NCT01544296CompletedPhase 2
Phase II Study of KHK6188 (A Placebo-controlled, Double Blind, Crossover Study of KHK6188 in Postherpetic Neuralgia)
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Kyowa Kirin Co., Ltd.
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Change of pain intensity score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
KHK6188, high dose
Experimental
Intervention: KHK6188 (Drug)
KHK6188, low dose
Experimental
Intervention: KHK6188 (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change of pain intensity score
Time Frame: baseline and 2weeks
Secondary Outcomes
- Change of allodynia severity(baseline and 2 weeks)
- Change of global impression(baseline and 2 weeks)
Investigators
Study Sites (1)
Loading locations...
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