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

Grünenthal GmbH42 sites in 8 countries444 target enrollmentOctober 2012

ConditionsPain Chronic Pain Neuropathic Pain Postoperative Pain

InterventionsLidocaine 5% medicated plaster Placebo plaster

DrugsLidocaine 5% medicated plaster Placebo plaster

Overview

Phase: Phase 3
Intervention: Lidocaine 5% medicated plaster
Conditions: Pain
Sponsor: Grünenthal GmbH
Enrollment: 444
Locations: 42
Primary Endpoint: Change from baseline of recorded average pain intensity values during the last 24 hours, averaged over the 7 days of Week 12 of the Double-blind Treatment Period.
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 2012

End Date

June 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Grünenthal GmbH

Responsible Party

Sponsor

Eligibility 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.

Arms & Interventions

Lidocaine plaster

Topical hydrogel plaster

Intervention: Lidocaine 5% medicated plaster

Placebo plaster

Topical hydrogel plaster

Intervention: Placebo plaster

Outcomes

Primary Outcomes

Change from baseline of recorded average pain intensity values during the last 24 hours, averaged over the 7 days of Week 12 of the Double-blind Treatment Period.

Time Frame: Days 78-85

Secondary Outcomes

Mean pain intensity based on the current pain intensity before plaster removal, calculated over the last 7 days, 4 weeks, and 12 weeks of the Double blind Treatment Period.(up to 12 weeks)
Mean pain intensity based on the average pain intensity during the last 24 hours, calculated over the last 4 weeks and 12 weeks of the Double blind Treatment Period.(up to 12 weeks)
Weekly mean pain intensity before plaster removal based on the average pain intensity during the last 24 hours.(up to 12 weeks)
Weekly mean pain intensity before plaster removal based on current pain intensity before plaster removal.(up to 12 weeks)
Final score of the painDETECT Pain Questionnaire during the Double blind Treatment Period.(Day 85)
Pain intensity from mechanical dynamic allodynia (brush) testing.(Day 85)
Anxiety and depression scores of HADS.(Day 85)
The weighted Health Status Index of quality of life by means of EQ 5D.(Day 85)
Total score in quality of sleep using CPSI.(Day 85)
Mean pain intensity change from baseline based on the average pain intensity during the last 24 hours, calculated over the last 4 weeks and 12 weeks of the Double blind Treatment Period.(up to 12 weeks)
Mean pain intensity change from baseline based on the current pain intensity before plaster removal, calculated over the last 7 days, 4 weeks, and 12 weeks of the Double blind Treatment Period.(up to 12 weeks)
Weekly mean pain intensity change from baseline before plaster removal based on the average pain intensity during the last 24 hours.(up to 12 weeks)
Weekly mean pain intensity change from baseline before plaster removal based on current pain intensity before plaster removal.(up to 12 weeks)
Change from baseline in the total score of the painDETECT Pain Questionnaire during the Double blind Treatment Period.(Day 85)
Change from baseline in pain intensity from mechanical dynamic allodynia (brush) testing.(Day 85)
Change from baseline in anxiety and depression scores of HADS.(Day 85)
Change from baseline in total score of quality of life by means of EQ 5D.(Day 85)
Change from baseline in total score in quality of sleep using CPSI.(Day 85)