CClinicalTrials.gg
Status unknownNCT03186443Updated Jun 14, 2017

Pregabalin Treatment and Prevention Post-herpetic Neuralgia

A Phase 3 interventional study of Pregabalin and Gabapentin in Herpetic Neuralgia, sponsored by Second Affiliated Hospital of Guangzhou Medical University. Status unknown at 1 site in China. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2017-06-14.

Sponsored by Second Affiliated Hospital of Guangzhou Medical University · Phase 3, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jun 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
342
Allocation
Randomized
Ages
50 Years to 85 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Herpetic Neuralgia

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Keywords

  • herpetic neuralgia
  • post-herpetic neuralgia
  • pregabalin
03

In context

Neuralgia

1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.

This study's planned enrollment of 342 is above the median of 52 across 973 interventional studies indexed under Neuralgia.

Browse Neuralgia studies →

Lead sponsor

Second Affiliated Hospital of Guangzhou Medical University is the lead sponsor of 69 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
342 participants (estimated)

Study arms

  • Active comparator
    pregabalin

    experiment group: pregabalin 300mg,q12h for 6 months

    Drug: Pregabalin

  • Experimental
    gabapentin

    compared to pregabalin effect on herpetic neuralgia

    Drug: Gabapentin

Interventions

  • DrugPregabalin

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

    Also known as: pregabalin tablet

  • DrugGabapentin

    Gabapentin was taken 0.4, tid for 6 month.

    Also known as: gabapentin tablet

06

What researchers measure

Primary outcomes

  1. the changes of numerical rating scale (NRS)

    Pain intensity was rated on an 1 1-point numerical rating scale

    Time frame: from the date of start to 8 month

Secondary outcomes

  1. Brief Pain Inventory (BPI)

    quality of life was rated on Brief Pain Inventory

    Time frame: baseline and 8th month

07

Study locations

1 site
  • National drug clinical trial fundation
    Guangzhou, Guangdong 510260, China
    • Chu-Yan Lin, M.D. · Contact
    • Li Wan, Ph.D.,M.D. · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03186443
Lead sponsor
Second Affiliated Hospital of Guangzhou Medical University
Collaborators
China-Japan Friendship Hospital, Nanjing PLA General Hospital, Air Force Military Medical University, China
Responsible party
Sponsor
First posted
Jun 14, 2017
Start date
Oct 1, 2017 (estimated)
Primary completion
Oct 1, 2017 (estimated)
Completion
Oct 1, 2017 (estimated)
Last update
Jun 14, 2017

Study contacts

Li Wan, Ph.D.,M.D.
Contact
wanli5000cn@163.com
18122256632
Li Wan, Ph.D.,M.D.
study director · The Second Affiliated Hospital, Guangzhou Medical University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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