Efficacy and safety of lidocaine 5% medicated plaster in localizedchronic post-operative neuropathic pain

Grünenthal GmbH0 sites360 target enrollmentJuly 9, 2012

Overview

No summary available.

Registry

who.int

Start Date

July 9, 2012

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Male or female subjects aged \>18 years at Visit 1\.
•Subjects having understood the nature of the trial and having given written informed consent.
•Subjects able to communicate meaningfully with investigational site staff, to comply with investigational site staff instructions, to comply with the planned use of the IMPs, to complete the questionnaires, and to use the e\-diaries.
•For women of childbearing potential, a negative pregnancy test (sample taken at Visit 1\).
•Subjects suffering from moderate to severe localized chronic PoNP following surgery. Localized chronic PoNP is defined as chronic neuropathic pain on the surface of a single cutaneous area neurologically related to the site of surgery and following surgery (e.g., thoracotomy, total knee replacement, cholecystectomy, mastectomy, inguinal hernia repair, varicose vein stripping).
•The surgery leading to PoNP was performed 3 to 36 months prior to Visit 1\.
•Pain intensity at Visit 1 (subject?s average pain during the last 24 hours before the Enrollment Visit) of ?4 on the 11 point NRS.
•Localized PoNP present for ?3 months prior to Visit 1\.
•Douleur neuropathique 4 (DN4\) questionnaire score ?4/10 at Visit 1\.
•Size of the affected painful skin area is not larger than the size of 3 plasters.

•Participation in another trial of IMPs or devices parallel to, or \<30 days prior to Visit 1, or previous participation in this trial.
•Any dependency of the subject to the investigator or the trial site, e.g., employees with direct involvement in the proposed trial or in other trials under the direction of this investigator or trial site, as well as family members of the employees or the investigator.
•History of dependency or ?active? drug abuse (alcohol, medication) during the 1 year prior to Visit 1\.
•Evidence or history (during the 3 years prior to Visit 1\) of neurotic personality or psychiatric illness.
•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 Visit 1, which may affect efficacy or safety assessment, or 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.
•Any painful procedure planned during the trial that may, in the opinion of the investigator, affect the efficacy or safety assessments.
•History of malignancy (with the exception of neoplasia related to the trial indication) within 2 years prior to Visit 1\.
•Pending litigation due to chronic pain or disability.