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Post Herpetic NeuralgiaPhase 3NCT03765697

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

A Phase 3 study testing Lidocaine 5% medicated plaster in people with Post Herpetic Neuralgia, run by Grünenthal GmbH.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Post Herpetic Neuralgia
What is being tested?
Lidocaine 5% medicated plaster
Could I receive a placebo?
No, everyone receives an active treatment
How many people
259 participants
Where
No sites listed yet
Study dates
16 Jul 2003to 12 Feb 2009
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

About this study

Official title: An Open-label, Multicenter, Multiple-dose, Phase III Study With Lidocaine 5% Medicated Plaster in Patients Suffering From Postherpetic Neuralgia

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.

Read the detailed description

The main period was performed in 34 sites in 12 European countries (259 participants). Treatment duration was up to 12 months. All participants applied lidocaine 5% medicated plaster (containing 700 mg lidocaine per plaster) topically at the site of the skin affected by painful PHN. Depending on the size of the affected skin area, up-to 3 plasters were simultaneously applied for up to 12 hours per day (with a plaster-free interval of at least 12 hours). Study objectives of the main period were to evaluate the local and systemic safety profile and the analgesic efficacy of lidocaine 5% medicated plaster, and to evaluate the pharmacokinetics of lidocaine and its metabolite 2,6-xylidine in the target population after multiple administrations of lidocaine 5% medicated plaster by means of population kinetics. The study results were planned to be evaluated descriptively.

102 participants who were satisfied with the treatment in the main study period entered the open-label extension period with continued treatment. 27 sites in 12 countries participated in the extension period. Enrollment in the extension period coincided with last visit of the main period of the study. Treatment duration was up to 4.4 years in the extension period. The objective of the extension period was to evaluate the long-term local and systemic safety profile and the long-term analgesic efficacy of treatment with lidocaine 5% medicated plaster in the subpopulation who had completed 12 months of treatment in the open-label main study period.

Being tested
Lidocaine 5% medicated plaster
Keywords
post-herpetic neuralgia, lidocaine
Medical subject headings
Neuralgia, Postherpetic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lidocaine 5% medicated plasterDrug

    Also called Versatis (Trade Mark), Neurodol Tissugel (Trade Mark), Lidoderm (Trade Mark)

    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).

Study groups in NCT03765697
Study groupRoleWhat they receive
Lidocaine 5% medicated plasterExperimentalUp to 3 plasters were applied per day.
Receives: Drug: Lidocaine 5% medicated plaster

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From first plaster application up to 12 months

Secondary outcomes (4)

  1. Pain relief (main study period): verbal rating scale

    Pain relief was assessed starting 1 week (new participants) or 6 weeks after treatment initiation (participants from KF10004/01) until the final visit of the main study period. The average pain relief during the last week before the visit was assessed using a 6-item verbal rating scale (VRS) with categories 1 = worse, 2 = no pain relief, 3 = slight, 4 = moderate, 5 = a lot, and 6 = complete.

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

  2. Pain intensity (main study period): Numeric Rating Scale

    The participant's recall of worst, least, and average pain intensity in the last week prior to each visit were assessed using an 11-point Numeric Rating Scale (NRS from 0 = no pain to 10 = pain as bad as you can imagine).

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

  3. Pain relief (extension period): verbal rating scale

    The participant's recall of average pain relief during plaster application in the last week prior to each visit in the extension period was assessed using a 6-item VRS with categories 1 = worse, 2 = no pain relief, 3 = slight, 4 = moderate, 5 = a lot, and 6 = complete.

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

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

    Treatment emergent adverse events were continually monitored for or asked about at each visit scheduled every 6 months in the extension period. The extension period lasted for up to 4.4 years and included a follow-up visit (1-2 weeks after last regular 6-month visit [or early withdrawal]). Adverse event incidences were calculated based on all events reported in the extension period.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2018
  2. Study start16 Jul 2003
  3. Primary completion12 Jul 2005
  4. Study completion12 Feb 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
259 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03765697
Sponsor's protocol ID
KF10004/02
Status last verified
Sep 2023
First submitted
27 Nov 2018
Last updated
13 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 19366301

  • 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.

    PubMed 22769236

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lidocaine 5% medicated plaster in people with Post Herpetic Neuralgia, run by Grünenthal GmbH.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with treatment emergent adverse events (main study period) (time frame: From first plaster application up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03765697, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.

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