Pregabalin Treatment and Prevention Post-herpetic Neuralgia

Phase 3

• Conditions: Herpetic Neuralgia
• Interventions: Drug: Pregabalin; Drug: Gabapentin

• Registration Number: NCT03186443
• Lead Sponsor: Second Affiliated Hospital of Guangzhou Medical University

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.

Study Timeline

• Status Verified: 2017-06
• Study First Submitted: 2017-06-07
• Study First Submitted QC: 2017-06-13
• Last Update Submitted: 2017-06-13
• Study First Posted: 2017-06-14
• Last Update Posted: 2017-06-14
• Study Start: 2017-10-01
• Primary Completion: 2017-10-01
• Study Completion: 2017-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 342

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pregabalin	Pregabalin	experiment group: pregabalin 300mg,q12h for 6 months
gabapentin	Gabapentin	compared to pregabalin effect on herpetic neuralgia

Primary Outcome Measures

Name	Time	Method
the changes of numerical rating scale (NRS)	from the date of start to 8 month	Pain intensity was rated on an 1 1-point numerical rating scale

Secondary Outcome Measures

Name	Time	Method
Brief Pain Inventory (BPI)	baseline and 8th month	quality of life was rated on Brief Pain Inventory

Trial Locations

Locations (1)

National drug clinical trial fundation; 🇨🇳 Guangzhou, Guangdong, China