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

Tracking Information
First Received Date ^ICMJE	February 21, 2012
Last Updated Date	May 21, 2013
Start Date ^ICMJE	February 2012
Estimated Primary Completion Date	June 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 2, 2012)	Change of pain intensity score [ Time Frame: baseline and 2weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01544296 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 2, 2012)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Comparative Study of KHK6188
Official Title ^ICMJE	Phase II Study of KHK6188 (A Placebo-controlled, Double Blind, Crossover Study of KHK6188 in Postherpetic Neuralgia)
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Postherpetic Neuralgia
Intervention ^ICMJE	Drug: KHK6188 Drug: Placebo
Study Arm (s)	Experimental: KHK6188, high dose Intervention: Drug: KHK6188 Experimental: KHK6188, low dose Intervention: Drug: KHK6188 Placebo Comparator: Placebo Intervention: Drug: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	42
Completion Date	Not Provided
Estimated Primary Completion Date	June 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	20 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Japan

Administrative Information
NCT Number ^ICMJE	NCT01544296
Other Study ID Numbers ^ICMJE	6188-004
Has Data Monitoring Committee	No
Responsible Party	Kyowa Hakko Kirin Company, Limited
Study Sponsor ^ICMJE	Kyowa Hakko Kirin Company, Limited
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Kyowa Hakko Kirin Company, Limited
Verification Date	May 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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