Efficacy and Tolerability of Lidocaine Plaster for Treatment of Long-term Local Nerve Pain
NCT ID: NCT01752322
Last Updated: 2016-07-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
444 participants
INTERVENTIONAL
2012-10-31
2016-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Lidocaine plaster
Topical hydrogel plaster
Lidocaine 5% medicated plaster
Placebo plaster
Topical hydrogel plaster
Placebo plaster
Interventions
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Lidocaine 5% medicated plaster
Placebo plaster
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Grünenthal GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Grünenthal GmbH
Locations
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AUT004
Klagenfurt, , Austria
AUT005
Senftenberg, , Austria
AUT001
Vienna, , Austria
AUT006
Vienna, , Austria
AUT002
Vienna, , Austria
AUT003
Vienna, , Austria
BEL001
Gozée, , Belgium
BEL006
Halen, , Belgium
BEL004
Ham, , Belgium
BEL007
Lanaken, , Belgium
BEL002
Natoye, , Belgium
BRA005
Barretos, , Brazil
BRA002
Itajaí, , Brazil
BRA001
Porto Alegre, , Brazil
BR008
Salvador, , Brazil
BRA003
São Paulo, , Brazil
BRA006
São Paulo, , Brazil
BRA007
São Paulo, , Brazil
DNK005
Copenhagen, , Denmark
DNK004
Glostrup Municipality, , Denmark
DNK001
Odense, , Denmark
FRA004
Amiens, , France
FRA002
Bordeaux, , France
FRA001
Boulogne-Billancourt, , France
FRA003
Le Chesnay, , France
FRA005
Lille, , France
FRA010
Montauban, , France
FRA006
Nantes, , France
FRA009
Paris, , France
FRA008
Saint-Priest-en-Jarez, , France
FR007
Toulouse, , France
ITA004
Florence, , Italy
ITA003
Napoli, , Italy
ITA001
Rome, , Italy
ESP001
Barcelona, , Spain
ESP002
Barcelona, , Spain
ESP006
Madrid, , Spain
ESP005
Madrid, , Spain
GBR003
Cardiff, , United Kingdom
GBR001
Glasgow, , United Kingdom
GBR004
Liverpool, , United Kingdom
GBR002
Manchester, , United Kingdom
Countries
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References
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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.
Other Identifiers
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2012-000347-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
KF10004/10
Identifier Type: -
Identifier Source: org_study_id
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