Pregabalin Treatment and Prevention Post-herpetic Neuralgia

Study Overview
=================
Brief Summary
-----------------
Pregabalin is effective on herpetic neuralgia, but whether can prevention post-herpetic neuralgia still need to confirm.

Detailed 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.

Official Title
-----------------
Prevention Effect of Pregabalin on Postherpetic Neuralgia: A Multicenter, Randomized, Double-blind, Controlled Trial

Conditions
-----------------
Herpetic Neuralgia

Intervention / Treatment
-----------------
* Drug: Pregabalin
* Drug: Gabapentin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pain occurs within 90 days of rash onset Numerical rating scale (NRS) greater than 50 mm Exclusion Criteria: Patient with nervous system disorders which impair completing the pain diaries Patient with history of illicit drug or alcohol abuse within the last 2 years

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: control group is to oral gabapentin 0.4 tid； experiment group is to oral pregabalin 300mg q 12h
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: pregabalin<br>experiment group: pregabalin 300mg,q12h for 6 months | Drug: Pregabalin<br>* Pregabalin was taken 300mg,q 12h for 6 month.<br>* Other names: pregabalin tablet;|
| Experimental: gabapentin<br>compared to pregabalin effect on herpetic neuralgia | Drug: Gabapentin<br>* Gabapentin was taken 0.4, tid for 6 month.<br>* Other names: gabapentin tablet;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the changes of numerical rating scale (NRS) | Pain intensity was rated on an 1 1-point numerical rating scale | from the date of start to 8 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Pain Inventory (BPI) | quality of life was rated on Brief Pain Inventory | baseline and 8th month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
herpetic neuralgia, post-herpetic neuralgia, pregabalin