Back to resultsA Study With Lidocaine 5% Medicated Plaster in Patients Suffering From Postherpetic Neuralgia
Primary Purpose
Post Herpetic Neuralgia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Lidocaine 5% medicated plaster
Sponsored by
About this trial
This is an interventional treatment trial for Post Herpetic Neuralgia focused on measuring post-herpetic neuralgia, lidocaine
Eligibility Criteria
Inclusion Criteria:
- 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.
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, 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lidocaine 5% medicated plaster
Arm Description
Up to 3 plasters were applied per day.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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).
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03765697
Brief Title
A Study With Lidocaine 5% Medicated Plaster in Patients Suffering From Postherpetic Neuralgia
Official Title
An Open-label, Multicenter, Multiple-dose, Phase III Study With Lidocaine 5% Medicated Plaster in Patients Suffering From Postherpetic Neuralgia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
July 16, 2003 (Actual)
Primary Completion Date
July 12, 2005 (Actual)
Study Completion Date
February 12, 2009 (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 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.
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.
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
259 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lidocaine 5% medicated plaster
Arm Type
Experimental
Arm Description
Up to 3 plasters were applied per day.
Intervention Type
Drug
Intervention Name(s)
Lidocaine 5% medicated plaster
Other Intervention Name(s)
Versatis (Trade Mark), Neurodol Tissugel (Trade Mark), Lidoderm (Trade Mark)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Number of participants with treatment emergent adverse events (main study period)
Description
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.
Time Frame
From first plaster application up to 12 months
Secondary Outcome Measure Information:
Title
Pain relief (main study period): verbal rating scale
Description
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.
Time Frame
After 1, 6, 12, 18, 26, 34, 42, and 52 weeks (or early withdrawal)
Title
Pain intensity (main study period): Numeric Rating Scale
Description
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).
Time Frame
At screening/enrollment and after 1, 6, 12, 18, 26, 34, 42, and 52 weeks (or early withdrawal)
Title
Pain relief (extension period): verbal rating scale
Description
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.
Time Frame
Every 6 months after first plaster application in the extension period up to 4.4 years (or early withdrawal)
Title
Number of participants with treatment emergent adverse events (extension period)
Description
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.
Time Frame
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 Pre-specified Outcome Measures:
Title
Allodynia severity rating (main study period)
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 by the participant.
Time Frame
At screening/enrollment, and after 1, 6, 12, 18, 26, 34, 42, and 52 weeks (or early withdrawal)
Title
Clinical Global Impression of Change (CGIC) (main study period)
Description
Investigators were asked to describe their overall impression of the change of the participant's condition/pain by answering the following question: "Compared to the patient's condition at admission to the project, how much has he/she changed?" The categorical 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.
Time Frame
At 26 weeks of treatment in the main study period and at the final visit (at 52 weeks, or early withdrawal)
Title
Short Form-36 Quality of Life Index (SF-36) (main study period)
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, and after 12, 26, 42, and 52 weeks (or early withdrawal)
Title
Short Form McGill Pain Questionnaire (SF-MPQ) (main study period)
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 is a visual analogue scale for rating pain intensity. Total score as well as sensory and affective sub-scores were calculated.
Time Frame
At screening, and after 12, 26, 42, and 52 weeks (or early withdrawal)
Title
Clinical Global Impression of Change (CGIC) (extension period)
Description
Investigators were asked to describe their overall impression of the change of the participant's condition/pain by answering the following question: "Compared to the patient's condition at admission to the project, how much has he/she changed?" (categories: not assessed = 0, very much improved = 1, much improved = 2, minimally improved = 3, no change = 4, minimally worse = 5, much worse = 6, very much worse = 7).
Time Frame
Every 6 months after first plaster application in the extension period up to 4.4 years (or early withdrawal)
Title
Patient's Global Impression of Change (PGIC) (extension period)
Description
Participants were asked to describe their overall impression of change of their condition/pain by answering the following question: "Compared to your pain at admission to the project, how much has it changed?" (categories: not assessed = 0, very much improved = 1, much improved = 2, minimally improved = 3, no change = 4, minimally worse = 5, much worse = 6, very much worse = 7).
Time Frame
Every 6 months after first plaster application in the extension period up to 4.4 years (or early withdrawal)
Title
Investigator's Global Evaluation of the IMP (extension period)
Description
The assessment of the investigational medicinal product (IMP) was made on a 5-point categorical scale (poor, fair, good, very good, excellent). Investigators responded to the following question: "How would you rate the study medication the patient received for pain?"
Time Frame
Every 6 months after first plaster application in the extension period up to 4.4 years (or early withdrawal)
Title
Patient's Global Evaluation of the IMP (extension period)
Description
The assessment of the IMP was made on a 5-point categorical scale (poor, fair, good, very good, excellent). Participants responded to the following question: "How would you rate the study medication you received for pain?"
Time Frame
Every 6 months after first plaster application in the extension period up to 4.4 years (or early withdrawal)
Title
Change in concomitant medication (main and extension period)
Description
For each participant, the number of different medications taken for PHN symptoms was determined at enrollment into the and at the last assessment in the study. Participants were classified into 5 groups: 0, 1, 2, 3, and more than 3 different substances taken. Shifts were determined for enrollment to last assessment in the study.
Time Frame
At enrollment into main study period; at last assessment in extension period (up to 5.4 years after enrollment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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, 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.
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
19366301
Citation
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.
Results Reference
result
PubMed Identifier
22769236
Citation
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. Erratum In: Curr Med Res Opin. 2014 Feb;30(2):329-30.
Results Reference
result
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A Study With Lidocaine 5% Medicated Plaster in Patients Suffering From Postherpetic Neuralgia
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