Pregabalin Treatment and Prevention Post-herpetic Neuralgia

Herpetic Neuralgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03186443
• Other study ID #: TT-01
• Status: Not yet recruiting
• Phase: Phase 3
• First received: June 7, 2017
• Last updated: June 13, 2017
• Start date: October 1, 2017
• Est. completion date: October 1, 2017

Study information

• Verified date: June 2017
• Source: Second Affiliated Hospital of Guangzhou Medical University
• Contact: Li Wan, Ph.D.,M.D.
• Phone: 18122256632
• Email: wanli5000cn[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 342
• Est. completion date: October 1, 2017
• Est. primary completion date: October 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Herpetic Neuralgia
• Neuralgia
• Neuralgia, Postherpetic

Intervention

Drug:
• Pregabalin
Pregabalin was taken 300mg,q 12h for 6 month.
• Gabapentin
Gabapentin was taken 0.4, tid for 6 month.

Locations

Country	Name	City	State
China	National drug clinical trial fundation	Guangzhou	Guangdong

Sponsors (4)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Guangzhou Medical University	China-Japan Friendship Hospital, Fourth Military Medical University, Nanjing PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the changes of numerical rating scale (NRS)	Pain intensity was rated on an 1 1-point numerical rating scale	from the date of start to 8 month
Secondary	Brief Pain Inventory (BPI)	quality of life was rated on Brief Pain Inventory	baseline and 8th month