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

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Mundipharma

Status and phase

Completed
Phase 3
Phase 2

Conditions

Herpes Zoster Pain

Treatments

Drug: Placebo
Drug: 5% Lidocaine patch

Study type

Interventional

Funder types

Industry

Identifiers

NCT02452112
LIG13-CN-301

Details and patient eligibility

About

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.

Enrollment

243 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

243 participants in 2 patient groups, including a placebo group

Lidocaine
Active Comparator group
Description:
Active arm with administration of active 5% Lidocaine patch
Treatment:
Drug: 5% Lidocaine patch
Placebo
Placebo Comparator group
Description:
Placebo arm with administration of placebo patch
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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