NCT02452112
Completed
Phase 2
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
Mundipharma (China) Pharmaceutical Co. Ltd21 sites in 1 country243 target enrollmentNovember 2, 2014
Overview
- Phase
- Phase 2
- Intervention
- 5% Lidocaine patch
- Conditions
- Herpes Zoster Pain
- Sponsor
- Mundipharma (China) Pharmaceutical Co. Ltd
- Enrollment
- 243
- Locations
- 21
- Primary Endpoint
- Change of VAS score
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Lidocaine
Active arm with administration of active 5% Lidocaine patch
Intervention: 5% Lidocaine patch
Placebo
Placebo arm with administration of placebo patch
Intervention: Placebo
Outcomes
Primary Outcomes
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
Study Sites (21)
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