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

Purpose

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.

Condition	Intervention	Phase
Pain Chronic Pain Neuropathic Pain Postoperative Pain	Drug: Lidocaine 5% medicated plaster Drug: Placebo plaster	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Chronic Pain

Drug Information available for: Lidocaine hydrochloride Lidocaine

U.S. FDA Resources

Further study details as provided by Grünenthal GmbH:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
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. [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
Weekly mean pain intensity before plaster removal based on the average pain intensity during the last 24 hours. [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
Weekly mean pain intensity before plaster removal based on current pain intensity before plaster removal. [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
Total score of the painDETECT Pain Questionnaire during the Double blind Treatment Period. [ Time Frame: Day 85 ] [ Designated as safety issue: No ]
Pain intensity from mechanical dynamic allodynia (brush) testing. [ Time Frame: Day 85 ] [ Designated as safety issue: No ]
Anxiety and depression scores of HADS. [ Time Frame: Day 85 ] [ Designated as safety issue: No ]
Total score of quality of life by means of EQ 5D. [ Time Frame: Day 85 ] [ Designated as safety issue: No ]
Total score in quality of sleep using CPSI. [ Time Frame: Day 85 ] [ Designated as safety issue: No ]
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. [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
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. [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
Weekly mean pain intensity change from baseline before plaster removal based on the average pain intensity during the last 24 hours. [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
Weekly mean pain intensity change from baseline before plaster removal based on current pain intensity before plaster removal. [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
Change from baseline in the total score of the painDETECT Pain Questionnaire during the Double blind Treatment Period. [ Time Frame: Day 85 ] [ Designated as safety issue: No ]
Change from baseline in pain intensity from mechanical dynamic allodynia (brush) testing. [ Time Frame: Day 85 ] [ Designated as safety issue: No ]
Change from baseline in anxiety and depression scores of HADS. [ Time Frame: Day 85 ] [ Designated as safety issue: No ]
Change from baseline in total score of quality of life by means of EQ 5D. [ Time Frame: Day 85 ] [ Designated as safety issue: No ]
Change from baseline in total score in quality of sleep using CPSI. [ Time Frame: Day 85 ] [ Designated as safety issue: No ]

Estimated Enrollment:	600
Study Start Date:	October 2012
Estimated Primary Completion Date:	July 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Lidocaine plaster Topical hydrogel plaster	Drug: Lidocaine 5% medicated plaster
Placebo Comparator: Placebo plaster Topical hydrogel plaster	Drug: Placebo plaster

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female subjects aged >18 years
Subjects suffering from moderate to severe localized chronic PoNP following surgery (e.g., thoracotomy, total knee replacement, cholecystectomy, mastectomy, inguinal hernia repair, varicose vein stripping)
Localized PoNP present for ≥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 on the 11 point NRS.

Exclusion Criteria:

Participation in another trial or devices parallel to, or <30 days prior to enrollment, or previous participation 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.
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.
For subjects 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 site of surgery.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01752322

Contacts

Contact: René Allard

clinical-trials@grunenthal.com

Locations

Austria
AUT004	Recruiting
Klagenfurt, Austria
AUT005	Recruiting
Senftenberg, Austria
AUT003	Recruiting
Vienna, Austria
AUT002	Recruiting
Vienna, Austria
Belgium
BEL001	Recruiting
Gozée, Belgium
BEL004	Recruiting
Ham, Belgium
BEL002	Recruiting
Natoye, Belgium
BEL003	Recruiting
Retie, Belgium
BEL005	Recruiting
Tremelo, Belgium
Denmark
DNK002	Recruiting
Aalborg, Denmark
DNK001	Recruiting
Odense, Denmark
France
FRA004	Recruiting
Amiens, France
FRA002	Recruiting
Bordeaux, France
FRA001	Recruiting
Boulogne Billancourt, France
FRA003	Recruiting
Le Chesnay, France
FRA005	Recruiting
Lille, France
FRA010	Recruiting
Montauban, France
Italy
ITA004	Recruiting
Firenze, Italy
ITA003	Recruiting
Napoli, Italy
ITA001	Recruiting
Rome, Italy
Spain
ESP003	Recruiting
Barcelona, Spain
ESP001	Recruiting
Barcelona, Spain
ESP002	Recruiting
Barcelona, Spain
ESP005	Recruiting
Madrid, Spain
ESP004	Recruiting
Madrid, Spain

Sponsors and Collaborators

Grünenthal GmbH

Investigators

Study Director:

Study Director

Grünenthal GmbH

More Information

No publications provided

Responsible Party:	Grünenthal GmbH
ClinicalTrials.gov Identifier:	NCT01752322 History of Changes
Other Study ID Numbers:	KF10004/10, 2012‐000347‐28
Study First Received:	September 12, 2012
Last Updated:	February 20, 2013
Health Authority:	France: Agence Nationale de Sécurité du Médicament et des produits de santé Belgium: Federal Agency for Medicinal Products and Health Products Denmark: Danish Health and Medicines Authority Spain: Agencia Española de Medicamentos y Productos Sanitarios

Additional relevant MeSH terms:

Neuralgia
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Lidocaine

Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 18, 2013