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

Herpes Zoster Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02452112
• Other study ID #: LIG13-CN-301
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 20, 2015
• Last updated: November 10, 2017
• Start date: November 2, 2014
• Est. completion date: October 30, 2016

Study information

• Verified date: November 2017
• Source: Mundipharma (China) Pharmaceutical Co. Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 243
• Est. completion date: October 30, 2016
• Est. primary completion date: December 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Herpes Zoster
• Herpes Zoster Pain

Intervention

Drug:
• 5% Lidocaine patch
5% Lidocaine patch to be placed on the site of pain
• Placebo
Placebo patch to be placed on the site of pain

Locations

Country	Name	City	State
China	Air force general hospital	Beijing
China	Beijing friendship hospital	Beijing
China	Beijing university first hospital	Beijing
China	Beijing University People's Hospital	Beijing	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

Sponsors (1)

Lead Sponsor	Collaborator
Mundipharma (China) Pharmaceutical Co. Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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