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

Primary Purpose

Herpes Zoster Pain

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
5% Lidocaine patch
Placebo
Sponsored by
Mundipharma (China) Pharmaceutical Co. Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Herpes Zoster Pain

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing University People's Hospital
  • Air force general hospital
  • Beijing friendship hospital
  • Beijing university first hospital
  • Beijing university third hospital
  • The first affiliated hospital of Jilin university
  • Xiangya hospital central south university
  • South West Hospital
  • First affiliated hospital of Chongqing medical university
  • The first affiliated hospital of Dalian university
  • Guangzhou general hospital
  • The first affiliated hospital of Zhejiang university
  • Shandong dermatology hospital
  • The second affiliated hospital of Kunming medical college
  • China dermatology research center
  • Shanghai Huashan hospital
  • Shanghai Ruijin Hospital
  • Shengjing Hospital
  • The fourth affiliated hospital of Hebei medical university
  • General hospital of Tianjin medical university
  • Xijing Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Lidocaine

Placebo

Arm Description

Active arm with administration of active 5% Lidocaine patch

Placebo arm with administration of placebo patch

Outcomes

Primary Outcome Measures

Change of VAS score
Mean change in the mean pain VAS score

Secondary Outcome Measures

Full Information

First Posted
May 20, 2015
Last Updated
November 10, 2017
Sponsor
Mundipharma (China) Pharmaceutical Co. Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02452112
Brief Title
Efficacy and Safety of 5% Lidocaine Patch With Placebo Patch in Subjects With Herpes Zoster Associated Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
November 2, 2014 (Actual)
Primary Completion Date
December 30, 2015 (Actual)
Study Completion Date
October 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mundipharma (China) Pharmaceutical Co. Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Zoster Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
243 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine
Arm Type
Active Comparator
Arm Description
Active arm with administration of active 5% Lidocaine patch
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo arm with administration of placebo patch
Intervention Type
Drug
Intervention Name(s)
5% Lidocaine patch
Other Intervention Name(s)
Lignopad
Intervention Description
5% Lidocaine patch to be placed on the site of pain
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo patch to be placed on the site of pain
Primary Outcome Measure Information:
Title
Change of VAS score
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Beijing University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Air force general hospital
City
Beijing
Country
China
Facility Name
Beijing friendship hospital
City
Beijing
Country
China
Facility Name
Beijing university first hospital
City
Beijing
Country
China
Facility Name
Beijing university third hospital
City
Beijing
Country
China
Facility Name
The first affiliated hospital of Jilin university
City
Changchun
Country
China
Facility Name
Xiangya hospital central south university
City
Changsha
Country
China
Facility Name
South West Hospital
City
Chengdu
Country
China
Facility Name
First affiliated hospital of Chongqing medical university
City
Chongqing
Country
China
Facility Name
The first affiliated hospital of Dalian university
City
Dalian
Country
China
Facility Name
Guangzhou general hospital
City
Guangzhou
Country
China
Facility Name
The first affiliated hospital of Zhejiang university
City
Hangzhou
Country
China
Facility Name
Shandong dermatology hospital
City
Jinan
Country
China
Facility Name
The second affiliated hospital of Kunming medical college
City
Kunming
Country
China
Facility Name
China dermatology research center
City
Nanjing
Country
China
Facility Name
Shanghai Huashan hospital
City
Shanghai
Country
China
Facility Name
Shanghai Ruijin Hospital
City
Shanghai
Country
China
Facility Name
Shengjing Hospital
City
Shenyang
Country
China
Facility Name
The fourth affiliated hospital of Hebei medical university
City
Shijiazhuang
Country
China
Facility Name
General hospital of Tianjin medical university
City
Tianjin
Country
China
Facility Name
Xijing Hospital
City
Xian
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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