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

Last updated: September 12, 2023
Sponsor: Grünenthal GmbH
Overall Status: Completed

Phase

3

Condition

Pain (Pediatric)

Pain

Treatment

Lidocaine 5% medicated Plaster

Placebo Plaster

Clinical Study ID

NCT03745404
KF10004/01
  • Ages > 50
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria for the Run-in Phase:

  • Adult participants, male and female, with a minimum age of 50 years at screening.
  • Participants who had postherpetic neuralgia (PHN) for at least 3 months after healingof a herpes zoster skin rash.
  • Pain score of at least 4, based on an 11-point numerical rating scale (NRS) (scale of 0-10), at the screening and enrolment visit. The pain assessment is the participant'srecall of the pain intensity since the previous week.
  • Written informed consent given. Randomization Criteria:
  • Participants must be regularly (minimum every second day) using the Lido-Patch forcontrol of pain in the last 4 weeks of the run-in phase. The participant must wait forpain to increase before applying a new patch.
  • The participants' average daily pain intensity (with patch on) must be 7 or less on an 11-point NRS (scale of 0-10), and must increase during the phases when a patch is notworn, during Week 8 of the Run-in Phase.
  • Before randomization, the participant must have an average relief with Lido-Patch of "moderate" or better, on a 6-item scale (worse, no pain relief, slight, moderate, alot, complete) during Week 8 of the Run-in Phase.

Exclusion

Exclusion Criteria:

  • Participation in another study of investigational drugs or devices parallel to, orless than 30 days before screening, or previous participation in this study.
  • Known to or suspected of not being able to comply with the study protocol.
  • Any clinically significant condition that would, in the investigator's opinion,preclude study participation for instance alcohol, medication or drug dependency,neurotic personality, psychiatric illness, epilepsy or suicide risk.
  • Pregnancy or nursing mother.
  • Woman in childbearing age without satisfactory contraception.
  • Hypersensitivity to lidocaine or amide-type local anesthetic drugs.
  • Active herpes zoster lesion or dermatitis of any origin at the affected site with PHN.
  • Evidence of another cause for pain in the area affected by herpes zoster in additionto PHN, such as lumbar radiculopathy, surgery or trauma, if this could confoundassessment or self-evaluation of the pain due to post herpetic neuralgia.
  • Participants who had neurological ablation by block or neurosurgical intervention forcontrol of pain in PHN.
  • Participants using topically applied analgesic compounds on the PHN affected area.
  • Presence of other severe pain that could confound assessment or self-evaluation of thepain due to PHN.
  • Participants with severe hepatic disorder and/or alanine or aspartate aminotransferaseequal to or above 3-fold the upper limit of normal (ULN).
  • Participants with severe renal disorder and/or increased serum creatinine equal to orabove 1.5-fold the upper limit of normal (ULN).
  • Participants who are undergoing active treatment for cancer, are known to be infectedwith the human immunodeficiency virus (HIV), or being acutely and intensivelyimmunosuppressed following transplantation.

Study Design

Total Participants: 265
Treatment Group(s): 2
Primary Treatment: Lidocaine 5% medicated Plaster
Phase: 3
Study Start date:
April 29, 2003
Estimated Completion Date:
June 30, 2004

Study 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.