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A Study With Lidocaine 5% Medicated Plaster in Patients Suffering From Postherpetic Neuralgia

NCT03765697 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 259

Last updated 2023-09-13

No results posted yet for this study

Summary

This study was performed to evaluate the local and systemic safety profile and the analgesic efficacy of long-term treatment with lidocaine 5% medicated plaster (Lido-Patch).

The study was an open-label, multi-center, multiple-dose, Phase III study and comprised a main and an extension period. 161 participants who completed treatment in KF10004/01 (NCT03745404) and 98 newly recruited participants were enrolled.

Conditions

  • Post Herpetic Neuralgia

Interventions

DRUG

Lidocaine 5% medicated plaster

Topical application at the site of skin affected by painful PHN for up to 12 hours per day (plaster-free interval at least 12 hours).

Sponsors & Collaborators

  • Grünenthal GmbH

    lead INDUSTRY

Principal Investigators

  • Grünenthal Study Director · Grünenthal GmbH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-07-16
Primary Completion
2005-07-12
Completion
2009-02-12

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03765697 on ClinicalTrials.gov