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A Comparative Study of KHK6188

Primary Purpose

Postherpetic Neuralgia

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
KHK6188
Placebo
Sponsored by
Kyowa Kirin Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postherpetic Neuralgia

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Japan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

KHK6188, high dose

KHK6188, low dose

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change of pain intensity score

Secondary Outcome Measures

Change of allodynia severity
Change of global impression

Full Information

First Posted
February 21, 2012
Last Updated
October 8, 2013
Sponsor
Kyowa Kirin Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01544296
Brief Title
A Comparative Study of KHK6188
Official Title
Phase II Study of KHK6188 (A Placebo-controlled, Double Blind, Crossover Study of KHK6188 in Postherpetic Neuralgia)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postherpetic Neuralgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
KHK6188, high dose
Arm Type
Experimental
Arm Title
KHK6188, low dose
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
KHK6188
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change of pain intensity score
Time Frame
baseline and 2weeks
Secondary Outcome Measure Information:
Title
Change of allodynia severity
Time Frame
baseline and 2 weeks
Title
Change of global impression
Time Frame
baseline and 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Japan
City
Arakawa-ku
State/Province
Tokyo
Country
Japan

12. IPD Sharing Statement

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A Comparative Study of KHK6188

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