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
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