NCT02452112

CompletedPhase 2/3

Efficacy and Safety of 5% Lidocaine Patch With Placebo Patch...

Mundipharma (China) Pharmaceutical Co. Ltd Source

Mundipharma (China) Pharmaceutical Co. Ltd

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

LIG13-CN-301

Study Type

interventional

Actual enrollment (reported)

243

Locations

1 country

Sites

21

Timeline

Study Start

November 2, 2014

Actual (reported)

Primary Completion

December 30, 2015

Actual (reported)

Study Completion

October 30, 2016

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 243 participants
Study completion date: October 30, 2016
Actual (reported)
Listed locations: 1 countries · 21 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
November 2, 2014
Actual (reported)
First Submitted
May 20, 2015
Actual (reported)
First Posted
May 22, 2015
Actual (reported)
Primary Completion
December 30, 2015
Actual (reported)
Study Completion
October 30, 2016
Actual (reported)

Last Updated: November 14, 2017
Status Verified: November 2017
Last Update Submitted: November 10, 2017

Conditions

Herpes Zoster Pain

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 COMPARATOR

Active arm with administration of active 5% Lidocaine patch

Drug: 5% Lidocaine patch

Placebo

PLACEBO COMPARATOR

Placebo arm with administration of placebo patch

Drug: Placebo

Interventions

5% Lidocaine patchDrug

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

Also known as: Lignopad

Lidocaine

PlaceboDrug

Placebo patch to be placed on the site of pain

Placebo

Eligibility Criteria

Age18 Years - 85 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

Mundipharma (China) Pharmaceutical Co. Ltd
Industrylead

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

Enrollment

243 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2 3
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

Actual (reported)

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Phase 1Completed

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Comparative Pharmacokinetic Study of Lidocaine Patch 1.8% (ZTlido™) and Lidocaine Patch 5% (Lidoderm®) in Healthy Subjects

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Phase 4Unknown

NCT02088866

Commercial Lidocaine Patch as a Treatment for Ear-ringing

Early Phase 1Completed

NCT07344246

Efficacy and Safety of Intravenous Dexamethasone Palmitate Treatments in Acute and Subacute Herpes Zoster Pain

Not ApplicableNot Yet Recruiting

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.

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

Primary Completion

December 30, 2015

Actual (reported)

Study Completion

October 30, 2016

Actual (reported)

Last Updated

November 14, 2017

Record last verified: 2017-11

Source record

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Source: ClinicalTrials.gov.

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Registry identifier: NCT02452112
Data provider: ClinicalTrials.gov
Source updated: 2017-11-14
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:22:24 UTC

Locations

CN(21)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Lidocaine

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (21)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations