A Comparative Study of KHK6188

Phase II Study of KHK6188 (A Placebo-controlled, Double Blind, Crossover Study of KHK6188 in Postherpetic Neuralgia)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01544296

Enrollment

Registered

2012-03-05

Start date

2012-02-29

Completion date

2013-06-30

Last updated

2013-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postherpetic Neuralgia

Brief 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.

Interventions

DRUGKHK6188

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Change of pain intensity score	baseline and 2weeks

Secondary

Measure	Time frame
Change of allodynia severity	baseline and 2 weeks
Change of global impression	baseline and 2 weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026