A Comparative Study of KHK6188

Postherpetic Neuralgia Clinical Trial

Official title:

Phase II Study of KHK6188 (A Placebo-controlled, Double Blind, Crossover Study of KHK6188 in Postherpetic Neuralgia)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01544296
• Other study ID #: 6188-004
• Status: Completed
• Phase: Phase 2
• First received: February 21, 2012
• Last updated: October 8, 2013
• Start date: February 2012
• Est. completion date: June 2013

Study information

• Verified date: October 2013
• Source: Kyowa Hakko Kirin Company, Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuralgia
• Neuralgia, Postherpetic
• Postherpetic Neuralgia

Intervention

Drug:
• KHK6188

• Placebo

Locations

Country	Name	City	State
Japan	Japan	Arakawa-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Hakko Kirin Company, Limited

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of pain intensity score		baseline and 2weeks	No
Secondary	Change of allodynia severity		baseline and 2 weeks	No
Secondary	Change of global impression		baseline and 2 weeks	No