MedPath

A study to assess if gabapentine could prevent the postherpetic neuralgia in patient with Herpes zoster if treated the first 72 hour of the onset.

Phase 1
Conditions
Postherpetic Neuralgia
MedDRA version: 14.1Level: LLTClassification code 10054095Term: Neuropathic painSystem Organ Class: 100000004852
Therapeutic area: Diseases [C] - Virus Diseases [C02]
Registration Number
EUCTR2013-000521-31-ES
Lead Sponsor
Gerencia de Atención Primaria de Mallorca
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Patient aged >= 50 , diagnosed by uncomplicated herpes zoster with a < de 72h onset.

Visual analog scale of pain ? 4 (rated 0 to 10).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 54
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

Current or anticipated treatment with gabapentine or triciclys antidepresants

Patients diagnosed of hepatic insufficiency

Patients with a a history of intolerance of hipersensitivity to gabapentin or excipients.

Patients with impaired renal function (Clcr <79ml/min)

Patients with evidence of cutaneous, ocular or visceral disemination of herpes zoster infection (cutaneous disemination is defined as > 20 discrete lesion outside adjacent dermatomes) evidencia de diseminación cutánea o visceral del HZ (más de 20 lesiones fuera del
dermatoma adyacente)

Patients who have received inmunosupresive therapy in the last 3 months or inmunomodulatory medication (including interferon) within the previous 4 weeks
Patient diagnosed of inmunodeficiency

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath