Back to resultsA Study With Lido-Patch and Placebo Plaster in Patients Suffering From Postherpetic Neuralgia (PHN)
Primary Purpose
Post Herpetic Neuralgia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Lidocaine 5% medicated Plaster
Placebo Plaster
Sponsored by
About this trial
This is an interventional treatment trial for Post Herpetic Neuralgia focused on measuring Post herpetic neuralgia, Lidocaine, Herpes zoster
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Lido-Patch (Open-label Run-in Phase)
Lido-Patch (Double-blind Phase)
Placebo Patch (Double-blind Phase)
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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.
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).
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).
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.
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).
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).
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03745404
Brief Title
A Study With Lido-Patch and Placebo Plaster in Patients Suffering From Postherpetic Neuralgia (PHN)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
April 29, 2003 (Actual)
Primary Completion Date
June 30, 2004 (Actual)
Study Completion Date
June 30, 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Grünenthal GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Herpetic Neuralgia
Keywords
Post herpetic neuralgia, Lidocaine, Herpes zoster
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Sequential Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Open-label enriched enrolment followed by double-blind treatment for 2 weeks.
Allocation
Randomized
Enrollment
265 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lido-Patch (Open-label Run-in Phase)
Arm Type
Experimental
Arm Description
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.
Arm Title
Lido-Patch (Double-blind Phase)
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Patch (Double-blind Phase)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lidocaine 5% medicated Plaster
Other Intervention Name(s)
Versatis (Trade Mark), Lidoderm (Trade Mark), Neurodol Tissugel (Trade Mark)
Intervention Type
Drug
Intervention Name(s)
Placebo Plaster
Primary Outcome Measure Information:
Title
Time-to-exit in Double-blind Phase Due to Lack of Efficacy
Description
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.
Time Frame
From Day 1 until time to exit in Double-blind Phase (maximum Day 14)
Secondary Outcome Measure Information:
Title
Daily Pain Intensity: NRS
Description
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).
Time Frame
From screening visit (Week -1) to end of Double-blind Phase visit (Week 10)
Title
Daily Pain Relief
Description
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.
Time Frame
From screening visit (Week -1) to end of Double-blind Phase visit (Week 10)
Title
Weekly Average 24-hour Pain Intensity: NRS
Description
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).
Time Frame
During Run-in Phase (visits after 1 and 4 weeks), after 8 weeks, and after 10 weeks (Double-blind Phase)
Title
Weekly Average Current Pain Intensity: NRS
Description
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).
Time Frame
During Run-in Phase (visits after 1 and 4 weeks), after 8 weeks, and after 10 weeks (Double-blind Phase)
Title
Weekly Average Pain Relief: VRS
Description
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.
Time Frame
During Run-in Phase (visits after 1 and 4 weeks), after 8 weeks, and after 10 weeks (Double-bind Phase)
Title
Weekly Worst Pain Intensity: NRS
Description
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).
Time Frame
During Run-in Phase (visits after 1 and 4 weeks), after 8 weeks, and after 10 weeks (Double-blind Phase)
Title
Weekly Average Pain Intensity: NRS
Description
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).
Time Frame
During Run-in Phase (visits after 1 and 4 weeks), after 8 weeks, and after 10 weeks (Double-blind Phase)
Title
Weekly Least Pain Intensity: NRS
Description
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).
Time Frame
During Run-in Phase (visits after 1 and 4 weeks), after 8 weeks, and after 10 weeks (Double-blind Phase)
Other Pre-specified Outcome Measures:
Title
Chronic Pain Sleep Inventory (CPSI)
Description
The CPSI is a 5-point verbal rating scale (VRS) designed to provide information on the influence of the pain on sleep quality with the items trouble falling asleep, needing sleep medication, and awakened by pain during the night/in the morning (categories of the VRS: never, rarely, sometimes, usually, always); in addition, the overall quality of sleep (categories of the VRS: poor, fair, good, very good, and excellent) was assessed. Participants were asked to complete the CPSI questionnaire at each visit.
Time Frame
From screening at each visit up to the final visit (Week 10) [6 time points in total]
Title
Short Form McGill Pain Questionnaire (SF-MPQ)
Description
The SF-MPQ includes 15 words (11 sensory, 4 affective). Each word or phrase is rated on a 4-point intensity scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe). In addition, the 6-point Present Pain Intensity (PPI) rating (no pain, mild, discomforting, distressing, horrible, excruciating) is included as a visual analogue scale for rating pain intensity.
Time Frame
At screening visit (Week -1), randomization visit (Week 8), and final visit (Week 10)
Title
Clinical Global Impression of Change (CGIC)
Description
Investigators were to describe their global impression of change (CGIC), i.e., the overall impression of the change of the participant's condition by answering the question "Compared to the patient's condition at admission to the project, how much has he/she changed?" The verbal rating scale comprises the categories not assessed [0], very much improved [1], much improved [2], minimally improved [3], no change [4], minimally worse [5], much worse [6], and very much worse [7]. When assessing the overall impression, the investigator was to refer to the Run-in Phase only.
Time Frame
Withdrawal visit (end of Run-in Phase) or final visit (end of Double-blind Phase)
Title
Short Form-36 Quality of Life Index (SF-36)
Description
The Short Form 36 Quality of Life Index (SF-36 [Trade Mark]) standard version with a 4-week recall period was used as a self-assessment.
Eleven questions were answered on binomial (Yes/No) or on 3-, 5-, or 6-point categorical scales to generate the 8 raw scales (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, Mental Health). Higher values of the raw scales represent a better outcome. The raw scales were converted into a transformed scale (transformed scale = [(actual raw score - lowest possible raw score) / possible raw score range] x 100).
Time Frame
At screening visit (Week -1), randomization visit (Week 8), and final visit (Week 10)
Title
Allodynia Assessment
Description
Allodynia severity was rated using the following categorical scale: 0 = no pain or discomfort to touch; 1 = uncomfortable, but tolerable to touch; 2 = painful; 3 = extremely painful, participant cannot stand touching.
The test was conducted by means of a brush (type N12). The painful PHN area was stroked with the brush and the intensity of allodynic pain was assessed.
Time Frame
From screening at each visit up to Week 10 (6 time points in total)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grünenthal Study Director
Organizational Affiliation
Grünenthal GmbH
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19432499
Citation
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.
Results Reference
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A Study With Lido-Patch and Placebo Plaster in Patients Suffering From Postherpetic Neuralgia (PHN)
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