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

February 21, 2012
October 8, 2013
February 2012
June 2013   (final data collection date for primary outcome measure)
Change of pain intensity score [ Time Frame: baseline and 2weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01544296 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Postherpetic Neuralgia
  • Drug: KHK6188
  • Drug: Placebo
  • Experimental: KHK6188, high dose
    Intervention: Drug: KHK6188
  • Experimental: KHK6188, low dose
    Intervention: Drug: KHK6188
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01544296
6188-004
No
Kyowa Hakko Kirin Company, Limited
Kyowa Hakko Kirin Company, Limited
Not Provided
Not Provided
Kyowa Hakko Kirin Company, Limited
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP