- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03186443
Pregabalin Treatment and Prevention Post-herpetic Neuralgia
Prevention Effect of Pregabalin on Postherpetic Neuralgia: A Multicenter, Randomized, Double-blind, Controlled Trial
Study Overview
Status
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
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Li Wan, Ph.D.,M.D.
- Phone Number: 18122256632
- Email: wanli5000cn@163.com
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510260
- National drug clinical trial fundation
-
Contact:
- Chu-Yan Lin, M.D.
-
Principal Investigator:
- Li Wan, Ph.D.,M.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
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
|
Pregabalin was taken 300mg,q 12h for 6 month.
Other Names:
|
Experimental: gabapentin
compared to pregabalin effect on herpetic neuralgia
|
Gabapentin was taken 0.4, tid for 6 month.
Other Names:
|
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
Collaborators
Investigators
- Study Director: Li Wan, Ph.D.,M.D., The Second Affiliated Hospital,Guangzhou Medical University
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Neuralgia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- Anti-Anxiety Agents
- Anticonvulsants
- Antimanic Agents
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Gabapentin
- Pregabalin
Other Study ID Numbers
- TT-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Herpetic Neuralgia
-
Pfizer's Upjohn has merged with Mylan to form Viatris...CompletedPost Herpetic NeuralgiaUnited States, Colombia, South Africa, Hong Kong, Ukraine, Bulgaria, Croatia, India, Sweden, Czechia, Denmark, Germany, Poland, Russian Federation, Serbia, Slovakia, Taiwan
-
Bial - Portela C S.A.Terminated
-
Odense University HospitalCompletedPost Herpetic NeuralgiaDenmark
-
DepomedCompletedPost Herpetic NeuralgiaUnited States
-
Grünenthal GmbHCompletedPost Herpetic Neuralgia
-
Novartis PharmaceuticalsTerminatedPost-herpetic NeuralgiaAustralia, Taiwan, Germany, France, Portugal, Czechia, United Kingdom, Hungary, Spain, Slovakia, Japan, Canada, Denmark, Norway, Austria, Belgium, Poland, Italy, Korea, Republic of
-
Convergence PharmaceuticalsCompletedPost-herpetic NeuralgiaSouth Africa
-
University of Sao PauloCompletedPost-herpetic Neuralgia
-
NeurAxon Inc.CompletedPost Herpetic NeuralgiaUnited States, Canada
-
Bristol-Myers SquibbCompleted
Clinical Trials on Pregabalin
-
Pfizer's Upjohn has merged with Mylan to form Viatris...Completed
-
AstraZenecaCompletedDiabetic Neuropathy, Painful; Diabetic NeuropathiesUnited States
-
Jiangsu HengRui Medicine Co., Ltd.UnknownPostherpetic NeuralgiaChina
-
Hamilton Health Sciences CorporationMcMaster UniversityTerminated
-
EMSRecruitingNeuropathic PainBrazil
-
Janssen-Cilag Ltd.Completed
-
The First Hospital of Jilin UniversityCompletedPain, Postoperative | Arthroplasty, Replacement, Knee | Arthroplasty, Replacement, HipChina
-
Pfizer's Upjohn has merged with Mylan to form Viatris...Completed
-
University of British ColumbiaJuvenile Diabetes Research FoundationUnknown
-
Ziauddin UniversityCompletedPain, Nerve | Prolapsed Intervertebral DiscPakistan