Pregabalin Treatment and Prevention Post-herpetic Neuralgia

Second Affiliated Hospital of Guangzhou Medical University

Status and phase: Unknown; Phase 3

Conditions: Herpetic Neuralgia

Treatments: Drug: Pregabalin; Drug: Gabapentin

Study type: Interventional

Funder types: Other

Identifiers

NCT03186443

TT-01

Details and patient eligibility

About

Pregabalin is effective on herpetic neuralgia, but whether can prevention post-herpetic neuralgia still need to confirm.

Full description

Pregabalin has been recommended as the first-line drug for post-herpetic neuralgia (PHN) therapy currently due to its efficacy and safety. However,there was no valuable report at present on the clinical efficacy of pregabalin for acute and subacute herpetic neuralgia (SHN), expect for a smaller study which included 29 outpatients who had acute zoster pain for a period of 7-1 4 days. And it is not clear whether early application of pregabalin can reduce the incidence of PHN.

Therefore, this study was rational designed to evaluate the efficacy and safety of pregabalin in the treatment of herpetic neuralgia，and follow-up to the 8 months, evaluation whether impacting the accidence of PHN.

It is the first time in the international that treating acute herpetic neuralgia (AHN) and SHN with pregabalin as a large sample size clinical trial. The results of this study will be great significance for guiding the clinical medication.

Enrollment: 342 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Pain occurs within 90 days of rash onset
2. Numerical rating scale (NRS) greater than 50 mm

Exclusion criteria

1. Patient with nervous system disorders which impair completing the pain diaries
2. Patient with history of illicit drug or alcohol abuse within the last 2 years

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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342 participants in 2 patient groups

pregabalin

Active Comparator group

Description:

experiment group: pregabalin 300mg,q12h for 6 months

Treatment:

Drug: Pregabalin

gabapentin

Experimental group

Description:

compared to pregabalin effect on herpetic neuralgia

Treatment:

Drug: Gabapentin