Efficacy and Tolerability of Lidocaine Plaster for Treatment of Long-term Local Nerve Pain
Phase 3
Completed
- Conditions
- PainChronic PainNeuropathic PainPostoperative Pain
- Interventions
- Drug: Placebo plaster
- Registration Number
- NCT01752322
- Lead Sponsor
- Grünenthal GmbH
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 444
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lidocaine plaster Lidocaine 5% medicated plaster Topical hydrogel plaster Placebo plaster Placebo plaster Topical hydrogel plaster
- Primary Outcome Measures
Name Time Method 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. Days 78-85
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (42)
GBR001
🇬🇧Glasgow, United Kingdom
ITA004
🇮🇹Firenze, Italy
BRA002
🇧🇷Itajai, Brazil
BRA005
🇧🇷Barretos, Brazil
AUT002
🇦🇹Vienna, Austria
AUT006
🇦🇹Vienna, Austria
BEL001
🇧🇪Gozée, Belgium
FR007
🇫🇷Toulouse, France
AUT005
🇦🇹Senftenberg, Austria
BEL004
🇧🇪Ham, Belgium
ITA003
🇮🇹Napoli, Italy
ESP001
🇪🇸Barcelona, Spain
AUT003
🇦🇹Vienna, Austria
ESP006
🇪🇸Madrid, Spain
GBR003
🇬🇧Cardiff, United Kingdom
DNK001
🇩🇰Odense, Denmark
FRA001
🇫🇷Boulogne Billancourt, France
FRA003
🇫🇷Le Chesnay, France
FRA005
🇫🇷Lille, France
GBR002
🇬🇧Manchester, United Kingdom
BRA003
🇧🇷Sao Paulo, Brazil
BR008
🇧🇷Salvador, Brazil
AUT004
🇦🇹Klagenfurt, Austria
BEL007
🇧🇪Lanaken, Belgium
BRA007
🇧🇷São Paulo, Brazil
DNK004
🇩🇰Glostrup, Denmark
BRA006
🇧🇷São Paulo, Brazil
BRA001
🇧🇷Porto Alegre, Brazil
DNK005
🇩🇰Copenhagen, Denmark
FRA002
🇫🇷Bordeaux, France
FRA004
🇫🇷Amiens, France
FRA009
🇫🇷Paris, France
FRA008
🇫🇷Saint-Priest en Jarez, France
ESP002
🇪🇸Barcelona, Spain
ITA001
🇮🇹Rome, Italy
ESP005
🇪🇸Madrid, Spain
GBR004
🇬🇧Liverpool, United Kingdom
FRA010
🇫🇷Montauban, France
FRA006
🇫🇷Nantes, France
AUT001
🇦🇹Wien, Austria
BEL002
🇧🇪Natoye, Belgium
BEL006
🇧🇪Halen, Belgium