Herpes ZosterNCT01250561
Reduction of Postherpetic Neuralgia in Herpes Zoster
A study testing Gabapentin and Valacyclovir in people with Herpes Zoster and Post-herpetic Neuralgia, run by Center for Clinical Studies, Texas at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Herpes Zoster, Post-herpetic Neuralgia
- What is being tested?
- Gabapentin and Valacyclovir
- How many people
- 133 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2002to Oct 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The addition of gabapentin therapy to standard antiviral treatment with valacyclovir in acute herpes zoster patients will decrease the incidence of post-herpetic neuralgia.
- Conditions
- Herpes Zoster, Post-herpetic Neuralgia
- Being tested
- Gabapentin, Valacyclovir
- Keywords
- gabapentin, valacyclovir, phn, shingles
- Medical subject headings
- Herpes Zoster, Neuralgia, Postherpetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
gabapentin 300mg/day, titrated up weekly to max tolerated dose or 3600mg/day (whichever is lower), for 4-9 weeks
ValacyclovirDrug
valacyclovir 1000mg three-times daily x 7 days
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with zoster pain at 6 months
Secondary outcomes (1)
Proportion of patients with zoster pain at 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2010 (estimated)
- Study startFeb 2002
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Herpes ZosterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Clinical Studies, Texas
- Sponsor type
- University, hospital or other
- Investigators
- Stephen Tyring, MD, PhD, Principal investigator, Center for Clinical Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01250561
- Sponsor's protocol ID
- CCS-06-001
- Status last verified
- Nov 2010
- First submitted
- 29 Nov 2010
- Last updated
- 1 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21482862
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Postherpetic Neuralgia in Herpes Zoster
- ClinicalTrials.gov ID
- NCT01250561
- Acronym / sponsor ID
- CCS-06-001
- Conditions
- Herpes Zoster, Post-herpetic Neuralgia
- Keywords
- gabapentin, valacyclovir, phn, shingles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Center for Clinical Studies, TexasUniversity, hospital or other
- Study start
- Feb 2002
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 1 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The addition of gabapentin therapy to standard antiviral treatment with valacyclovir in acute herpes zoster patients will decrease the incidence of post-herpetic neuralgia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gabapentingabapentin 300mg/day, titrated up weekly to max tolerated dose or 3600mg/day (whichever is lower), for 4-9 weeks | Drug | – |
| Valacyclovirvalacyclovir 1000mg three-times daily x 7 days | Drug | – |
Primary outcome
Proportion of patients with zoster pain at 6 months
1 secondary outcome
Proportion of patients with zoster pain at 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2010.
- Derived from this study: PubMed 21482862Lapolla 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Tyring, MD, PhD principal investigator
Center for Clinical Studies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gabapentin and Valacyclovir in people with Herpes Zoster and Post-herpetic Neuralgia, run by Center for Clinical Studies, Texas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with zoster pain at 6 months. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01250561, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2010.