Phase II study of KHK6188 (A placebo-controlled, double blind, crossover study of KHK6188 in postherpetic neuralgia)

Kyowa Hakko Kirin Co., Ltd.0 个研究点目标入组 42 人开始时间: 2012年2月21日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•Patients with pain for 3 months or more and 1 year or less following onset of a herpes zoster rash
•- Patients with a mean pain intensity score (11-point numerical rating scale) of 4 or more
•- Patients whose rash has been healed
•- Patients who are able to fill their patient diary
•- Patients who provided written voluntary informed consent to participate in the study

•- Patiens who have other pain or disease which may impair the self assessment of pain
•- Patients who have dementia, depression or schizophrenia which may affect the self assessment of pain
•- History or presence of severe cardiovascular disease, hepatic dysfunction, renal failure, respiratory disease, blood disease or CNS disorder
•- History or presence of a drug allergy
•- Patients who have a history of a diagnosis of cancer or a treatment of cancer within 5 years prior to the study entry
•- Patients received an investigational medication within 4 months (6 months for biologic medication such as antibody) prior to the informed consent
•- Women of child bearing potential who do not agree to avoid pregnancy from the time of providing the consent until 3 months after the end of dosing, or men of reproductive potential who do not agree to avoid pregnancy from the time of the first dose until 3 months after the end of dosing
•- Patients who are pregnant, lactating, or possibly pregnant
•- Patients judged to be inappropriate to enter the study by a investigator or a subinvestigator

发起方

Kyowa Hakko Kirin Co., Ltd.