Pregabalin Treatment and Prevention Post-herpetic Neuralgia

June 13, 2017 updated by: Second Affiliated Hospital of Guangzhou Medical University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

342

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510260
        • National drug clinical trial fundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the changes of numerical rating scale (NRS)
Time Frame: from the date of start to 8 month
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)
Time Frame: baseline and 8th month
quality of life was rated on Brief Pain Inventory
baseline and 8th month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Guangzhou Medical University

Collaborators

China-Japan Friendship Hospital
Air Force Military Medical University, China
Nanjing PLA General Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2017

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

June 7, 2017

First Submitted That Met QC Criteria

June 13, 2017

First Posted (Actual)

June 14, 2017

Study Record Updates

Last Update Posted (Actual)

June 14, 2017

Last Update Submitted That Met QC Criteria

June 13, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TT-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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