A Comparative Study of KHK6188

Kyowa Kirin

Status and phase

Completed

Phase 2

Conditions

Postherpetic Neuralgia

Treatments

Drug: Placebo

Drug: KHK6188

Study type

Interventional

Funder types

Industry

Identifiers

NCT01544296

6188-004

Details and patient eligibility

About

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.

Enrollment

42 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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