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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01250561
Other study ID # CCS-06-001
Secondary ID
Status Completed
Phase N/A
First received November 29, 2010
Last updated November 29, 2010
Start date February 2002
Est. completion date October 2007

Study information

Verified date November 2010
Source Center for Clinical Studies, Texas
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Gabapentin
gabapentin 300mg/day, titrated up weekly to max tolerated dose or 3600mg/day (whichever is lower), for 4-9 weeks
Valacyclovir
valacyclovir 1000mg three-times daily x 7 days

Locations

Country Name City State
United States Center for Clinical Studies Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
Center for Clinical Studies, Texas

Country where clinical trial is conducted

United States, 

Outcome

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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