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

NCT03745404 | Completed Phase 3

• 1 other identifier: KF10004/01
• Study Type: interventional
• Target: 265
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Post Herpetic Neuralgia

Keywords

Post herpetic neuralgia; Lidocaine; Herpes zoster

Outcome Measures

Primary Outcomes (1)

• Time-to-exit in Double-blind Phase Due to Lack of Efficacy

  The time to exit was defined as the number of days after randomization where worsening of the pain relief score by 2 or more categories on a 6-item pain relief scale (verbal rating scale, VRS) on 2 consecutive days in comparison to the average pain relief in Week 8 of the Run-in Phase was reported. The average pain relief in Week 8 of the enrichment phase was to be stated by the participant at the randomization visit. The VRS comprised the categories 1 = worse, 2 = no pain relief, 3 = slight, 4 = moderate, 5 = a lot, 6 = complete.

  From Day 1 until time to exit in Double-blind Phase (maximum Day 14)

Secondary Outcomes (8)

• Daily Pain Intensity: NRS

  From screening visit (Week -1) to end of Double-blind Phase visit (Week 10)

• Daily Pain Relief

  From screening visit (Week -1) to end of Double-blind Phase visit (Week 10)

• Weekly Average 24-hour Pain Intensity: NRS

  During Run-in Phase (visits after 1 and 4 weeks), after 8 weeks, and after 10 weeks (Double-blind Phase)

• Weekly Average Current Pain Intensity: NRS

  During Run-in Phase (visits after 1 and 4 weeks), after 8 weeks, and after 10 weeks (Double-blind Phase)

• Weekly Average Pain Relief: VRS

  During Run-in Phase (visits after 1 and 4 weeks), after 8 weeks, and after 10 weeks (Double-bind Phase)

Other Outcomes (5)

• Chronic Pain Sleep Inventory (CPSI)

  From screening at each visit up to the final visit (Week 10) [6 time points in total]

• Short Form McGill Pain Questionnaire (SF-MPQ)

  At screening visit (Week -1), randomization visit (Week 8), and final visit (Week 10)

• Clinical Global Impression of Change (CGIC)

  Withdrawal visit (end of Run-in Phase) or final visit (end of Double-blind Phase)

Study Arms (3)

Lido-Patch (Open-label Run-in Phase)

EXPERIMENTAL

All participants applied up to 3 Lido-Patches (lidocaine 5% medicated plaster) per day (depending on the size of PHN area). Patches were applied topically for up to 12 hours per day (patch free interval: at least 12 hours) at the site of skin affected by painful PHN.

Drug: Lidocaine 5% medicated Plaster

Lido-Patch (Double-blind Phase)

EXPERIMENTAL

Up to 3 patches (lidocaine 5% medicated plaster) per day (depending on the size of PHN area) were applied topically for up to 12 hours per day (patch free interval: at least 12 hours) at the site of skin affected by painful PHN.

Drug: Lidocaine 5% medicated Plaster

Placebo Patch (Double-blind Phase)

PLACEBO COMPARATOR

Up to 3 placebo plasters per day (depending on the size of PHN area) were applied topically for up to 12 hours per day (patch free interval: at least 12 hours) at the site of skin affected by painful PHN.

Drug: Placebo Plaster

Interventions

Lidocaine 5% medicated Plaster DRUG

Also known as: Versatis (Trade Mark), Lidoderm (Trade Mark), Neurodol Tissugel (Trade Mark)

Lido-Patch (Double-blind Phase); Lido-Patch (Open-label Run-in Phase)

Placebo Plaster DRUG

Placebo Patch (Double-blind Phase)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Grünenthal GmbH: lead

Related Publications (1)

• Binder A, Bruxelle J, Rogers P, Hans G, Bosl I, Baron R. Topical 5% lidocaine (lignocaine) medicated plaster treatment for post-herpetic neuralgia: results of a double-blind, placebo-controlled, multinational efficacy and safety trial. Clin Drug Investig. 2009;29(6):393-408. doi: 10.2165/00044011-200929060-00003.

  PMID: 19432499 RESULT

MeSH Terms

Conditions

Neuralgia, Postherpetic; Herpes Zoster

Interventions

Lidocaine; Lidoderm

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Grünenthal Study Director

  Grünenthal GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Open-label enriched enrolment followed by double-blind treatment for 2 weeks.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: An enriched enrolment, randomized-withdrawal, parallel-group design was applied. Only participants responding to open-label active treatment were included into the Double-blind Phase. The study comprised: * A non-controlled, open-label enrichment phase with Lido-Patch treatment (Run-in Phase). * A double-blind, randomized-withdrawal phase (Double-blind Phase). * Upon request of the participant, treatment could be continued in the clinical study KF10004/02. * A Follow-up Phase without treatment for participants not continuing in KF10004/02.

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: November 19, 2018
• Study Start: April 29, 2003
• Primary Completion: June 30, 2004
• Study Completion: June 30, 2004
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share