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Pregabalin Treatment and Prevention Post-herpetic Neuralgia

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03186443
Enrollment
342
Registered
2017-06-14
Start date
2017-10-01
Completion date
2017-10-01
Last updated
2017-06-14

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

Conditions

Herpetic Neuralgia

Keywords

herpetic neuralgia, post-herpetic neuralgia, pregabalin

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.

Interventions

DRUGPregabalin

Pregabalin was taken 300mg,q 12h for 6 month.

DRUGGabapentin

Gabapentin was taken 0.4, tid for 6 month.

Sponsors

China-Japan Friendship Hospital
CollaboratorOTHER
Nanjing PLA General Hospital
CollaboratorOTHER
Air Force Military Medical University, China
CollaboratorOTHER
Second Affiliated Hospital of Guangzhou Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

control group is to oral gabapentin 0.4 tid; experiment group is to oral pregabalin 300mg q 12h

Eligibility

Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
the changes of numerical rating scale (NRS)from the date of start to 8 monthPain intensity was rated on an 1 1-point numerical rating scale

Secondary

MeasureTime frameDescription
Brief Pain Inventory (BPI)baseline and 8th monthquality of life was rated on Brief Pain Inventory

Countries

China

Contacts

Primary ContactLi Wan, Ph.D.,M.D.
wanli5000cn@163.com18122256632

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026