Reduction of Postherpetic Neuralgia in Herpes Zoster

Herpes Zoster Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01250561
• Other study ID #: CCS-06-001
• 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

Related Conditions & MeSH terms

• Herpes Zoster
• Neuralgia
• Neuralgia, Postherpetic
• Post-herpetic Neuralgia

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