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

NCT03765697 | Completed Phase 3

• 1 other identifier: KF10004/02
• Study Type: interventional
• Target: 259
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Post Herpetic Neuralgia

Keywords

post-herpetic neuralgia; lidocaine

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment emergent adverse events (main study period)

  Treatment emergent adverse events (TEAEs) were continually monitored through the main period of the study (12 months). Incidences were calculated based on all events reported up to 12 months. No primary endpoint was defined for this study.

  From first plaster application up to 12 months

Secondary Outcomes (4)

• Pain relief (main study period): verbal rating scale

  After 1, 6, 12, 18, 26, 34, 42, and 52 weeks (or early withdrawal)

• Pain intensity (main study period): Numeric Rating Scale

  At screening/enrollment and after 1, 6, 12, 18, 26, 34, 42, and 52 weeks (or early withdrawal)

• Pain relief (extension period): verbal rating scale

  Every 6 months after first plaster application in the extension period up to 4.4 years (or early withdrawal)

• Number of participants with treatment emergent adverse events (extension period)

  Every 6 months after first plaster application in the extension period up to 4.4 years (including a follow-up visit 1-2 weeks after last regular 6-month visit or early withdrawal)

Other Outcomes (9)

• Allodynia severity rating (main study period)

  At screening/enrollment, and after 1, 6, 12, 18, 26, 34, 42, and 52 weeks (or early withdrawal)

• Clinical Global Impression of Change (CGIC) (main study period)

  At 26 weeks of treatment in the main study period and at the final visit (at 52 weeks, or early withdrawal)

• Short Form-36 Quality of Life Index (SF-36) (main study period)

  At screening, and after 12, 26, 42, and 52 weeks (or early withdrawal)

Study Arms (1)

Lidocaine 5% medicated plaster

EXPERIMENTAL

Up to 3 plasters were applied per day.

Drug: Lidocaine 5% medicated plaster

Interventions

Lidocaine 5% medicated plaster DRUG

Topical application at the site of skin affected by painful PHN for up to 12 hours per day (plaster-free interval at least 12 hours).

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

Lidocaine 5% medicated plaster

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.
• Only for patients who had not participated in the KF10004/01 (NCT03745404) study: Pain score of at least 4, based on an 11-point numerical rating scale (NRS) (scale of 0-10), at the screening visit. The pain assessment is the participant's recall of the pain intensity since the previous week.
• Written informed consent given.

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, except previous participation in the KF10004/01 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 PHN.
• 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 (2)

• Hans G, Sabatowski R, Binder A, Boesl I, Rogers P, Baron R. Efficacy and tolerability of a 5% lidocaine medicated plaster for the topical treatment of post-herpetic neuralgia: results of a long-term study. Curr Med Res Opin. 2009 May;25(5):1295-305. doi: 10.1185/03007990902901368.

  PMID: 19366301 RESULT

• Sabatowski R, Hans G, Tacken I, Kapanadze S, Buchheister B, Baron R. Safety and efficacy outcomes of long-term treatment up to 4 years with 5% lidocaine medicated plaster in patients with post-herpetic neuralgia. Curr Med Res Opin. 2012 Aug;28(8):1337-46. doi: 10.1185/03007995.2012.707977. Epub 2012 Jul 18.

  PMID: 22769236 RESULT

MeSH Terms

Conditions

Neuralgia, Postherpetic

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

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: December 5, 2018
• Study Start: July 16, 2003
• Primary Completion: July 12, 2005
• Study Completion: February 12, 2009
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share