Post Herpetic NeuralgiaPhase 3NCT03745404
A Study With Lido-Patch and Placebo Plaster in Patients Suffering From Postherpetic Neuralgia (PHN)
A Phase 3 study testing Lidocaine 5% medicated Plaster in people with Post Herpetic Neuralgia, run by Grünenthal GmbH.
Trial 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). 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?
- Yes, some participants may receive a placebo
- How many people
- 265 participants
- Where
- No sites listed yet
- Study dates
- 29 Apr 2003to 30 Jun 2004
- 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.
- 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.
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.
- 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 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.
About this study
Official title: A Double-blind, Multicentre, Multiple-dose, Enriched Enrolment, Randomized-withdrawal, Parallel-group Phase III Study With Lido-Patch and Corresponding Placebo Plaster in Patients Suffering From Postherpetic Neuralgia (PHN)
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).
Read the detailed description
Participants were treated up to 10 weeks in this study: an 8-week Run-in Phase of open-label treatment with Lido-Patch was followed by a 2-day to 14-day Double-blind Phase with Lido-Patch or Placebo Patch treatment. Only participants responding to open-label treatment with Lido-Patch were included in the Double-blind Phase. In a Follow-up Phase without treatment, the safety of participants was monitored for 1-2 weeks. Alternatively, patch application could be continued for up to 12 months in the clinical study KF10004/02.
- Conditions
- Post Herpetic Neuralgia
- Being tested
- Lidocaine 5% medicated Plaster, Placebo Plaster
- Keywords
- Post herpetic neuralgia, Lidocaine, Herpes zoster
- Medical subject headings
- Neuralgia, Postherpetic, Herpes Zoster
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), Lidoderm (Trade Mark), Neurodol Tissugel (Trade Mark)
Placebo PlasterDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Placebo Plaster |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Day 1 until time to exit in Double-blind Phase (maximum Day 14)
Secondary outcomes (8)
Daily Pain Intensity: NRS
Pain intensity was assessed as "pain right now" directly before patch application and before patch removal, and as "24-hour average pain" before patch removal using an 11-point Numeric Rating Scale (NRS from 0 = no pain to 10 = pain as bad as you can imagine).
Measured: From screening visit (Week -1) to end of Double-blind Phase visit (Week 10)
Daily Pain Relief
Pain relief was defined as relief at the time point directly before patch removal in comparison to the time point directly before patch application. Pain relief was assessed using a 6-item relief scale (VRS) with categories 1 = worse, 2 = no pain relief, 3 = slight, 4 = moderate, 5 = a lot, and 6 = complete.
Measured: From screening visit (Week -1) to end of Double-blind Phase visit (Week 10)
Weekly Average 24-hour Pain Intensity: NRS
The weekly average of the 24-hour average pain intensity was calculated based on corresponding daily pain intensities over the last week before the respective visit. Pain intensities were assessed using an 11-point Numeric Rating Scale (NRS from 0 = no pain to 10 = pain as bad as you can imagine).
Measured: 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
The weekly average of the current pain ("pain right now") intensities before patch application or before patch removal were calculated based on corresponding daily pain intensities over the last week before the respective visit. Pain intensities were assessed using an 11-point Numeric Rating Scale (NRS from 0 = no pain to 10 = pain as bad as you can imagine).
Measured: 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
The weekly average pain relief was calculated based on daily pain relief over the last week before visit. Pain relief was assessed using a 6-item relief scale (VRS) with categories 1 = worse, 2 = no pain relief, 3 = slight, 4 = moderate, 5 = a lot, and 6 = complete.
Measured: During Run-in Phase (visits after 1 and 4 weeks), after 8 weeks, and after 10 weeks (Double-bind Phase)
Weekly Worst Pain Intensity: NRS
Weekly worst pain intensity was assessed in the last week before the visit using an 11-point NRS (from 0 = no pain to 10 = pain as bad as you can imagine).
Measured: During Run-in Phase (visits after 1 and 4 weeks), after 8 weeks, and after 10 weeks (Double-blind Phase)
Weekly Average Pain Intensity: NRS
Weekly average pain intensity was assessed in the last week before the visit using an 11-point NRS (from 0 = no pain to 10 = pain as bad as you can imagine).
