A Phase Ib Pilot Multiple Dose, Randomized-Withdrawal, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Pharmacokinetics of Topically Applied 40% Lidocaine Gel Compared With Placebo in Subjects With Acute Herpes Zoster Pain
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- To evaluate the safety of topically applied 40% lidocaine gel measuring incidence, intensity, relationship, and seriousness of treatment-emergent AEs
研究概览
简要总结
Study 2022-HZ-011 will utilize a randomized withdrawal (RW), double-blind, placebo controlled design in which the PK and safety of CNTX 2022 (40% anhydrous lidocaine gel) will be evaluated in subjects with acute-onset herpes zoster pain.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is a male or female ≥ 18 years of age and ≤ 85 years of age.
- •Subject has brush-evoked allodynic pain intensity score ≥ 4 using the NPRS as determined by pain assessment during the physical examination at screening.
- •a. Onset must have occurred ≤ 20 days prior to randomization
- •Subject has an average daily pain intensity score of ≥ 4 using the NPRS as determined by pain assessment during the physical examination at screening.
- •Subject must have a diagnosis of herpes zoster (shingles).
- •Subject has rash limited to trunk and limbs, with a total surface area of up to 300 cm2.
排除标准
- •Subject has an active herpes zoster lesion on the face, head, neck, genital or rectal areas.
- •Subject has rash limited to trunk and limbs, with a total surface area greater than 300 cm
- •Subject has a known history of allergic reaction, hypersensitivity, or clinically significant intolerance to lidocaine, ingredients of the study drug, or local anesthetics of the amide type.
- •Subject has target skin area (allodynic area and surrounding skin) that is not intact, is inflamed, or in the opinion of the Principal Investigator, consistent with rash due to acute herpes zoster.
- •Subject has any other form of pain that was not discernible from herpes zoster (shingles) allodynia.
- •Subject is taking Class I antiarrhythmic drugs (e.g., tocainide, mexiletine), or medications that could interact with the study drug or interfere with its evaluation.
研究组 & 干预措施
CNTX-2022 (lidocaine gel, 40%)
Application of 1mL CTNX-2022 (40% Anhydrous Lidocaine Gel) topically applied to 300cm squared outlined area once daily (in the morning) for 8 days at the study site.
干预措施: CNTX-2022 (lidocaine gel, 40%) (Drug)
Placebo
Application of 1mL placebo topically applied to 300cm squared outlined area once daily (in the morning) for 8 days at the study site.
干预措施: Placebo (Drug)
结局指标
主要结局
To evaluate the safety of topically applied 40% lidocaine gel measuring incidence, intensity, relationship, and seriousness of treatment-emergent AEs
时间窗: 28 days
To evaluate the pharmacokinetics of topically applied 40% lidocaine gel measuring Tmax
时间窗: 28 days
次要结局
- To assess the effect of 40% lidocaine gel on 0-10 numeric pain rating scale (NPRS) scores related to acute herpes zoster(28 days)