NCT06285214已完成1 期
Multicenter, Randomized, Double-blind Placebo-controlled, Crossover Study to Investigate Effects of V117957 in Female Subjects With Interstitial Cystitis/Bladder Pain Syndrome
Imbrium Therapeutics24 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2022年5月26日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 24
- 主要终点
- Change From Baseline for Worst Bladder Pain/Discomfort Scores Overnight / Over-the-day
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and efficacy of V117957 in subjects with interstitial cystitis/bladder pain syndrome, compared to placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Female, age ≥18 years and capable of voiding independently. Able to comply with acceptable methods of contraception.
- •Diagnosis of IC/BPS or meets criteria for IC/BPS as defined by the American Urology Association as "an unpleasant sensation (pain, pressure, discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms for more than six weeks duration, in the absence of infection or other identifiable causes".
- •Subject has Bladder Pain/Interstitial Cystitis Symptom Scale (BPIC-SS) total score of ≥19 and worst bladder pain/discomfort sub-score of ≥4 to ≤
- •Has undergone evaluation to rule out other conditions that cause bladder pain/discomfort. Any microscopic or gross hematuria that has not been evaluated in the past 12 months will require appropriate clinical evaluation to determine study eligibility.
排除标准
- •Pelvic floor tenderness in the absence of bladder tenderness on physical examination by primary investigator.
- •Urinary tract infection (UTI) within the past 30 days, or history of recurrent UTI.
- •Hematuria determined to be associated with bladder malignancy or other significant pathology.
- •Had surgical procedure at any time that affected bladder function.
- •Received intravesical therapy or had bladder hydrodistension, fulguration, botulinum toxin, or triamcinolone bladder injection, percutaneous nerve stimulation. A subject receiving such treatment(s) prior to screening is eligible if in the opinion of the investigator the procedure/ treatment resulted in no notable or enduring effect and subject continues to exhibit stable symptomology.
- •Has current or history of clinically significant kidney disease or abnormal kidney function, or nephrolithiasis.
- •Other protocol-specific inclusion and exclusion criteria may apply.
研究组 & 干预措施
V117957
Experimental
干预措施: V117957 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline for Worst Bladder Pain/Discomfort Scores Overnight / Over-the-day
时间窗: Assessed at Baseline, Weeks 2 and 8. Change from Baseline to Week 2 (Period 1) and Week 8 (Period 2) reported.
Each evening and morning the subject responded to the question "Please indicate the worst bladder pain/discomfort you have had overnight/over-the-day" using an 11-point numerical rating scale (NRS) that ranges from 0 = "no bladder pain/discomfort" to 10 = "as bad as you can imagine bladder pain/discomfort."
次要结局
未报告次要终点
研究者
研究点 (24)
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