A Comparative Study of KHK6188

Phase 2

Completed

• Conditions: Postherpetic Neuralgia
• Interventions: Drug: KHK6188; Drug: Placebo

• Registration Number: NCT01544296
• Lead Sponsor: Kyowa Kirin Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-21
• Study First Submitted QC: 2012-03-02
• Study First Posted: 2012-03-05
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-08
• Last Update Posted: 2013-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
KHK6188, low dose	KHK6188	-
Placebo	Placebo	-
KHK6188, high dose	KHK6188	-

Primary Outcome Measures

Name	Time	Method
Change of pain intensity score	baseline and 2weeks

Secondary Outcome Measures

Name	Time	Method
Change of allodynia severity	baseline and 2 weeks
Change of global impression	baseline and 2 weeks

Trial Locations

Locations (1)

Japan; 🇯🇵 Arakawa-ku, Tokyo, Japan