning, pressure and discomfort). Subjects will be assigned to receive either the study drug or placebo by chance.
详细描述
This is a Phase 2, randomized, placebo-controlled, parallel-assignment, 12-week, adaptive design study to evaluate the efficacy, safety, and tolerability of IW-3300 in subjects with IC/BPS. Subjects will be randomized 1:1:1 to IW-3300 100 µg, IW-3300 300 µg, or matching placebo administered as a rectal foam. The study has 4 periods, which are the screening (up to 30 days), pretreatment (up to 21 days), study treatment (12 weeks), and follow-up periods (2 weeks) which consists of 7 onsite study visits and 1 follow-up phone call. Subjects will administer the study drug at home for 12 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with IC/BPS by a urologist or other clinician specializing in IC/BPS
- •Chronic bladder pain associated with filling the bladder over the past 6 months
- •Compliant with eDiary completion and meets weekly average daily score for bladder pain at its worst during the pretreatment period
- •Has at least 1 of the following urinary symptoms over the past 6 months: nocturia ≥2 voids/night, daytime frequency >8×day, urgency
- •Body mass index (BMI) ≤40 kg/m2
- •Willing to use a rectally administered product once daily for 12 weeks
排除标准
- •Male subject has history of bacterial prostatitis or benign prostatic hyperplasia with active symptoms that are difficult to distinguish from IC/BPS
- •Has a condition that can be a contraindication to using a rectal foam
- •Has cancer under active treatment or a history of uterine, cervical, pelvic, colorectal, ovarian, or vaginal cancer
- •Has a history of benign or malignant bladder tumors
- •Has an active urinary tract infection or had ≥2 UTIs within the past 90 days
- •Has an uncontrolled major psychiatric condition or has made a suicide attempt during the past 2 years
- •Has a malabsorption syndrome
- •Had surgery in the pelvic or abdominal region within the past 90 days or is planning pelvic or abdominal region surgical procedures before the end of the study
- •Has received a cystoscopy with or without hydrodistension for diagnostic purposes (ie, not for pain relief) within the past 30 days or a cystoscopy with therapeutic hydrodistension (ie, for pain relief) within the past 90 days or is planning a cystoscopy for any reason before the end of the study
- •Has history of pelvic irradiation or radiation cystitis, or drug-induced cystitis.
- •Has a recent history of drug or alcohol abuse
研究组 & 干预措施
IW-3300 100 µg
IW-3300 at 100 µg rectal foam administered daily for 12 weeks
干预措施: IW-3300 rectal foam (Drug)
IW-3300 300 µg
IW-3300 at 300 µg rectal foam administered daily for 12 weeks
干预措施: IW-3300 rectal foam (Drug)
Placebo
Placebo rectal foam administered daily for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline (CFB) in weekly average of daily bladder pain (which can include sensations like burning, pressure, and/or discomfort) at its worst at Week 12
时间窗: Baseline, Week 12
Subject assessment of bladder pain at its worst will be reported via a daily electronic Diary (eDiary)
次要结局
- CFB in Genitourinary Pain Index (GUPI) Pain subscale score at Week 12(Baseline, Week 12)
- CFB in weekly average of a pressure sensation in the bladder at its worst at Week 12(Baseline, Week 12)
- CFB in weekly average of discomfort in the bladder at its worst at Week 12(Baseline, Week 12)
- Frequency of Treatment-emergent adverse events (TEAEs) occurring in ≥2% of subjects(Baseline, Week 12)
- Overall frequency of TEAEs by severity grade(Baseline, Week 12)
- CFB in weekly average of a burning sensation in the bladder at its worst at Week 12(Baseline, Week 12)