ACTRN12618000852257已完成2 期
A Phase II, randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of topical lidocaine spray in patients with Postherpetic Neuralgia
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Female of non-childbearing potential (ie, 12 months or more of spontaneous
- •amenorrhea, bilateral oophorectomy at least 6 months prior to
- •randomisation, hysterectomy with bilateral oophorectomy at least 6 months
- •prior to randomisation, or for females over 50 years of age, hysterectomy
- •without bilateral oophorectomy at least 6 months prior to randomisation).
- •2. Females of childbearing potential must be confirmed to be not pregnant at
- •3. Males with sexual partners or females of childbearing potential must agree to
- •use an effective contraceptive method (abstinence, birth control pills, rings or
- •patches, diaphragm, intrauterine device, condom, surgical sterilization,
- •vasectomy, or progestin implant or injection) from screening to the end of
- •study, and for 1 month after exiting the study.
- •4. Persistent pain for more than 3 months from the appearance of herpes zoster
- •rash that is not located on the face, above the scalp hairline, or in proximity to
- •mucous membranes.
- •5. Diagnosis of PHN based on medical history as judged by investigator.
- •6. Persistent neuropathic pain that involves at least 1 dermatome and covering
- •no more than 420 cm2
- •7. If the subject has been on stable dose(s) of oral analgesic medication for at
- •least 30 days prior to the screening visit, they need to be willing to maintain
- •the respective dose(s) and medication throughout the study.
- •8. Pain intensity score in the target area of >=4 at both screening and the
- •randomisation visit. The pain intensity score for a subject may be reevaluated
- •if it is not >=4 at the randomisation visit.
- •9. Skin is intact over the painful area to be treated.
排除标准
- •1. Subject has systemic disease that would put him/her at an additional risk or limit his/her ability to participate in the study as judged by the investigator.
- •2. Subject has a history of human immunodeficiency virus, hepatitis C, or hepatitis B.
- •3. Subject has a history of malignancy other than basal cell carcinoma and carcinoma in situ within the past 2 years.
- •4. Subject has a history of mental illness or psychiatric illness such as dementia, depression, or schizophrenia, that can limit his/her ability to comply with study procedures as judged by the investigator.
- •5. Subject is unable to apply, or have a caregiver apply, study spray to the most painful skin segments twice a day as directed.
- •6. Subject has known sensitivity to lidocaine containing products.
- •7. Subject has active herpes zoster lesions or dermatitis.
- •8. Subject has other condition(s) that cause severe or chronic pain that may impair the self-assessment of the pain due to PHN as judged by the investigator.
- •9. Subject was treated in the area of PHN with a local anaesthetic within 14 days of Baseline or had a nerve block within 30 days of Baseline
- •10. Subject is receiving any prohibited medication or therapy and is unable to washout these medications or therapies for the duration of the study.
- •11. Subject has used capsaicin patches within 90 days of Baseline or has used other capsaicin preparations on a daily basis in the 90 days prior Baseline.
- •12. Pregnant or lactating females.
- •13. Subject has an active history of alcohol or drug abuse.
- •14. Subject has participated in any other investigational study within 30 days prior to screening.
- •15. Subject or subject’s direct family is employed by the sponsor or study staff.
- •16. Subject has any condition that would make him/her unsuitable for the study
- •in the opinion of the investigator or sponsor.
研究者
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