Postherpetic neuralgia
Conditions
Interventions
investigational material(s)
Generic name etc : KHK6188
INN of investigational material : -
Therapeutic category code : 114 Antipyretics, analgesics and anti-inflammatory agents
Dosage and Administrati
Sponsors
Kyowa Hakko Kirin Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy, Safety Efficacy: Change of pain intensity score Safety: adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Allodynia, Global impression Change of allodynia severity, change of global impression | — |
Outcome results
None listed