NCT00857090已完成1 期
Double-Blind, Placebo-Controlled, Concentration-Escalating, Pharmacokinetic Study Evaluating the Systemic Absorption, Safety, and Efficacy of OMS201 in Subjects Undergoing Ureteroscopic Treatment of Ureteral- or Renal Collecting System-Located Stones
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 4
- 主要终点
- Peak systemic exposure.
研究概览
简要总结
The objectives of the study are to assess the systemic exposure, safety and efficacy of three concentrations of OMS201 in subjects undergoing retrograde ureteroscopic removal of upper urinary tract stones.
详细描述
The main objective is to estimate the systemic exposure of OMS201 in retrograde ureteroscopic treatment of upper urinary tract stones. Safety will be assessed by vital signs, laboratory values and adverse events. Exploratory efficacy measures will assess the effect of OMS201 on postoperative pain, duration of surgery and ease of placement of a ureteral access sheath.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 - 65 years of age.
- •Subject is undergoing retrograde ureteroscopic removal of renal-collecting system or ureteral stones for which general anesthesia will be used.
排除标准
- •No allergies to any of the individual ingredients in OMS
- •Subject taking a prohibited medication.
- •Pregnant woman, nursing mother, or woman of child-bearing age unwilling to take contraception for the duration of the study.
- •Subject who has had a renal transplant, has a single kidney, has compromised renal function, or has evidence of papillary necrosis.
- •Subject who has evidence of a clinically significant urinary tract infection.
- •Subject who has a prior history of open or laparoscopic urinary tract surgery, or a history of a ureteral stricture.
- •Subject who has congenital anomalies that would engender an increased procedural safety risk.
- •Subject with a history of clinically significant chronic or episodic hypotension.
- •Subject's physical examination is significantly abnormal for purposes of the study as determined by the Investigator.
- •Subject's screening laboratory evaluations are not within normal limits AND abnormal results are determined by the Investigator to be clinically significant.
- •Subject is at risk from anesthesia.
- •Subject is on chronic diuretic use.
- •Subject has a present condition or history of any clinically significant medical disorder and is determined by the Investigator to be an unsuitable candidate for receipt of an investigational drug.
研究组 & 干预措施
1
Experimental
Drug
干预措施: OMS201 (Drug)
2
Placebo Comparator
Vehicle
干预措施: Vehicle (Drug)
结局指标
主要结局
Peak systemic exposure.
时间窗: Day of surgery
次要结局
- Degree of pain(7 days)
- Safety(Day 7)
- Duration of the operation(Day of surgery)
- Ease of placement of the ureteral access sheath(Day of surgery)
研究者
研究点 (4)
Loading locations...
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