Herpes Zoster, Post-herpetic Neuralgia
Conditions
Keywords
gabapentin, valacyclovir, phn, shingles
Brief summary
The addition of gabapentin therapy to standard antiviral treatment with valacyclovir in acute herpes zoster patients will decrease the incidence of post-herpetic neuralgia.
Interventions
DRUGGabapentin
gabapentin 300mg/day, titrated up weekly to max tolerated dose or 3600mg/day (whichever is lower), for 4-9 weeks
DRUGValacyclovir
valacyclovir 1000mg three-times daily x 7 days
Sponsors
Center for Clinical Studies, Texas
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female patients of 50 years of age and older. * Patients with a clinical diagnosis of uncomplicated herpes zoster presenting within the first 72 hours of vesicles. * Patients who are willing and able to comply with the requirements of the study. * Patients who are willing and able to give written informed consent. * Average pain score pre-therapy greater or equal than 4 on 10-point Likert scale.
Exclusion criteria
* Sexually-active women of childbearing potential, including postmenopausal women less than 1 year since last menses, not employing adequate contraception (approved oral contraceptive, intrauterine device, barrier methods or total abstinence). * Pregnant females and nursing mothers. * Patients with immune dysfunction including congenital immune deficiency, active malignancy of any type, collagen vascular diseases, organ or bone marrow transplantations, known infection with HIV or severe atopic dermatitis. * Patients who have received cytotoxic drugs or immunosuppressive therapy (e.g., chronic systemic corticosteroids) within the previous 3 months. * Patients with evidence of cutaneous or visceral dissemination of herpes zoster infection (cutaneous dissemination is defined as \> 20 discrete lesions outside adjacent dermatomes). * Patients who have received systemic anti-VZV medications or immunomodulatory medications (including interferon) within the previous 4 weeks. * Patients currently receiving probenecid. * Patients with impaired renal function: calculated creatinine clearance of \<30 mL/min using Cockcroft and Gault formula. * Patients with abnormal liver function (alanine transaminase (ALT) or aspartate;transaminase (AST) levels greater than five times the upper limit of the normal range). * Patients with a history of intolerance or hypersensitivity to acyclovir, penciclovir, valacyclovir, famciclovir or gabapentin. * Patients currently receiving therapy with gabapentin or tricyclic antidepressants. * Patients with clinical evidence of ocular involvement of herpes zoster. Patients with herpes zoster of the ophthalmic branch of the trigeminal nerve without evidence of ocular involvement will be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with zoster pain at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with zoster pain at 4 months | — |
Countries
United States
Outcome results
None listed