A Comparative Study of KHK6188

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

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.

Study Overview

• Status: Completed
• Conditions: Postherpetic Neuralgia
• Intervention / Treatment: Drug: Placebo; Drug: KHK6188

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Tokyo
    • Arakawa-ku, Tokyo, Japan
      • Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo
EXPERIMENTAL: KHK6188, high dose	Drug: KHK6188
EXPERIMENTAL: KHK6188, low dose	Drug: KHK6188

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change of pain intensity score	baseline and 2weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Kyowa Kirin Co., Ltd.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (ACTUAL): June 1, 2013
• Study Completion (ACTUAL): June 1, 2013

Study Registration Dates

• First Submitted: February 21, 2012
• First Submitted That Met QC Criteria: March 2, 2012
• First Posted (ESTIMATE): March 5, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 10, 2013
• Last Update Submitted That Met QC Criteria: October 8, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Neuralgia, Postherpetic
• Other Study ID Numbers: 6188-004