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Pregabalin Treatment and Prevention Post-herpetic Neuralgia

Primary Purpose

Herpetic Neuralgia

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Pregabalin

Gabapentin

About this trial

This is an interventional prevention trial for Herpetic Neuralgia focused on measuring herpetic neuralgia, post-herpetic neuralgia, pregabalin

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Pain occurs within 90 days of rash onset
Numerical rating scale (NRS) greater than 50 mm

Exclusion Criteria:

Patient with nervous system disorders which impair completing the pain diaries
Patient with history of illicit drug or alcohol abuse within the last 2 years

Sites / Locations

National drug clinical trial fundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

pregabalin

gabapentin

Arm Description

experiment group: pregabalin 300mg,q12h for 6 months

compared to pregabalin effect on herpetic neuralgia

Outcomes

Primary Outcome Measures

the changes of numerical rating scale (NRS)

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

Secondary Outcome Measures

Brief Pain Inventory (BPI)

quality of life was rated on Brief Pain Inventory

Full Information

NCT ID

NCT03186443

First Posted

June 7, 2017

Last Updated

June 13, 2017

Sponsor

Second Affiliated Hospital of Guangzhou Medical University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT03186443

Brief Title

Pregabalin Treatment and Prevention Post-herpetic Neuralgia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Unknown status

Study Start Date

October 1, 2017 (Anticipated)

Primary Completion Date

October 1, 2017 (Anticipated)

Study Completion Date

October 1, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Second Affiliated Hospital of Guangzhou Medical University

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Herpetic Neuralgia

Keywords

herpetic neuralgia, post-herpetic neuralgia, pregabalin

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Randomized

Enrollment

342 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

pregabalin

Arm Type

Active Comparator

Arm Description

experiment group: pregabalin 300mg,q12h for 6 months

Arm Title

gabapentin

Arm Type

Experimental

Arm Description

compared to pregabalin effect on herpetic neuralgia

Intervention Type

Drug

Intervention Name(s)

Pregabalin

Other Intervention Name(s)

pregabalin tablet

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Gabapentin

Other Intervention Name(s)

gabapentin tablet

Intervention Description

Gabapentin was taken 0.4, tid for 6 month.

Primary Outcome Measure Information:

Title

the changes of numerical rating scale (NRS)

Description

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

Time Frame

from the date of start to 8 month

Secondary Outcome Measure Information:

Title

Brief Pain Inventory (BPI)

Description

quality of life was rated on Brief Pain Inventory

Time Frame

baseline and 8th month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Pain occurs within 90 days of rash onset Numerical rating scale (NRS) greater than 50 mm Exclusion Criteria: Patient with nervous system disorders which impair completing the pain diaries Patient with history of illicit drug or alcohol abuse within the last 2 years

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Li Wan, Ph.D.,M.D.

Phone

18122256632

wanli5000cn@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Li Wan, Ph.D.,M.D.

Organizational Affiliation

The Second Affiliated Hospital,Guangzhou Medical University

Official's Role

Study Director

Facility Information:

Facility Name

National drug clinical trial fundation

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510260

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chu-Yan Lin, M.D.

First Name & Middle Initial & Last Name & Degree

Li Wan, Ph.D.,M.D.

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Pregabalin Treatment and Prevention Post-herpetic Neuralgia

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