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

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Grünenthal GmbH
• Treatments: Lidocaine

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.