NCT03765697

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

An Open-label, Multicenter, Multiple-dose, Phase III Study With Lidocaine 5% Medicated Plaster in Patients Suffering From Postherpetic Neuralgia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 259 (actual)
• Sponsor: Grünenthal GmbH · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The main period was performed in 34 sites in 12 European countries (259 participants). Treatment duration was up to 12 months. All participants applied lidocaine 5% medicated plaster (containing 700 mg lidocaine per plaster) topically at the site of the skin affected by painful PHN. Depending on the size of the affected skin area, up-to 3 plasters were simultaneously applied for up to 12 hours per day (with a plaster-free interval of at least 12 hours). Study objectives of the main period were to evaluate the local and systemic safety profile and the analgesic efficacy of lidocaine 5% medicated plaster, and to evaluate the pharmacokinetics of lidocaine and its metabolite 2,6-xylidine in the target population after multiple administrations of lidocaine 5% medicated plaster by means of population kinetics. The study results were planned to be evaluated descriptively. 102 participants who were satisfied with the treatment in the main study period entered the open-label extension period with continued treatment. 27 sites in 12 countries participated in the extension period. Enrollment in the extension period coincided with last visit of the main period of the study. Treatment duration was up to 4.4 years in the extension period. The objective of the extension period was to evaluate the long-term local and systemic safety profile and the long-term analgesic efficacy of treatment with lidocaine 5% medicated plaster in the subpopulation who had completed 12 months of treatment in the open-label main study period.

Conditions

• Post Herpetic Neuralgia

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2003-07-16
• Primary completion: 2005-07-12
• Completion: 2009-02-12
• First posted: 2018-12-05
• Last updated: 2023-09-13