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Efficacy and safety of gabapentin versus placebo to prevent the incidence of postherpetic neuralgia

Efficacy and safety of gabapentin versus placebo to prevent the incidence of PostHerpetic Neuralgia: a double-blinded clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN79871784
Enrollment
254
Registered
2013-05-02
Start date
2013-05-15
Completion date
Unknown
Last updated
2019-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postherpetic neuralgia Nervous System Diseases Postzoster neuralgia

Interventions

Antiviral therapy is first-line treatment and should be initiated within 72 hours of rash onset to increase the rate of healing and decrease pain, valacyclovir is also effective in the prevention of t
then, as necessary, mild opioids (codeine)
then strong opioids such as morphine, until the patient is free of pain. Gabapentin or placebo treatment: effective dose should be individualized according to patient response and tol

Sponsors

Primary Care Management of Mallorca (Gerencia de Atención Primaria de Mallorca) (Spain)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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)

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Prevalence of postherpetic neuralgia, assessed using the Visual Analog Scale (VAS >0) at 12 weeks

Secondary

MeasureTime frame
1. Prevalence of postherpetic neuralgiaa, assessed using the Visual Analog Scale (VAS >0) at 6 weeks 2. Percentage of patients with a reduction of at least 50% in the VAS scale

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 27, 2026