Herpes Zoster Clinical Trial
The addition of gabapentin therapy to standard antiviral treatment with valacyclovir in acute herpes zoster patients will decrease the incidence of post-herpetic neuralgia.
Status | Completed |
Enrollment | 133 |
Est. completion date | October 2007 |
Est. primary completion date | October 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 50 Years and older |
Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Center for Clinical Studies | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Center for Clinical Studies, Texas |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients with zoster pain at 6 months | |||
Secondary | Proportion of patients with zoster pain at 4 months |
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