Efficacy and Safety of 5% Lidocaine Patch With Placebo Patch in Subjects With Herpes Zoster Associated Pain
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
1 other identifier
interventional
243
1 country
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2014
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 2, 2014
CompletedFirst Submitted
Initial submission to the registry
May 20, 2015
CompletedFirst Posted
Study publicly available on registry
May 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2016
CompletedNovember 14, 2017
November 1, 2017
1.2 years
May 20, 2015
November 10, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Change of VAS score
Mean change in the mean pain VAS score
over 24 hour from baseline to the post-treatment over time during double-blind period
Study Arms (2)
Lidocaine
ACTIVE COMPARATORActive arm with administration of active 5% Lidocaine patch
Placebo
PLACEBO COMPARATORPlacebo arm with administration of placebo patch
Interventions
5% Lidocaine patch to be placed on the site of pain
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Beijing University People's Hospital
Beijing, Beijing Municipality, 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
Xi'an, China
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2015
First Posted
May 22, 2015
Study Start
November 2, 2014
Primary Completion
December 30, 2015
Study Completion
October 30, 2016
Last Updated
November 14, 2017
Record last verified: 2017-11