Efficacy and safety of gabapentin versus placebo to prevent the incidence of postherpetic neuralgia
- Conditions
- Postherpetic neuralgiaPostzoster neuralgiaNervous System Diseases
- Registration Number
- ISRCTN79871784
- Lead Sponsor
- Primary Care Management of Mallorca (Gerencia de Atención Primaria de Mallorca) (Spain)
- Brief Summary
2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/28088231 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31166976 (added 06/06/2019)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 98
1. Patient aged 50 or above, either sex
2. Patient diagnosed or uncomplicated herpes zoster within 72 hours of onset of the rash in patients with acute herpes zoster and with moderate/severe pain (Analogic visual scale = 4)
1. Patients taking gabapentin
2. Patients diagnosed of severe hepatic impairment, hypersensitivity to gabapentin or excipients, acute renal failure or renal impairment (Clcr <79ml/min)
3. Patients with evidence of cutaneous or visceral dissemination of herpes zoster infection (cutaneous dissemination is defined as 20 discrete lesions outside adjacent dermatomes) or ocular dissemination
4. Immunocompromised state and/or interferon treatment in the last 4 weeks
5. Patient taking tricyclic antidepressants or corticoids in the inclusion or treatment period
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prevalence of postherpetic neuralgia, assessed using the Visual Analog Scale (VAS >0) at 12 weeks
- Secondary Outcome Measures
Name Time Method <br> 1. Prevalence of postherpetic neuralgiaa, assessed using the Visual Analog Scale (VAS >0) at 6 weeks<br> 2. Percentage of patients with a reduction of at least 50% in the VAS scale<br>