Pregabalin Treatment and Prevention Post-herpetic Neuralgia

NCT03186443 | Unknown Phase 3 DMC FDA Drug

• 1 other identifier: TT-01
• Study Type: interventional
• Target: 342
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Herpetic Neuralgia

Keywords

herpetic neuralgia; post-herpetic neuralgia; pregabalin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Brief Pain Inventory (BPI)

  baseline and 8th month

Study Arms (2)

pregabalin

ACTIVE COMPARATOR

experiment group: pregabalin 300mg,q12h for 6 months

Drug: Pregabalin

gabapentin

EXPERIMENTAL

compared to pregabalin effect on herpetic neuralgia

Drug: Gabapentin

Interventions

Pregabalin DRUG

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

Also known as: pregabalin tablet

pregabalin

Gabapentin DRUG

Gabapentin was taken 0.4, tid for 6 month.

Also known as: gabapentin tablet

gabapentin

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

National drug clinical trial fundation

Guangzhou, Guangdong, 510260, China

Location

MeSH Terms

Conditions

Neuralgia, Postherpetic

Interventions

Pregabalin; Gabapentin

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Amines; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Li Wan, Ph.D.,M.D.

  The Second Affiliated Hospital, Guangzhou Medical University

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

18122256632; wanli5000cn@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: June 7, 2017
• First Posted: June 14, 2017
• Study Start: October 1, 2017
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: June 14, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)