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Lidocaine 5% Medicated Plaster in Chronic Neuropathic Postoperative Pain

Primary Purpose

Pain, Chronic Pain, Neuropathic Pain

Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Lidocaine 5% medicated plaster
Placebo topical plaster
Sponsored by
Grünenthal GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring analgesic, analgesics, pain, chronic pain, localized pain, focal pain, neuropathic pain, postoperative pain, topical analgesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female subjects with >= 18 years of age
  • Intact skin in the area of topical treatment
  • Patients suffering from moderate to severe ( 5 or more points on an 11 point Numerical Rating Scale where 10 is the worst possible pain, and 0 indicates no pain) chronic daily postoperative neuropathic pain for the past 6 to 24 months.
  • Patients should have symptoms for example allodynia (a pain due to a stimulus which does not normally provoke pain); and or dysesthesia (unpleasant, abnormal sense of touch).

Exclusion Criteria:

  • Contraindications to lidocaine 5% medicated plaster, or paracetamol
  • Evidence or history of alcohol, medication or drug abuse and/or dependency in the past 3 years.
  • Evidence or history (during the past 3 years) of epilepsy, neurotic personality, psychiatric illness, or suicide risk.
  • Pregnant or breastfeeding women
  • Women of childbearing potential who are sexually active without satisfactory contraception for at least 28 days prior to enrollment, during the trial, and until 28 days after the follow-up visit.
  • Severe renal, hepatic or heart disorder.
  • Surgery in the past 3 months before screening.
  • Anticipated need for surgery during the trial, requiring at least regional or general anesthesia.
  • Pending litigation due to chronic pain or disability.
  • Participation in another trial of investigational medicinal products or devices parallel to or less than 1 month before entry into the trial, or previous participation in this trial.
  • Presence of other severe pain that could confound the assessment or self- evaluation of the localized postoperative neuropathic pain.
  • For patients with chronic postoperative neuropathic pain related to a surgery due to tumors: suspected residual tumor or metastases, chemotherapy or radiotherapy for treatment of tumor(s).
  • Total anesthesia in the area of localized chronic pain

Sites / Locations

  • Site 31
  • Site 26
  • Site 34
  • Site 35
  • Site 12
  • Site 24
  • Site 15
  • Site 30
  • Site 39
  • Site 23
  • Site 17
  • Site 21
  • Site 33
  • Site 14
  • Site 18
  • Site 27
  • Site 36
  • Site 22
  • Site 19
  • Site 20
  • Site 38
  • Site 28

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo Plaster

Lidocaine Plaster

Arm Description

Active Comparator

Outcomes

Primary Outcome Measures

Analgesic efficacy of lidocaine 5% medicated plaster in comparison to placebo in subjects with moderate to severe localized chronic postoperative neuropathic pain
Participants will be selected based on their medical history and clinical examination. A questionnaire called DN4, which stands for 'douleur neuropathique 4' (i.e., '4 questions neuropathic pain will be used to identify subjects with neuropathic pain.) Pain will be assessed on and 11-point numerical rating scale (0 = no pain, 10 = worst pain imaginable). Efficacy of the treatment (i.e., reduction of neuropathic pain) will be evaluated with the 11-point numeric rating scale (NRS).

Secondary Outcome Measures

Effect of lidocaine 5% medicated plaster on quality of life
EuroQol-5 Dimension Scores
Neuropathic Pain Symptoms
Changes in severity of various neuropathic pain symptoms, e.g. allodynia, will be recorded by the Neuropathic Pain Symptom Inventory (NPSI) and neurological examinations
Incidence of adverse events
Measurement of adverse events including those derived from laboratory data or vital signs measurements.
Hospital Anxiety and Depression Scale
Subject's Global Impression of Change
Treatment Satisfaction Questionnaire for Medication

