Loading clinical trials...

COMPLETEDPHASE3

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

Efficacy and Safety of Lidocaine 5% Medicated Plaster in Localized Chronic Post-operative Neuropathic Pain

NCT01752322•Grünenthal GmbH

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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.
+5 more criteria

Locations (42)

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

Key Dates

Start Date

October 1, 2012

Primary Completion Date

June 1, 2016

Completion Date

June 1, 2016

Last Updated

July 6, 2016

Enrollment

444

ACTUAL participants

Conditions

PainChronic PainNeuropathic PainPostoperative Pain

Interventions

Lidocaine 5% medicated plaster

DRUG

Placebo plaster

DRUG

Effect of Virtual Reality on Patient's Comfort During Cardiac Electronic Device Implantation.

NCT06346132

Virtual RealityMedical Device+2 more

View study

RECRUITINGPHASE1

A Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Patients With Knee Osteoarthritis

NCT07351968

Moderate Pain in Knee OsteoarthritisSevere Pain in Knee Osteoarthritis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 6, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Effect of Virtual Reality on Patient's Comfort During Cardiac Electronic Device Implantation.

A Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Patients With Knee Osteoarthritis

Comparison Between Tranversus Abdominis Plane (TAP) Block With Only Bupivacaine and TAP Block With Bupivacaine Plus Ketamine in Reducing Postoperative Pain After Total Abdominal Hystrectomy

Intertransverse Process Block to Improve Quality of Recovery and Pain Management in Adult Cardiac Surgical Patients

Evaluating Postoperative Pain and Antibacterial Effect of Ultrasonic and 980 nm Diode Laser Combination

Effects of Erector Spinae Plane Block on Postoperative Pain Following Lumbar Fusion Surgery