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Efficacy and Tolerability of Lidocaine Plaster for Treatment of Long-term Local Nerve Pain

Primary Purpose

Pain, Chronic Pain, Neuropathic Pain

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lidocaine 5% medicated plaster
Placebo plaster
Sponsored by
Grünenthal GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female subjects aged 18 years or older.
  • Subjects suffering from moderate to severe localized chronic PoNP (post operative neuropathic pain) pain following surgery (e.g., thoracotomy, total/partial knee replacement, cholecystectomy, mastectomy, inguinal hernia repair, varicose vein stripping).
  • Localized PoNP present for at least 3 months.
  • Size of the affected painful skin area is not larger than the size of 3 plasters.
  • Intact skin besides the scar of surgery in the area of plasters application
  • Baseline average pain intensity of 4 or greater on the 11 point pain intensity Numeric Rating Scale.

Exclusion Criteria:

  • Participation in another trial (with medicine or a device under investigation) in parallel or less than 30 days prior to enrollment in this trial.
  • Previous enrollment in this trial.
  • History of dependency or active drug abuse (alcohol, medication) during the 1 year prior to enrollment.
  • Evidence or history (during the 3 years prior to enrollment) of neurotic personality or psychiatric illness that in the investigator's opinion may affect efficacy or safety assessments or may compromise the subjects safety during trial participation.
  • Pregnant or breastfeeding women or women of childbearing potential who are sexually active without satisfactory contraception.
  • Any surgery performed in the 3 months prior to enrollment, which may affect efficacy or safety assessment.
  • Any surgery scheduled or expected during the trial.
  • Clinically significant disease (e.g., acquired immunodeficiency syndrome) or condition that may affect efficacy or safety assessments, or any other reason which, in investigator's opinion, may preclude the subject's participation in the trial.
  • History of malignancy (with the exception of neoplasia related to the trial indication) within 2 years prior to enrollment.
  • Subject with PoNP related to a surgery due to neoplasia: suspected residual neoplasia or metastases.
  • Pending litigation due to chronic pain or disability.
  • Total anesthesia in the cutaneous area neurologically related to the location of the surgical intervention.
  • Hypersensitivity to the lidocaine 5% medicated plaster, its excipients, or anesthetics of the amide type.
  • Any former use of topical lidocaine in the area of localized chronic PoNP.
  • Severe renal, hepatic or heart disorder.

Sites / Locations

  • AUT004
  • AUT005
  • AUT006
  • AUT002
  • AUT003
  • AUT001
  • BEL001
  • BEL006
  • BEL004
  • BEL007
  • BEL002
  • BRA005
  • BRA002
  • BRA001
  • BR008
  • BRA003
  • BRA006
  • BRA007
  • DNK005
  • DNK004
  • DNK001
  • FRA004
  • FRA002
  • FRA001
  • FRA003
  • FRA005
  • FRA010
  • FRA006
  • FRA009
  • FRA008
  • FR007
  • ITA004
  • ITA003
  • ITA001
  • ESP001
  • ESP002
  • ESP006
  • ESP005
  • GBR003
  • GBR001
  • GBR004
  • GBR002

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lidocaine plaster

Placebo plaster

Arm Description

Topical hydrogel plaster

Topical hydrogel plaster

Outcomes

Primary Outcome Measures

Change from baseline of recorded average pain intensity values during the last 24 hours, averaged over the 7 days of Week 12 of the Double-blind Treatment Period.

Secondary Outcome Measures

Mean pain intensity based on the average pain intensity during the last 24 hours, calculated over the last 4 weeks and 12 weeks of the Double blind Treatment Period.
Mean pain intensity based on the current pain intensity before plaster removal, calculated over the last 7 days, 4 weeks, and 12 weeks of the Double blind Treatment Period.
Weekly mean pain intensity before plaster removal based on the average pain intensity during the last 24 hours.
Weekly mean pain intensity before plaster removal based on current pain intensity before plaster removal.
Final score of the painDETECT Pain Questionnaire during the Double blind Treatment Period.
Pain intensity from mechanical dynamic allodynia (brush) testing.
Anxiety and depression scores of HADS.
The weighted Health Status Index of quality of life by means of EQ 5D.
Total score in quality of sleep using CPSI.
Mean pain intensity change from baseline based on the average pain intensity during the last 24 hours, calculated over the last 4 weeks and 12 weeks of the Double blind Treatment Period.
Mean pain intensity change from baseline based on the current pain intensity before plaster removal, calculated over the last 7 days, 4 weeks, and 12 weeks of the Double blind Treatment Period.
Weekly mean pain intensity change from baseline before plaster removal based on the average pain intensity during the last 24 hours.
Weekly mean pain intensity change from baseline before plaster removal based on current pain intensity before plaster removal.
Change from baseline in the total score of the painDETECT Pain Questionnaire during the Double blind Treatment Period.
Change from baseline in pain intensity from mechanical dynamic allodynia (brush) testing.
Change from baseline in anxiety and depression scores of HADS.
Change from baseline in total score of quality of life by means of EQ 5D.
Change from baseline in total score in quality of sleep using CPSI.

