Reduction of Postherpetic Neuralgia in Herpes Zoster

This study has been completed.
Sponsor:
Information provided by:
Center for Clinical Studies, Texas
ClinicalTrials.gov Identifier:
NCT01250561
First received: November 29, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  Purpose

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 Intervention
Herpes Zoster
Post-herpetic Neuralgia
Drug: Gabapentin
Drug: Valacyclovir

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

Resource links provided by NLM:


Further study details as provided by Center for Clinical Studies, Texas:

Primary Outcome Measures:
  • Proportion of patients with zoster pain at 6 months

Secondary Outcome Measures:
  • Proportion of patients with zoster pain at 4 months

Enrollment: 133
Study Start Date: February 2002
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Gabapentin
    gabapentin 300mg/day, titrated up weekly to max tolerated dose or 3600mg/day (whichever is lower), for 4-9 weeks
    Drug: Valacyclovir
    valacyclovir 1000mg three-times daily x 7 days
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01250561

Locations
United States, Texas
Center for Clinical Studies
Houston, Texas, United States, 77030
Sponsors and Collaborators
Center for Clinical Studies, Texas
Investigators
Principal Investigator: Stephen Tyring, MD, PhD Center for Clinical Studies
  More Information

No publications provided by Center for Clinical Studies, Texas

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stephen Tyring, Center for Clinical Studies
ClinicalTrials.gov Identifier: NCT01250561     History of Changes
Other Study ID Numbers: CCS-06-001
Study First Received: November 29, 2010
Last Updated: November 29, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Center for Clinical Studies, Texas:
gabapentin
valacyclovir
phn
shingles

Additional relevant MeSH terms:
Neuralgia
Herpes Zoster
Neuralgia, Postherpetic
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Gabapentin
Valacyclovir
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents

ClinicalTrials.gov processed this record on September 16, 2014