Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
133 participants
INTERVENTIONAL
2002-02-28
2007-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Center for Clinical Studies, Texas
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Center for Clinical Studies
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Stephen Tyring, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Center for Clinical Studies
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Center for Clinical Studies
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CCS-06-001
Identifier Type: -
Identifier Source: org_study_id