Clinical Trials Logo
  1. Home
  2. Post-Herpetic Neuralgia
  3. NCT03765697

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

Post Herpetic Neuralgia Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03765697
Study type Interventional
Source Grünenthal GmbH
Contact
Status Completed
Phase Phase 3
Start date July 16, 2003
Completion date February 12, 2009
View Details
See also
  Status Clinical Trial Phase
Completed NCT05496205 - A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers Phase 1
Completed NCT01426230 - Phase IV Study of FDA Approved, Once-Daily GRALISE™(Gabapentin) Tablets for the Treatment of Postherpetic Neuralgia N/A
Terminated NCT01124097 - Eslicarbazepine Acetate as Therapy in Post-Herpetic Neuralgia Phase 3
Completed NCT03974438 - Acupuncture as Treatment of Post-herpetic Neuralgia: A RCT A Double-blinded Randomized Clinical Trial. N/A
Recruiting NCT04144972 - Closed-Loop Deep Brain Stimulation for Refractory Chronic Pain N/A
Completed NCT03447756 - Titration Study of ABX-1431 Phase 1
Recruiting NCT06155487 - A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Oral Administration of AJH-2947 in Healthy Korean and/or Caucasian Adult Male Subjects Phase 1
Recruiting NCT06218784 - A MAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers and PHN Patients. Phase 1
Completed NCT03584061 - Treatment of Chronic Postherpetic Pain With Fat Grafting N/A
Completed NCT01270828 - Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Postherpetic Neuralgia Phase 3
Enrolling by invitation NCT06410222 - Predictive Models for the Treatment of Recurrent Herpes Zoster Neuralgia Following Spinal Cord Electrical Stimulation.
Recruiting NCT05754190 - Assessing Symptom and Mood Dynamics in Pain Using the Smartphone Application SOMA
Completed NCT00475904 - A Comparison of EpiCept™ NP-1 Topical Cream vs. Oral Gabapentin in Postherpetic Neuralgia (PHN) Phase 2
Not yet recruiting NCT06130514 - The Comparison of Sympathetic Blockade of Stellate Ganglion Block and Thoracic Sympathetic Ganglion Block N/A
Completed NCT01748877 - Efficacy, Tolerability, and Safety of NXN-462 in Patients With Post-Herpetic Neuralgia Phase 2
Active, not recruiting NCT06241820 - The Success of Lumbar Sympathetic Ganglion Block Using Lower Extremity Perfusion Index N/A
Completed NCT03745404 - A Study With Lido-Patch and Placebo Plaster in Patients Suffering From Postherpetic Neuralgia (PHN) Phase 3