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

Phase 2

Completed

• Conditions: Herpes Zoster Pain
• Interventions: Drug: Placebo; Drug: 5% Lidocaine patch

• Registration Number: NCT02452112
• Lead Sponsor: Mundipharma (China) Pharmaceutical Co. Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-02
• Study First Submitted: 2015-05-20
• Study First Submitted QC: 2015-05-20
• Study First Posted: 2015-05-22
• Primary Completion: 2015-12-30
• Study Completion: 2016-10-30
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-10
• Last Update Posted: 2017-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 243

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo arm with administration of placebo patch
Lidocaine	5% Lidocaine patch	Active arm with administration of active 5% Lidocaine patch

Primary Outcome Measures

Name	Time	Method
Change of VAS score	over 24 hour from baseline to the post-treatment over time during double-blind period	Mean change in the mean pain VAS score

Trial Locations

Locations (21)

First affiliated hospital of Chongqing medical university; 🇨🇳 Chongqing, China

The first affiliated hospital of Dalian university; 🇨🇳 Dalian, China

General hospital of Tianjin medical university; 🇨🇳 Tianjin, China

Xijing Hospital; 🇨🇳 Xian, China

Shanghai Huashan hospital; 🇨🇳 Shanghai, China

Air force general hospital; 🇨🇳 Beijing, China

Beijing friendship hospital; 🇨🇳 Beijing, China

South West Hospital; 🇨🇳 Chengdu, China

Guangzhou general hospital; 🇨🇳 Guangzhou, China

Shandong dermatology hospital; 🇨🇳 Jinan, China

Shanghai Ruijin Hospital; 🇨🇳 Shanghai, China

Shengjing Hospital; 🇨🇳 Shenyang, China

The fourth affiliated hospital of Hebei medical university; 🇨🇳 Shijiazhuang, China

Beijing University People's Hospital; 🇨🇳 Beijing, Beijing, China

Beijing university first hospital; 🇨🇳 Beijing, China

Xiangya hospital central south university; 🇨🇳 Changsha, China

Beijing university third hospital; 🇨🇳 Beijing, China

The first affiliated hospital of Jilin university; 🇨🇳 Changchun, China

The first affiliated hospital of Zhejiang university; 🇨🇳 Hangzhou, China

China dermatology research center; 🇨🇳 Nanjing, China

The second affiliated hospital of Kunming medical college; 🇨🇳 Kunming, China