NCT00889642已完成2 期
A Multicenter Double-Blind Randomized Placebo Controlled Two-Arm Study Evaluating the Safety and Efficacy of the Iontophoretic Administration of Lidocaine and Epinephrine Using Lidocaine Iontophoretic Drug Delivery System (IDDS) to Provide Local Anesthesia for Venipuncture in Healthy Adult Volunteer Subjects
Dharma Therapeutics Inc.4 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2009年5月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- Following the iontophoresis treatment an IV will be inserted into the treatment area and the amount of pain will be assessed using the median visual analog pain scale (VAS).
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of administering Lidocaine and Epinephrine using an iontophoretic device treatment to provide local anesthesia to healthy adult volunteer subjects undergoing venipuncture.
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
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects may be of any race, either sex, and must be >18 years of age
- •Healthy subjects as per medical screening
- •Subjects must have intact, healthy skin (no tattoos, surgical scars, skin infections, etc.) where the iontophoresis treatment will be performed
- •Subjects must be alert, oriented, mentally competent, and able to understand and comply with the requirements of the study
- •Subjects must have signed and dated a written informed consent
- •Female subjects of childbearing potential must have a negative pregnancy test result prior to the iontophoresis treatment
排除标准
- •Subjects with a known allergy or sensitivity to lidocaine, epinephrine or other local anesthetics of the amide or ester type
- •Subjects with a know sensitivity to any components (e.g. adhesives) of the IDDSSubjects who have undergone venipuncture in the treatment area within the prior 2 weeks or longer if bruising or hematoma is apparent
- •Subjects who have taken an analgesic pain medication during the 24-hour period prior to the venipuncture in the posterior surface of the hand
- •Subjects with skin allergies or have skin diseases (e.g. psoriasis, eczema
- •Subjects with an open skin lesion at the treatment site
- •Subjects who are pregnant or breastfeeding
- •Subjects exposed to an investigational drug or device within the past 30 days or are involved concurrently in other treatment clinical trials
- •Subjects who participated in previous DTI/Transcu clinical studies related to this product
- •Subjects with known concurrent illness
- •Subjects with "current" known/admitted substance abuse (alcohol/drug)
- •Subjects with pacemakers and/or externally mounted electronic devices
- •Current or history of conditions that contraindicate use of iontophoretic treatment or venipuncture
结局指标
主要结局
Following the iontophoresis treatment an IV will be inserted into the treatment area and the amount of pain will be assessed using the median visual analog pain scale (VAS).
时间窗: 4 hours
Monitor the nature and frequency of adverse events associated with the iontophoretic device through observation during treatment.
时间窗: 4 hours
次要结局
- Determining the duration of anesthesia through standard pin prick testing.(4 hours)
研究者
研究点 (4)
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