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A Comparative Study of KHK6188

NCT ID: NCT01544296

Last Updated: 2013-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-06-30

Brief Summary

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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

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Conditions

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Postherpetic Neuralgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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KHK6188, high dose

Group Type EXPERIMENTAL

KHK6188

Intervention Type DRUG

KHK6188, low dose

Group Type EXPERIMENTAL

KHK6188

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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KHK6188

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyowa Kirin Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Japan

Arakawa-ku, Tokyo, Japan

Site Status

Countries

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Japan

Other Identifiers

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6188-004

Identifier Type: -

Identifier Source: org_study_id