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

July 5, 2016 updated by: Grünenthal GmbH

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
444

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Klagenfurt, Austria
        • AUT004
      • Senftenberg, Austria
        • AUT005
      • Vienna, Austria, 1100
        • AUT006
      • Vienna, Austria
        • AUT002
      • Vienna, Austria
        • AUT003
      • Wien, Austria, 1090
        • AUT001
  • Belgium
      • Gozée, Belgium
        • BEL001
      • Halen, Belgium, 3545
        • BEL006
      • Ham, Belgium
        • BEL004
      • Lanaken, Belgium, 3620
        • BEL007
      • Natoye, Belgium
        • BEL002
  • Brazil
      • Barretos, Brazil, 14784-400
        • BRA005
      • Itajai, Brazil, 88301-220
        • BRA002
      • Porto Alegre, Brazil, 91350-200
        • BRA001
      • Salvador, Brazil, 40170-150
        • BR008
      • Sao Paulo, Brazil, 01246-000
        • BRA003
      • São Paulo, Brazil, 01323-903
        • BRA006
      • São Paulo, Brazil, 04032-060
        • BRA007
  • Denmark
      • Copenhagen, Denmark, 2400
        • DNK005
      • Glostrup, Denmark, 2600
        • DNK004
      • Odense, Denmark
        • DNK001
  • France
      • Amiens, France
        • FRA004
      • Bordeaux, France
        • FRA002
      • Boulogne Billancourt, France
        • FRA001
      • Le Chesnay, France
        • FRA003
      • Lille, France
        • FRA005
      • Montauban, France
        • FRA010
      • Nantes, France, 44093
        • FRA006
      • Paris, France, 75004
        • FRA009
      • Saint-Priest en Jarez, France, 42270
        • FRA008
      • Toulouse, France, 31059
        • FR007
  • Italy
      • Firenze, Italy
        • ITA004
      • Napoli, Italy
        • ITA003
      • Rome, Italy
        • ITA001
  • Spain
      • Barcelona, Spain
        • ESP001
      • Barcelona, Spain
        • ESP002
      • Madrid, Spain, 28041
        • ESP006
      • Madrid, Spain
        • ESP005
  • United Kingdom
      • Cardiff, United Kingdom, CF14 4XW
        • GBR003
      • Glasgow, United Kingdom, G12 0YN
        • GBR001
      • Liverpool, United Kingdom, L9 7LJ
        • GBR004
      • Manchester, United Kingdom, M23 9LT
        • GBR002

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Lidocaine plaster
Topical hydrogel plaster
Drug: Lidocaine 5% medicated plaster
Placebo Comparator: Placebo plaster
Topical hydrogel plaster
Drug: Placebo plaster

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Days 78-85

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
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.
Time Frame: up to 12 weeks
up to 12 weeks
Weekly mean pain intensity before plaster removal based on the average pain intensity during the last 24 hours.
Time Frame: up to 12 weeks
up to 12 weeks
Weekly mean pain intensity before plaster removal based on current pain intensity before plaster removal.
Time Frame: up to 12 weeks
up to 12 weeks
Final score of the painDETECT Pain Questionnaire during the Double blind Treatment Period.
Time Frame: Day 85
Day 85
Pain intensity from mechanical dynamic allodynia (brush) testing.
Time Frame: Day 85
Day 85
Anxiety and depression scores of HADS.
Time Frame: Day 85
Day 85
The weighted Health Status Index of quality of life by means of EQ 5D.
Time Frame: Day 85
Day 85
Total score in quality of sleep using CPSI.
Time Frame: Day 85
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.
Time Frame: up to 12 weeks
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.
Time Frame: up to 12 weeks
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.
Time Frame: up to 12 weeks
up to 12 weeks
Weekly mean pain intensity change from baseline before plaster removal based on current pain intensity before plaster removal.
Time Frame: up to 12 weeks
up to 12 weeks
Change from baseline in the total score of the painDETECT Pain Questionnaire during the Double blind Treatment Period.
Time Frame: Day 85
Day 85
Change from baseline in pain intensity from mechanical dynamic allodynia (brush) testing.
Time Frame: Day 85
Day 85
Change from baseline in anxiety and depression scores of HADS.
Time Frame: Day 85
Day 85
Change from baseline in total score of quality of life by means of EQ 5D.
Time Frame: Day 85
Day 85
Change from baseline in total score in quality of sleep using CPSI.
Time Frame: Day 85
Day 85

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Grünenthal GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 12, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 6, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KF10004/10
  • 2012-000347-28 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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