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A Comparative Study of KHK6188

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01544296
Recruitment Status : Completed
First Posted : March 5, 2012
Last Update Posted : October 10, 2013
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Postherpetic Neuralgia Drug: KHK6188 Drug: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase II Study of KHK6188 (A Placebo-controlled, Double Blind, Crossover Study of KHK6188 in Postherpetic Neuralgia)
Study Start Date : February 2012
Primary Completion Date : June 2013
Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: KHK6188, high dose Drug: KHK6188
Experimental: KHK6188, low dose Drug: KHK6188
Placebo Comparator: Placebo Drug: Placebo

Outcome Measures

Primary Outcome Measures :
  1. Change of pain intensity score [ Time Frame: baseline and 2weeks ]

Secondary Outcome Measures :
  1. Change of allodynia severity [ Time Frame: baseline and 2 weeks ]
  2. Change of global impression [ Time Frame: baseline and 2 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01544296

Arakawa-ku, Tokyo, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Co., Ltd
More Information

Responsible Party: Kyowa Hakko Kirin Co., Ltd
ClinicalTrials.gov Identifier: NCT01544296     History of Changes
Other Study ID Numbers: 6188-004
First Posted: March 5, 2012    Key Record Dates
Last Update Posted: October 10, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Neuralgia, Postherpetic
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms