A Comparative Study of KHK6188

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:
NCT01544296
First received: February 21, 2012
Last updated: October 8, 2013
Last verified: October 2013
  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:


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
Study Completion Date: June 2013
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: October 8, 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 August 18, 2014