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CompletedNCT02452112Updated Nov 14, 2017

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

A Phase 2/3 interventional study of 5% Lidocaine patch and Placebo in Herpes Zoster Pain, sponsored by Mundipharma (China) Pharmaceutical Co. Ltd. Completed at 21 sites in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2017-11-14.

Sponsored by Mundipharma (China) Pharmaceutical Co. Ltd · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Nov 2014, registered May 2015).
Phase
Phase 2/3
Study type
Interventional
Enrollment
243
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Herpes Zoster Pain

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03

In context

Herpes Zoster

360 studies on the registry are indexed under Herpes Zoster; 60 are open to participants now.

This study's enrollment of 243 is close to the median of 250 across 299 interventional studies indexed under Herpes Zoster.

Browse Herpes Zoster studies →

Lead sponsor

Mundipharma (China) Pharmaceutical Co. Ltd is the lead sponsor of 18 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
243 participants (actual)

Study arms

  • Active comparator
    Lidocaine

    Active arm with administration of active 5% Lidocaine patch

    Drug: 5% Lidocaine patch

  • Placebo comparator
    Placebo

    Placebo arm with administration of placebo patch

    Drug: Placebo

Interventions

  • Drug5% Lidocaine patch

    5% Lidocaine patch to be placed on the site of pain

    Also known as: Lignopad

  • DrugPlacebo

    Placebo patch to be placed on the site of pain

06

What researchers measure

Primary outcomes

  1. Change of VAS score

    Mean change in the mean pain VAS score

    Time frame: over 24 hour from baseline to the post-treatment over time during double-blind period

07

Study locations

21 sites
  • Beijing University People's Hospital
    Beijing, Beijing 100044, China
  • 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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 14, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02452112
Lead sponsor
Mundipharma (China) Pharmaceutical Co. Ltd
Responsible party
Sponsor
First posted
May 22, 2015
Start date
Nov 2, 2014
Primary completion
Dec 30, 2015
Completion
Oct 30, 2016
Last update
Nov 14, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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