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Efficacy and Safety of 5% Lidocaine Patch With Placebo Patch in Subjects With Herpes Zoster Associated Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02452112
Recruitment Status : Completed
First Posted : May 22, 2015
Last Update Posted : November 14, 2017
Information provided by (Responsible Party):
Mundipharma (China) Pharmaceutical Co. Ltd

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Herpes Zoster Pain Drug: 5% Lidocaine patch Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 243 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 2, 2014
Actual Primary Completion Date : December 30, 2015
Actual Study Completion Date : October 30, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles

Arm Intervention/treatment
Active Comparator: Lidocaine
Active arm with administration of active 5% Lidocaine patch
Drug: 5% Lidocaine patch
5% Lidocaine patch to be placed on the site of pain
Other Name: Lignopad

Placebo Comparator: Placebo
Placebo arm with administration of placebo patch
Drug: Placebo
Placebo patch to be placed on the site of pain

Primary Outcome Measures :
  1. Change of VAS score [ Time Frame: over 24 hour from baseline to the post-treatment over time during double-blind period ]
    Mean change in the mean pain VAS score

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male or female subjects 18 to 85 years of age.
  2. 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.
  3. 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:

  1. Subjects with signs of cord or brainstem injury from herpes zoster.
  2. Presence of another pain problem of greater severity than their herpes zoster associated pain.
  3. Subjects who have undergone neurolytic nerve blocks or ablative neurosurgical procedures for control of herpes zoster associated pain

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02452112

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China, Beijing
Beijing University People's Hospital
Beijing, Beijing, China, 100044
Air force general hospital
Beijing, China
Beijing friendship hospital
Beijing, China
Beijing university first hospital
Beijing, China
Beijing university third hospital
Beijing, China
The first affiliated hospital of Jilin university
Changchun, China
Xiangya hospital central south university
Changsha, China
South West Hospital
Chengdu, China
First affiliated hospital of Chongqing medical university
Chongqing, China
The first affiliated hospital of Dalian university
Dalian, China
Guangzhou general hospital
Guangzhou, China
The first affiliated hospital of Zhejiang university
Hangzhou, China
Shandong dermatology hospital
Jinan, China
The second affiliated hospital of Kunming medical college
Kunming, China
China dermatology research center
Nanjing, China
Shanghai Huashan hospital
Shanghai, China
Shanghai Ruijin Hospital
Shanghai, China
Shengjing Hospital
Shenyang, China
The fourth affiliated hospital of Hebei medical university
Shijiazhuang, China
General hospital of Tianjin medical university
Tianjin, China
Xijing Hospital
Xian, China
Sponsors and Collaborators
Mundipharma (China) Pharmaceutical Co. Ltd

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Responsible Party: Mundipharma (China) Pharmaceutical Co. Ltd Identifier: NCT02452112     History of Changes
Other Study ID Numbers: LIG13-CN-301
First Posted: May 22, 2015    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017
Additional relevant MeSH terms:
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Herpes Zoster
Varicella Zoster Virus Infection
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action