Full Information

First Posted
September 12, 2012
Last Updated
July 5, 2016
Sponsor
Grünenthal GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01752322
Brief Title
Efficacy and Tolerability of Lidocaine Plaster for Treatment of Long-term Local Nerve Pain
Official Title
Efficacy and Safety of Lidocaine 5% Medicated Plaster in Localized Chronic Post-operative Neuropathic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Grünenthal GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this trial is to investigate the efficacy and safety of lidocaine 5% medicated plaster in localized chronic post-operative neuropathic pain in comparison to placebo plaster.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic Pain, Neuropathic Pain, Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
444 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine plaster
Arm Type
Experimental
Arm Description
Topical hydrogel plaster
Arm Title
Placebo plaster
Arm Type
Placebo Comparator
Arm Description
Topical hydrogel plaster
Intervention Type
Drug
Intervention Name(s)
Lidocaine 5% medicated plaster
Intervention Type
Drug
Intervention Name(s)
Placebo plaster
Primary Outcome Measure Information:
Title
Change from baseline of recorded average pain intensity values during the last 24 hours, averaged over the 7 days of Week 12 of the Double-blind Treatment Period.
Time Frame
Days 78-85
Secondary Outcome Measure Information:
Title
Mean pain intensity based on the average pain intensity during the last 24 hours, calculated over the last 4 weeks and 12 weeks of the Double blind Treatment Period.
Time Frame
up to 12 weeks
Title
Mean pain intensity based on the current pain intensity before plaster removal, calculated over the last 7 days, 4 weeks, and 12 weeks of the Double blind Treatment Period.
Time Frame
up to 12 weeks
Title
Weekly mean pain intensity before plaster removal based on the average pain intensity during the last 24 hours.
Time Frame
up to 12 weeks
Title
Weekly mean pain intensity before plaster removal based on current pain intensity before plaster removal.
Time Frame
up to 12 weeks
Title
Final score of the painDETECT Pain Questionnaire during the Double blind Treatment Period.
Time Frame
Day 85
Title
Pain intensity from mechanical dynamic allodynia (brush) testing.
Time Frame
Day 85
Title
Anxiety and depression scores of HADS.
Time Frame
Day 85
Title
The weighted Health Status Index of quality of life by means of EQ 5D.
Time Frame
Day 85
Title
Total score in quality of sleep using CPSI.
Time Frame
Day 85
Title
Mean pain intensity change from baseline based on the average pain intensity during the last 24 hours, calculated over the last 4 weeks and 12 weeks of the Double blind Treatment Period.
Time Frame
up to 12 weeks
Title
Mean pain intensity change from baseline based on the current pain intensity before plaster removal, calculated over the last 7 days, 4 weeks, and 12 weeks of the Double blind Treatment Period.
Time Frame
up to 12 weeks
Title
Weekly mean pain intensity change from baseline before plaster removal based on the average pain intensity during the last 24 hours.
Time Frame
up to 12 weeks
Title
Weekly mean pain intensity change from baseline before plaster removal based on current pain intensity before plaster removal.
Time Frame
up to 12 weeks
Title
Change from baseline in the total score of the painDETECT Pain Questionnaire during the Double blind Treatment Period.
Time Frame
Day 85
Title
Change from baseline in pain intensity from mechanical dynamic allodynia (brush) testing.
Time Frame
Day 85
Title
Change from baseline in anxiety and depression scores of HADS.
Time Frame
Day 85
Title
Change from baseline in total score of quality of life by means of EQ 5D.
Time Frame
Day 85
Title
Change from baseline in total score in quality of sleep using CPSI.
Time Frame
Day 85

