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

NCT01752322 | Completed Phase 3

• 2 other identifiers: KF10004/102012-000347-28
• Study Type: interventional
• Target: 444
• Locations: 8 countries
• Sites: 42

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.

Conditions

Pain; Chronic Pain; Neuropathic Pain; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• 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

• 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

• 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

Study Arms (2)

Lidocaine plaster

EXPERIMENTAL

Topical hydrogel plaster

Drug: Lidocaine 5% medicated plaster

Placebo plaster

PLACEBO COMPARATOR

Topical hydrogel plaster

Drug: Placebo plaster

Interventions

Lidocaine 5% medicated plaster DRUG

Lidocaine plaster

Placebo plaster DRUG

Placebo plaster

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Grünenthal GmbH: lead

Study Sites (42)

AUT004

Klagenfurt, Austria

Location

AUT005

Senftenberg, Austria

Location

AUT001

Vienna, 1090, Austria

Location

AUT006

Vienna, 1100, Austria

Location

AUT002

Vienna, Austria

Location

AUT003

Vienna, Austria

Location

BEL001

Gozée, Belgium

Location

BEL006

Halen, 3545, Belgium

Location

BEL004

Ham, Belgium

Location

BEL007

Lanaken, 3620, Belgium

Location

BEL002

Natoye, Belgium

Location

BRA005

Barretos, 14784-400, Brazil

Location

BRA002

Itajaí, 88301-220, Brazil

Location

BRA001

Porto Alegre, 91350-200, Brazil

Location

BR008

Salvador, 40170-150, Brazil

Location

BRA003

São Paulo, 01246-000, Brazil

Location

BRA006

São Paulo, 01323-903, Brazil

Location

BRA007

São Paulo, 04032-060, Brazil

Location

DNK005

Copenhagen, 2400, Denmark

Location

DNK004

Glostrup Municipality, 2600, Denmark

Location

DNK001

Odense, Denmark

Location

FRA004

Amiens, France

Location

FRA002

Bordeaux, France

Location

FRA001

Boulogne-Billancourt, France

Location

FRA003

Le Chesnay, France

Location

FRA005

Lille, France

Location

FRA010

Montauban, France

Location

FRA006

Nantes, 44093, France

Location

FRA009

Paris, 75004, France

Location

FRA008

Saint-Priest-en-Jarez, 42270, France

Location

FR007

Toulouse, 31059, France

Location

ITA004

Florence, Italy

Location

ITA003

Napoli, Italy

Location

ITA001

Rome, Italy

Location

ESP001

Barcelona, Spain

Location

ESP002

Barcelona, Spain

Location

ESP006

Madrid, 28041, Spain

Location

ESP005

Madrid, Spain

Location

GBR003

Cardiff, CF14 4XW, United Kingdom

Location

GBR001

Glasgow, G12 0YN, United Kingdom

Location

GBR004

Liverpool, L9 7LJ, United Kingdom

Location

GBR002

Manchester, M23 9LT, United Kingdom

Location

Related Publications (1)

• Palladini M, Boesl I, Koenig S, Buchheister B, Attal N. Lidocaine medicated plaster, an additional potential treatment option for localized post-surgical neuropathic pain: efficacy and safety results of a randomized, placebo-controlled trial. Curr Med Res Opin. 2019 May;35(5):757-766. doi: 10.1080/03007995.2019.1565709. Epub 2019 Jan 21.

  PMID: 30614286 DERIVED

MeSH Terms

Conditions

Pain; Chronic Pain; Neuralgia; Pain, Postoperative

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Study Director

  Grünenthal GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2012
• First Posted: December 19, 2012
• Study Start: October 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: July 6, 2016

Record last verified: 2016-07

Locations

BE (5); AU (6); DK (3); BR (7); FR (10); IT (3); ES (4); GB (4)