A Comparative Study of KHK6188

NCT01544296 | Completed Phase 2

• 1 other identifier: 6188-004
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Postherpetic Neuralgia

Outcome Measures

Primary Outcomes (1)

• Change of pain intensity score

  baseline and 2weeks

Secondary Outcomes (2)

• Change of allodynia severity

  baseline and 2 weeks

• Change of global impression

  baseline and 2 weeks

Study Arms (3)

KHK6188, high dose

EXPERIMENTAL

Drug: KHK6188

KHK6188, low dose

EXPERIMENTAL

Drug: KHK6188

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

KHK6188 DRUG

KHK6188, high dose; KHK6188, low dose

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyowa Kirin Co., Ltd.: lead

Study Sites (1)

Japan

Arakawa-ku, Tokyo, Japan

Location

MeSH Terms

Conditions

Neuralgia, Postherpetic

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2012
• First Posted: March 5, 2012
• Study Start: February 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: October 10, 2013

Record last verified: 2013-10

Locations

JP (1)