Measured: During Run-in Phase (visits after 1 and 4 weeks), after 8 weeks, and after 10 weeks (Double-blind Phase)
Weekly Least Pain Intensity: NRS
Weekly least pain intensity was assessed in the last week before the respective visit using an 11-point NRS (from 0 = no pain to 10 = pain as bad as you can imagine).
Measured: During Run-in Phase (visits after 1 and 4 weeks), after 8 weeks, and after 10 weeks (Double-blind Phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start29 Apr 2003
- Primary completion30 Jun 2004
- Study completion30 Jun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Herpetic NeuralgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grünenthal GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Grünenthal Study Director, Study director, Grünenthal GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03745404
- Sponsor's protocol ID
- KF10004/01
- Status last verified
- Sep 2023
- First submitted
- 15 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
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.
PubMed 19432499
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Multicentre, Multiple-dose, Enriched Enrolment, Randomized-withdrawal, Parallel-group Phase III Study With Lido-Patch and Corresponding Placebo Plaster in Patients Suffering From Postherpetic Neuralgia (PHN)
- ClinicalTrials.gov ID
- NCT03745404
- Acronym / sponsor ID
- KF10004/01
- Conditions
- Post Herpetic Neuralgia
- Keywords
- Post herpetic neuralgia, Lidocaine, Herpes zoster
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- Grünenthal GmbHIndustry (pharma, biotech, devices)
- Study start
- 29 Apr 2003 (actual)
- Primary completion
- 30 Jun 2004 (actual)
- Study completion
- 30 Jun 2004 (actual)
- First posted
- 19 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Participants were treated up to 10 weeks in this study: an 8-week Run-in Phase of open-label treatment with Lido-Patch was followed by a 2-day to 14-day Double-blind Phase with Lido-Patch or Placebo Patch treatment. Only participants responding to open-label treatment with Lido-Patch were included in the Double-blind Phase. In a Follow-up Phase without treatment, the safety of participants was monitored for 1-2 weeks. Alternatively, patch application could be continued for up to 12 months in the clinical study KF10004/02.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Lido-Patch (Open-label Run-in Phase) | Experimental | Drug: Lidocaine 5% medicated PlasterAll 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. |
| Lido-Patch (Double-blind Phase) | Experimental | Drug: Lidocaine 5% medicated PlasterUp 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. |
| Placebo Patch (Double-blind Phase) | Placebo comparator | Drug: Placebo PlasterUp 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine 5% medicated PlasterAlso: Versatis (Trade Mark), Lidoderm (Trade Mark), Neurodol Tissugel (Trade Mark) | Drug | Lido-Patch (Double-blind Phase), Lido-Patch (Open-label Run-in Phase) |
| Placebo Plaster | Drug | Placebo Patch (Double-blind Phase) |
Primary outcome
Time-to-exit in Double-blind Phase Due to Lack of Efficacy
Time frame: From Day 1 until time to exit in Double-blind Phase (maximum Day 14)
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.
8 secondary outcomes
Daily Pain Intensity: NRS
Time frame: From screening visit (Week -1) to end of Double-blind Phase visit (Week 10)
Daily Pain Relief
Time frame: From screening visit (Week -1) to end of Double-blind Phase visit (Week 10)
Weekly Average 24-hour Pain Intensity: NRS
Time frame: 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
Time frame: 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
Time frame: During Run-in Phase (visits after 1 and 4 weeks), after 8 weeks, and after 10 weeks (Double-bind Phase)
Weekly Worst Pain Intensity: NRS
Time frame: During Run-in Phase (visits after 1 and 4 weeks), after 8 weeks, and after 10 weeks (Double-blind Phase)
Weekly Average Pain Intensity: NRS
Time frame: During Run-in Phase (visits after 1 and 4 weeks), after 8 weeks, and after 10 weeks (Double-blind Phase)
Weekly Least Pain Intensity: NRS
Time frame: During Run-in Phase (visits after 1 and 4 weeks), after 8 weeks, and after 10 weeks (Double-blind Phase)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Results publication: PubMed 19432499Binder 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grünenthal Study Director study director
Grünenthal GmbH
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 8 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. Some participants in this study may receive a placebo. 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?
Time-to-exit in Double-blind Phase Due to Lack of Efficacy (time frame: From Day 1 until time to exit in Double-blind Phase (maximum Day 14)). 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 NCT03745404, which also lists 1 linked publication.
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.