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female subjects aged 18 years or older. Subjects suffering from moderate to severe localized chronic PoNP (post operative neuropathic pain) pain following surgery (e.g., thoracotomy, total/partial knee replacement, cholecystectomy, mastectomy, inguinal hernia repair, varicose vein stripping). Localized PoNP present for at least 3 months. Size of the affected painful skin area is not larger than the size of 3 plasters. Intact skin besides the scar of surgery in the area of plasters application Baseline average pain intensity of 4 or greater on the 11 point pain intensity Numeric Rating Scale. Exclusion Criteria: Participation in another trial (with medicine or a device under investigation) in parallel or less than 30 days prior to enrollment in this trial. Previous enrollment in this trial. History of dependency or active drug abuse (alcohol, medication) during the 1 year prior to enrollment. Evidence or history (during the 3 years prior to enrollment) of neurotic personality or psychiatric illness that in the investigator's opinion may affect efficacy or safety assessments or may compromise the subjects safety during trial participation. Pregnant or breastfeeding women or women of childbearing potential who are sexually active without satisfactory contraception. Any surgery performed in the 3 months prior to enrollment, which may affect efficacy or safety assessment. Any surgery scheduled or expected during the trial. Clinically significant disease (e.g., acquired immunodeficiency syndrome) or condition that may affect efficacy or safety assessments, or any other reason which, in investigator's opinion, may preclude the subject's participation in the trial. History of malignancy (with the exception of neoplasia related to the trial indication) within 2 years prior to enrollment. Subject with PoNP related to a surgery due to neoplasia: suspected residual neoplasia or metastases. Pending litigation due to chronic pain or disability. Total anesthesia in the cutaneous area neurologically related to the location of the surgical intervention. Hypersensitivity to the lidocaine 5% medicated plaster, its excipients, or anesthetics of the amide type. Any former use of topical lidocaine in the area of localized chronic PoNP. Severe renal, hepatic or heart disorder.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Grünenthal GmbH
Official's Role
Study Director
Facility Information:
Facility Name
AUT004
City
Klagenfurt
Country
Austria
Facility Name
AUT005
City
Senftenberg
Country
Austria
Facility Name
AUT006
City
Vienna
ZIP/Postal Code
1100
Country
Austria
Facility Name
AUT002
City
Vienna
Country
Austria
Facility Name
AUT003
City
Vienna
Country
Austria
Facility Name
AUT001
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
BEL001
City
Gozée
Country
Belgium
Facility Name
BEL006
City
Halen
ZIP/Postal Code
3545
Country
Belgium
Facility Name
BEL004
City
Ham
Country
Belgium
Facility Name
BEL007
City
Lanaken
ZIP/Postal Code
3620
Country
Belgium
Facility Name
BEL002
City
Natoye
Country
Belgium
Facility Name
BRA005
City
Barretos
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
BRA002
City
Itajai
ZIP/Postal Code
88301-220
Country
Brazil
Facility Name
BRA001
City
Porto Alegre
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
BR008
City
Salvador
ZIP/Postal Code
40170-150
Country
Brazil
Facility Name
BRA003
City
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
BRA006
City
São Paulo
ZIP/Postal Code
01323-903
Country
Brazil
Facility Name
BRA007
City
São Paulo
ZIP/Postal Code
04032-060
Country
Brazil
Facility Name
DNK005
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
Facility Name
DNK004
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Facility Name
DNK001
City
Odense
Country
Denmark
Facility Name
FRA004
City
Amiens
Country
France
Facility Name
FRA002
City
Bordeaux
Country
France
Facility Name
FRA001
City
Boulogne Billancourt
Country
France
Facility Name
FRA003
City
Le Chesnay
Country
France
Facility Name
FRA005
City
Lille
Country
France
Facility Name
FRA010
City
Montauban
Country
France
Facility Name
FRA006
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
FRA009
City
Paris
ZIP/Postal Code
75004
Country
France
Facility Name
FRA008
City
Saint-Priest en Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
FR007
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
ITA004
City
Firenze
Country
Italy
Facility Name
ITA003
City
Napoli
Country
Italy
Facility Name
ITA001
City
Rome
Country
Italy
Facility Name
ESP001
City
Barcelona
Country
Spain
Facility Name
ESP002
City
Barcelona
Country
Spain
Facility Name
ESP006
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
ESP005
City
Madrid
Country
Spain
Facility Name
GBR003
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
GBR001
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
GBR004
City
Liverpool
ZIP/Postal Code
L9 7LJ
Country
United Kingdom
Facility Name
GBR002
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
30614286
Citation
Palladini M, Boesl I, Koenig S, Buchheister B, Attal N. Lidocaine medicated plaster, an additional potential treatment option for localized post-surgical neuropathic pain: efficacy and safety results of a randomized, placebo-controlled trial. Curr Med Res Opin. 2019 May;35(5):757-766. doi: 10.1080/03007995.2019.1565709. Epub 2019 Jan 21.
Results Reference
derived

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Efficacy and Tolerability of Lidocaine Plaster for Treatment of Long-term Local Nerve Pain

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