Clinical trial NCT02452112: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Herpes Zoster Pain
Lead sponsor: Mundipharma (China) Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2015-05-22
Enrollment: 243
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change of VAS score
timeFrame: over 24 hour from baseline to the post-treatment over time during double-blind period
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Air force general hospital
city: Beijing
country: China
facility: Beijing friendship hospital
city: Beijing
country: China
facility: Beijing university first hospital
city: Beijing
country: China
facility: Beijing university third hospital
city: Changchun
country: China
facility: The first affiliated hospital of Jilin university
city: Changsha
country: China
facility: Xiangya hospital central south university
city: Chengdu
country: China
facility: South West Hospital
city: Chongqing
country: China
facility: First affiliated hospital of Chongqing medical university
city: Dalian
country: China
facility: The first affiliated hospital of Dalian university
city: Guangzhou
country: China
facility: Guangzhou general hospital
city: Hangzhou
country: China
facility: The first affiliated hospital of Zhejiang university
city: Jinan
country: China
facility: Shandong dermatology hospital
city: Kunming
country: China
facility: The second affiliated hospital of Kunming medical college
city: Nanjing
country: China
facility: China dermatology research center
city: Shanghai
country: China
facility: Shanghai Huashan hospital
city: Shanghai
country: China
facility: Shanghai Ruijin Hospital
city: Shenyang
country: China
facility: Shengjing Hospital
city: Shijiazhuang
country: China
facility: The fourth affiliated hospital of Hebei medical university
city: Tianjin
country: China
facility: General hospital of Tianjin medical university
city: Xian
country: China
facility: Xijing Hospital
Study officials:
References: