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Pregabalin Treatment and Prevention Post-herpetic Neuralgia

Sponsor
Second Affiliated Hospital of Guangzhou Medical University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03186443
Collaborator
China-Japan Friendship Hospital (Other), Nanjing PLA General Hospital (Other), Air Force Military Medical University, China (Other)
342
Enrollment
1
Location
2
Arms

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
342 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
control group is to oral gabapentin 0.4 tid； experiment group is to oral pregabalin 300mg q 12hcontrol group is to oral gabapentin 0.4 tid； experiment group is to oral pregabalin 300mg q 12h
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Prevention Effect of Pregabalin on Postherpetic Neuralgia: A Multicenter, Randomized, Double-blind, Controlled Trial
Anticipated Study Start Date :
Oct 1, 2017
Anticipated Primary Completion Date :
Oct 1, 2017
Anticipated Study Completion Date :
Oct 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: pregabalin

experiment group: pregabalin 300mg,q12h for 6 months

Drug: Pregabalin
Pregabalin was taken 300mg,q 12h for 6 month.
Other Names:
  • pregabalin tablet

    		•
    Experimental: gabapentin

    compared to pregabalin effect on herpetic neuralgia

    Drug: Gabapentin
    Gabapentin was taken 0.4, tid for 6 month.
    Other Names:
  • gabapentin tablet

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Brief Pain Inventory (BPI) [baseline and 8th month]

      quality of life was rated on Brief Pain Inventory

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National drug clinical trial fundation Guangzhou Guangdong China 510260

    Sponsors and Collaborators

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

    Investigators

    • Study Director: Li Wan, Ph.D.,M.D., The Second Affiliated Hospital,Guangzhou Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Second Affiliated Hospital of Guangzhou Medical University
    ClinicalTrials.gov Identifier:
    NCT03186443
    Other Study ID Numbers:
    • TT-01
    First Posted:
    Jun 14, 2017
    Last Update Posted:
    Jun 14, 2017
    Last Verified:
    Jun 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Second Affiliated Hospital of Guangzhou Medical University
    herpetic neuralgia
    post-herpetic neuralgia
    pregabalin
    Additional relevant MeSH terms:
    Neuralgia
    Pregabalin
    Gabapentin

    Study Results

    No Results Posted as of Jun 14, 2017