URG101 Pharmacodynamic and Safety Study: A Randomized, Double-blind, Placebo-controlled, Multi-center Cross-over Study to Investigate the Pharmacodynamic Profile of URG101 in Subjects With Pelvic Pain of Bladder Origin.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 28
- 试验地点
- 6
- 主要终点
- Change in Daytime Bladder Pain Intensity
研究概览
简要总结
A double-blind, placebo-controlled study to evaluate changes in pain, urgency and urinary frequency following administration of URG101 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male and female subjects >= 18 years of age
- •moderate to severe symptoms of PBS/IC
- •minimum pain/urgency/frequency scores
- •female subjects on hormone therapy must be on stable dose for >= 3 months
排除标准
- •positive pregnancy test or pregnant or lactating
- •narcotics or medical marijuana within 3 months
- •use of any investigational drug or device within 30 days
- •bacterial cystitis within 30 days
研究组 & 干预措施
Crossover
Placebo Treatment on Visit 1 followed by URG101 Treatment on Visit 2
干预措施: URG101 (Drug)
Crossover
Placebo Treatment on Visit 1 followed by URG101 Treatment on Visit 2
干预措施: Placebo (Drug)
Crossover 2
URG101 Treatment on Visit 1 followed by Placebo Treatment on Visit 2
干预措施: URG101 (Drug)
Crossover 2
URG101 Treatment on Visit 1 followed by Placebo Treatment on Visit 2
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Daytime Bladder Pain Intensity
时间窗: Through 12 hours
A calculation of average bladder pain intensity differences from baseline to 12 hours post-dose , as determined using an 11-point numerical rating scale (NRS) for bladder pain from time of dosing through 12 hours post dose. The 11-point NRS for bladder pain is a scale from 0 to 10, with 0 indicating no bladder pain and 10 indicating the worst imaginable bladder pain.
次要结局
- Change in Question 3 of the Patient Overall Rating of Improvement of Symptoms (PORIS) Questionnaire(Through 12 hours)
- Change in Daytime Urinary Urgency Score(Through 12 hours)
- Change in Total Symptom Score(Through 12 hours)