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

Sponsored by Grünenthal GmbH

About this trial

Last updated 2 years ago

Study ID

KF10004/01

Status

Completed

Type

Interventional

Phase

Phase 3

Placebo

No

Accepting

18-75 Years
50+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 21 years ago

What is this trial about?

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).

What are the Participation Requirements?

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
healing of 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's recall 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 for
control of pain in the last 4 weeks of the run-in phase. The participant must wait
for pain 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
not worn, 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, a
lot, complete) during Week 8 of the Run-in Phase.

Exclusion Criteria:

- Participation in another study of investigational drugs or devices parallel to, or
less 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 addition
to PHN, such as lumbar radiculopathy, surgery or trauma, if this could confound
assessment or self-evaluation of the pain due to post herpetic neuralgia.

- Participants who had neurological ablation by block or neurosurgical intervention
for control 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
the pain due to PHN.

- Participants with severe hepatic disorder and/or alanine or aspartate
aminotransferase equal to or above 3-fold the upper limit of normal (ULN).

- Participants with severe renal disorder and/or increased serum creatinine equal to
or above 1.5-fold the upper limit of normal (ULN).

- Participants who are undergoing active treatment for cancer, are known to be
infected with the human immunodeficiency virus (HIV), or being acutely and
intensively immunosuppressed following transplantation.