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A Comparative Study of KHK6188

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:
NCT01544296
First received: February 21, 2012
Last updated: May 21, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention Phase
Postherpetic Neuralgia
 Drug: KHK6188
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Phase II Study of KHK6188 (A Placebo-controlled, Double Blind, Crossover Study of KHK6188 in Postherpetic Neuralgia)

Resource links provided by NLM:

MedlinePlus related topics: Shingles
U.S. FDA Resources

Further study details as provided by Kyowa Hakko Kirin Company, Limited:

Primary Outcome Measures:
  • Change of pain intensity score [ Time Frame: baseline and 2weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change of allodynia severity [ Time Frame: baseline and 2 weeks ] [ Designated as safety issue: No ]
  • Change of global impression [ Time Frame: baseline and 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: February 2012
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KHK6188, high dose Drug: KHK6188
Experimental: KHK6188, low dose Drug: KHK6188
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01544296

Locations
Japan
Japan
Arakawa-ku, Tokyo, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Company, Limited
  More Information

No publications provided

Responsible Party: Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier: NCT01544296     History of Changes
Other Study ID Numbers: 6188-004
Study First Received: February 21, 2012
Last Updated: May 21, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on June 18, 2013