- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02452112
Efficacy and Safety of 5% Lidocaine Patch With Placebo Patch in Subjects With Herpes Zoster Associated Pain
November 10, 2017 updated by: Mundipharma (China) Pharmaceutical Co. Ltd
An Open-Label, Single and Multiple-Dose, Two-Period, Consecutive Study in Healthy Chinese Subjects to Assess the Pharmacokinetic Profiles, Safety and Tolerability of Lidocaine Patch 5%.LIG13-CN-101 Study
This is a randomized, double-blind, placebo-controlled study designed to assess the efficacy and safety of 5% lidocaine patch, following placebo or active patch applications in placebo insensitive subjects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
243
Phase
- Phase 2
- 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
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Beijing, China
- Beijing Friendship Hospital
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Beijing, China
- Air force general hospital
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Beijing, China
- Beijing University First Hospital
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Beijing, China
- Beijing University Third Hospital
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Changchun, China
- The First Affiliated Hospital of Jilin University
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Changsha, China
- Xiangya Hospital Central South University
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Chengdu, China
- South West hospital
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Chongqing, China
- First Affiliated Hospital of Chongqing Medical University
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Dalian, China
- The first affiliated hospital of Dalian university
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Guangzhou, China
- Guangzhou general hospital
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Hangzhou, China
- The First Affiliated Hospital of Zhejiang University
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Jinan, China
- Shandong Dermatology Hospital
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Kunming, China
- The Second Affiliated Hospital of Kunming Medical College
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Nanjing, China
- China dermatology research center
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Shanghai, China
- Shanghai Ruijin Hospital
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Shanghai, China
- Shanghai Huashan Hospital
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Shenyang, China
- Shengjing Hospital
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Shijiazhuang, China
- The Fourth Affiliated Hospital of Hebei Medical University
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Tianjin, China
- General Hospital of Tianjin Medical University
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Xian, China
- Xijing Hospital
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Beijing
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Beijing, Beijing, China, 100044
- Beijing University People's Hospital
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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
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female subjects 18 to 85 years of age.
- Subjects must have herpes zoster associated pain present for ≥1 months after healing of the acute herpes zoster skin rash and not located on the face, scalp; the diagnosis will be based on physical examination and review of available medical records confirming an episode of herpes zoster.
- Herpes zoster associated pain must be of at least moderate severity, defined as the average pain level ≥40 mm on a 100 mm visual analog scale (VAS slide ruler)
Exclusion Criteria:
- Subjects with signs of cord or brainstem injury from herpes zoster.
- Presence of another pain problem of greater severity than their herpes zoster associated pain.
- Subjects who have undergone neurolytic nerve blocks or ablative neurosurgical procedures for control of herpes zoster associated pain
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Lidocaine
Active arm with administration of active 5% Lidocaine patch
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5% Lidocaine patch to be placed on the site of pain
Other Names:
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Placebo Comparator: Placebo
Placebo arm with administration of placebo patch
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Placebo patch to be placed on the site of pain
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of VAS score
Time Frame: over 24 hour from baseline to the post-treatment over time during double-blind period
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Mean change in the mean pain VAS score
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over 24 hour from baseline to the post-treatment over time during double-blind period
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Actual)
November 2, 2014
Primary Completion (Actual)
December 30, 2015
Study Completion (Actual)
October 30, 2016
Study Registration Dates
First Submitted
May 20, 2015
First Submitted That Met QC Criteria
May 20, 2015
First Posted (Estimate)
May 22, 2015
Study Record Updates
Last Update Posted (Actual)
November 14, 2017
Last Update Submitted That Met QC Criteria
November 10, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Virus Diseases
- Infections
- DNA Virus Infections
- Herpesviridae Infections
- Varicella Zoster Virus Infection
- Herpes Zoster
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
Other Study ID Numbers
- LIG13-CN-301
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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