NCT00576108已完成2 期
A 2 Week Study of Topical KD7040 in the Treatment of Postherpetic Neuralgia (PHN)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Worst daily pain
研究概览
简要总结
This study will evaluate the safety and efficacy of 2 weeks of topical KD7040 versus placebo in the treatment of postherpetic neuralgia.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male or female subjects ages 18-85 years
- •Previous diagnosis of Shingles (Herpes Zoster) with pain persisting for at least 3 months, but not longer than 5 years, after healing of rash
- •Subject with intact skin in the targeted treatment area
- •Female subjects of childbearing potential must have a negative serum pregnancy test at screening, a negative urine human chorionic gonadotropin (hCG) test prior to randomization, and must use medically acceptable methods of birth control. All subjects must agree to take every precaution to ensure that pregnancy will not occur during the study.
- •Subject must be willing and able to complete screening and study procedures as described int he protocol.
- •Subject must voluntarily provide written Informed Consent prior to participation.
排除标准
- •Subjects with known hypersensitivity to KD7040 or methylparaben, or previous exposure to KD
- •Subjects pregnant, nursing or planning to become pregnant.
- •Subjects who are immunocompromised or have clinically significant hematological abnormalities.
- •Subjects with system dermatological conditions (e.g., psoriasis, atopic dermatitis) or impaired wound healing.
- •Subjects who have had local anesthetic nerve blocks within 48 hours of study entry.
- •Subjects having other sever pain which may confound assessment of PHN.
- •Subjects who have serious, unstable, or clinically significant medical or psychological conditions, which, in the opinion of the Investigator(s) would compromise the subjects' participation in the study.
研究组 & 干预措施
KD7040 topical gel
Experimental
干预措施: KD7040 Topical Gel (Drug)
Placebo gel
Placebo Comparator
干预措施: Placebo gel (Drug)
结局指标
主要结局
Worst daily pain
时间窗: Once daily
次要结局
- Average daily pain(Once daily)
研究者
研究点 (1)
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