Full Information

First Posted
July 1, 2010
Last Updated
October 14, 2019
Sponsor
Grünenthal GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01155986
Brief Title
Lidocaine 5% Medicated Plaster in Chronic Neuropathic Postoperative Pain
Official Title
Lidocaine 5% Medicated Plaster for the Topical Treatment of Localized Chronic Postoperative Neuropathic Pain.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Terminated
Why Stopped
Trial was stopped due to difficult enrolment
Study Start Date
August 2010 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Grünenthal GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
Some patients who undergo different types of surgery develop distressing and long-lasting pain. This pain is often characterized by signs such as: allodynia (a pain due to a stimulus which does not normally provoke pain), dysesthesia (unpleasant, abnormal sense of touch). Patients describe symptoms of burning or electrical type sensation. In some cases this type of chronic pain can still be present after 3 months or more following surgery.This clinical trial will assess the efficacy and safety profile of lidocaine 5% medicated plaster in comparison to placebo plaster in patients. This trial is a randomized, double-blind (neither investigator nor patient will know which treatment was received), placebo-controlled, parallel-group, multicenter trial to evaluate topical analgesic treatment of chronic neuropathic pain after surgery. The trial will include a screening phase and a treatment phase, during which subjects will be treated with either 5% lidocaine medicated plaster, or a placebo plaster pain intensity will be assessed on a daily basis. Subsequently there will be a follow-up phase. Pain intensity numeric rating scale (PI) will be collected via the numeric rating scale and averaged. Safety evaluations include monitoring of adverse events, physical examinations, and clinical laboratory tests.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic Pain, Neuropathic Pain, Postoperative Pain
Keywords
analgesic, analgesics, pain, chronic pain, localized pain, focal pain, neuropathic pain, postoperative pain, topical analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo Plaster
Arm Type
Placebo Comparator
Arm Description
Active Comparator
Arm Title
Lidocaine Plaster
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Lidocaine 5% medicated plaster
Other Intervention Name(s)
Versatis(R)
Intervention Description
Topical hydrogel plaster (700mg lidocaine)
Intervention Type
Drug
Intervention Name(s)
Placebo topical plaster
Intervention Description
Topical hydrogel plaster
Primary Outcome Measure Information:
Title
Analgesic efficacy of lidocaine 5% medicated plaster in comparison to placebo in subjects with moderate to severe localized chronic postoperative neuropathic pain
Description
Participants will be selected based on their medical history and clinical examination. A questionnaire called DN4, which stands for 'douleur neuropathique 4' (i.e., '4 questions neuropathic pain will be used to identify subjects with neuropathic pain.) Pain will be assessed on and 11-point numerical rating scale (0 = no pain, 10 = worst pain imaginable). Efficacy of the treatment (i.e., reduction of neuropathic pain) will be evaluated with the 11-point numeric rating scale (NRS).
Time Frame
daily assessments over 4 weeks
Secondary Outcome Measure Information:
Title
Effect of lidocaine 5% medicated plaster on quality of life
Description
EuroQol-5 Dimension Scores
Time Frame
4 weeks
Title
Neuropathic Pain Symptoms
Description
Changes in severity of various neuropathic pain symptoms, e.g. allodynia, will be recorded by the Neuropathic Pain Symptom Inventory (NPSI) and neurological examinations
Time Frame
4 weeks
Title
Incidence of adverse events
Description
Measurement of adverse events including those derived from laboratory data or vital signs measurements.
Time Frame
up to 44 days
Title
Hospital Anxiety and Depression Scale
Time Frame
4 weeks
Title
Subject's Global Impression of Change
Time Frame
4 weeks
Title
Treatment Satisfaction Questionnaire for Medication
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female subjects with >= 18 years of age Intact skin in the area of topical treatment Patients suffering from moderate to severe ( 5 or more points on an 11 point Numerical Rating Scale where 10 is the worst possible pain, and 0 indicates no pain) chronic daily postoperative neuropathic pain for the past 6 to 24 months. Patients should have symptoms for example allodynia (a pain due to a stimulus which does not normally provoke pain); and or dysesthesia (unpleasant, abnormal sense of touch). Exclusion Criteria: Contraindications to lidocaine 5% medicated plaster, or paracetamol Evidence or history of alcohol, medication or drug abuse and/or dependency in the past 3 years. Evidence or history (during the past 3 years) of epilepsy, neurotic personality, psychiatric illness, or suicide risk. Pregnant or breastfeeding women Women of childbearing potential who are sexually active without satisfactory contraception for at least 28 days prior to enrollment, during the trial, and until 28 days after the follow-up visit. Severe renal, hepatic or heart disorder. Surgery in the past 3 months before screening. Anticipated need for surgery during the trial, requiring at least regional or general anesthesia. Pending litigation due to chronic pain or disability. Participation in another trial of investigational medicinal products or devices parallel to or less than 1 month before entry into the trial, or previous participation in this trial. Presence of other severe pain that could confound the assessment or self- evaluation of the localized postoperative neuropathic pain. For patients with chronic postoperative neuropathic pain related to a surgery due to tumors: suspected residual tumor or metastases, chemotherapy or radiotherapy for treatment of tumor(s). Total anesthesia in the area of localized chronic pain
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Bruxelle
Organizational Affiliation
Fondation Ophtalmologique Adolphe de Rotschild, Service de Neurochirurgie, CEntre d'Evaluation et de Traitement de la Douleur
Official's Role
Principal Investigator
Facility Information:
Facility Name
Site 31
City
Abbeville
Country
France
Facility Name
Site 26
City
Bayonne
Country
France
Facility Name
Site 34
City
Bobigny
Country
France
Facility Name
Site 35
City
Bordeaux
Country
France
Facility Name
Site 12
City
Boulogne-Billancourt
Country
France
Facility Name
Site 24
City
Brest
Country
France
Facility Name
Site 15
City
Chateauroux
Country
France
Facility Name
Site 30
City
Corbeil Essonnes
Country
France
Facility Name
Site 39
City
La Roche Sur Yon
Country
France
Facility Name
Site 23
City
Lille cedex
Country
France
Facility Name
Site 17
City
Limoges
Country
France
Facility Name
Site 21
City
Marseille
Country
France
Facility Name
Site 33
City
Montauban
Country
France
Facility Name
Site 14
City
Nice Cedex 1
Country
France
Facility Name
Site 18
City
Orleans
Country
France
Facility Name
Site 27
City
Paris
Country
France
Facility Name
Site 36
City
Paris
Country
France
Facility Name
Site 22
City
Rennes Cedex
Country
France
Facility Name
Site 19
City
Saint Genis Laval
Country
France
Facility Name
Site 20
City
Saint-Etienne cedex 2
Country
France
Facility Name
Site 38
City
Tours
Country
France
Facility Name
Site 28
City
Voiron
Country
France

12. IPD Sharing Statement

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Lidocaine 5% Medicated Plaster in Chronic Neuropathic Postoperative Pain

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