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

Grünenthal

Status and phase

Completed

Phase 3

Conditions

Postoperative Pain

Neuropathic Pain

Chronic Pain

Pain

Treatments

Drug: Placebo plaster

Drug: Lidocaine 5% medicated plaster

Study type

Interventional

Funder types

Industry

Identifiers

NCT01752322

KF10004/10

2012-000347-28 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

444 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.