Reduction of Postherpetic Neuralgia in Herpes Zoster

Sponsor

Center for Clinical Studies, Texas (Other)

Overall Status

Completed

CT.gov ID

NCT01250561

Collaborator

(none)

133

Enrollment

Location

67.9

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Herpes Zoster Post-herpetic Neuralgia	Drug: Gabapentin Drug: Valacyclovir	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

133 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Feb 1, 2002

Actual Primary Completion Date :

Oct 1, 2007

Actual Study Completion Date :

Oct 1, 2007

Outcome Measures

Primary Outcome Measures

Proportion of patients with zoster pain at 6 months []

Secondary Outcome Measures

Proportion of patients with zoster pain at 4 months []

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.