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Completed

NCT Number: NCT02452112

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

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.

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Key information

Conditions

Herpes Zoster Pain

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Beijing University People's Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

5% Lidocaine Patch

Drug

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

Other names: Lignopad

Placebo

Drug

Placebo patch to be placed on the site of pain

Primary outcomes

  1. Change of VAS score

    Time frame: over 24 hour from baseline to the post-treatment over time during double-blind period

    Mean change in the mean pain VAS score

Sponsors and collaborators

Lead sponsor

Mundipharma (China) Pharmaceutical Co. Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
May 22, 2015
Registry last updated
Nov 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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