Overview

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:
GrĂ¼nenthal 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.