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

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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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