Reduction of Postherpetic Neuralgia in Herpes Zoster
This study has been completed.
Sponsor:
Center for Clinical Studies, Texas
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
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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:
MedlinePlus related topics:
Shingles
Drug Information available for:
Gabapentin
Valacyclovir
Valacyclovir hydrochloride
Gabapentin enacarbil
U.S. FDA Resources
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
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:
|
Herpes Zoster Neuralgia Neuralgia, Postherpetic Herpesviridae Infections DNA Virus Infections Virus Diseases Pain Neurologic Manifestations Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms 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 June 18, 2013