drugset / Trial / NCT03765697
A Study With Lidocaine 5% Medicated Plaster in Patients Suffering From Postherpetic Neuralgia
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2003-07-16
- Primary completion
- 2005-07-12
- Completion
- 2009-02-12
Publications
- Results Hans G, Sabatowski R, Binder A, Boesl I, Rogers P, Baron R. Efficacy and tolerability of a 5% lidocaine medicated plaster for the topical treatment of post-herpetic neuralgia: results of a long-term study. Curr Med Res Opin. 2009 May;25(5):1295-305. doi: 10.1185/03007990902901368.
- Results Sabatowski R, Hans G, Tacken I, Kapanadze S, Buchheister B, Baron R. Safety and efficacy outcomes of long-term treatment up to 4 years with 5% lidocaine medicated plaster in patients with post-herpetic neuralgia. Curr Med Res Opin. 2012 Aug;28(8):1337-46. doi: 10.1185/03007995.2012.707977. Epub 2012 Jul 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lidocaine | Other / unclassified | 700 mg | Topical |