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Reduction of Postherpetic Neuralgia in Herpes Zoster

Primary Purpose

Herpes Zoster, Post-herpetic Neuralgia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gabapentin
Valacyclovir
Sponsored by
Center for Clinical Studies, Texas
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Herpes Zoster focused on measuring gabapentin, valacyclovir, phn, shingles

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Center for Clinical Studies

Outcomes

Primary Outcome Measures

Proportion of patients with zoster pain at 6 months

Secondary Outcome Measures

Proportion of patients with zoster pain at 4 months

Full Information

First Posted
November 29, 2010
Last Updated
November 29, 2010
Sponsor
Center for Clinical Studies, Texas
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1. Study Identification

Unique Protocol Identification Number
NCT01250561
Brief Title
Reduction of Postherpetic Neuralgia in Herpes Zoster
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Center for Clinical Studies, Texas

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Zoster, Post-herpetic Neuralgia
Keywords
gabapentin, valacyclovir, phn, shingles

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
133 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Description
gabapentin 300mg/day, titrated up weekly to max tolerated dose or 3600mg/day (whichever is lower), for 4-9 weeks
Intervention Type
Drug
Intervention Name(s)
Valacyclovir
Intervention Description
valacyclovir 1000mg three-times daily x 7 days
Primary Outcome Measure Information:
Title
Proportion of patients with zoster pain at 6 months
Secondary Outcome Measure Information:
Title
Proportion of patients with zoster pain at 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Tyring, MD, PhD
Organizational Affiliation
Center for Clinical Studies
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Clinical Studies
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21482862
Citation
Lapolla W, Digiorgio C, Haitz K, Magel G, Mendoza N, Grady J, Lu W, Tyring S. Incidence of postherpetic neuralgia after combination treatment with gabapentin and valacyclovir in patients with acute herpes zoster: open-label study. Arch Dermatol. 2011 Aug;147(8):901-7. doi: 10.1001/archdermatol.2011.81. Epub 2011 Apr 11.
Results Reference
derived

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Reduction of Postherpetic Neuralgia in Herpes Zoster

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