NCT03745404

A Study With Lido-Patch and Placebo Plaster in Patients Suffering From Postherpetic Neuralgia (PHN)

A Double-blind, Multicentre, Multiple-dose, Enriched Enrolment, Randomized-withdrawal, Parallel-group Phase III Study With Lido-Patch and Corresponding Placebo Plaster in Patients Suffering From Postherpetic Neuralgia (PHN)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 265 (actual)
• Sponsor: Grünenthal GmbH · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This study investigated the efficacy of the Lido-Patch (lidocaine 5% medicated plaster) in treatment of pain caused by PHN which is a neuropathic pain syndrome (nerve-related pain conditions) following an acute attack of herpes zoster (shingles).

Detailed description

Participants were treated up to 10 weeks in this study: an 8-week Run-in Phase of open-label treatment with Lido-Patch was followed by a 2-day to 14-day Double-blind Phase with Lido-Patch or Placebo Patch treatment. Only participants responding to open-label treatment with Lido-Patch were included in the Double-blind Phase. In a Follow-up Phase without treatment, the safety of participants was monitored for 1-2 weeks. Alternatively, patch application could be continued for up to 12 months in the clinical study KF10004/02.

Conditions

• Post Herpetic Neuralgia

Interventions

Type	Name	Description
DRUG	Lidocaine 5% medicated Plaster
DRUG	Placebo Plaster

Timeline

• Start date: 2003-04-29
• Primary completion: 2004-06-30
• Completion: 2004-06-30
• First posted: 2018-11-19
• Last updated: 2023-09-13