A Comparative Study of KHK6188

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a placebo-controlled, double blind, crossover study to evaluate the efficacy and safety of KHK6188 in postherpetic neuralgia when administered orally for 2 weeks.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyowa Hakko Kirin Company, Limited; Kyowa Kirin Co., Ltd.

Criteria

Inclusion Criteria:

• Patients with pain for ≥ 3 months and ≤ 1 year following onset of a herpes zoster rash

• Patients with a mean pain intensity score (11-point numerical rating scale) of ≥ 4

• 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:

• Patients 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