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Lidocaine 5% Medicated Plaster in Chronic Neuropathic Postoperative Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01155986
Recruitment Status : Terminated (Trial was stopped due to difficult enrolment)
First Posted : July 2, 2010
Last Update Posted : March 17, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pain Chronic Pain Neuropathic Pain Postoperative Pain Drug: Lidocaine 5% medicated plaster Drug: Placebo topical plaster Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lidocaine 5% Medicated Plaster for the Topical Treatment of Localized Chronic Postoperative Neuropathic Pain.
Study Start Date : August 2010
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo Plaster
Active Comparator
Drug: Placebo topical plaster
Topical hydrogel plaster

Active Comparator: Lidocaine Plaster Drug: Lidocaine 5% medicated plaster
Topical hydrogel plaster (700mg lidocaine)
Other Name: Versatis(R)

Primary Outcome Measures :
  1. Assess the analgesic efficacy of lidocaine 5% medicated plaster in comparison to placebo in subjects with moderate to severe localized chronic postoperative neuropathic pain [ Time Frame: daily ]

    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.)

    Efficacy of the treatment (i.e., reduction of neuropathic pain) will be evaluated with the 11-point numeric rating scale (NRS).

Secondary Outcome Measures :
  1. To evaluate the effect of lidocaine 5% medicated plaster on quality of life. [ Time Frame: 4 weeks ]
    EuroQol-5 Dimension Scores

  2. Neuropathic Pain Symptoms [ Time Frame: 4 weeks ]
    Changes in severity of various neuropathic pain symptoms, e.g. allodynia, will be recorded by the Neuropathic Pain Symptom Inventory (NPSI) and neurological examinations

  3. Safety [ Time Frame: up to 44 days ]
    Measurement of adverse events including laboratory data

  4. Hospital Anxiety and Depression Scale [ Time Frame: 4 weeks ]
  5. Subject's Global Impression of Change [ Time Frame: 4 weeks ]
  6. Treatment Satisfaction Questionnaire for Medication [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01155986

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Site 31
Abbeville, France
Site 26
Bayonne, France
Site 34
Bobigny, France
Site 35
Bordeaux, France
Site 12
Boulogne-Billancourt, France
Site 24
Brest, France
Site 15
Chateauroux, France
Site 30
Corbeil Essonnes, France
Site 39
La Roche Sur Yon, France
Site 23
Lille cedex, France
Site 17
Limoges, France
Site 21
Marseille, France
Site 33
Montauban, France
Site 14
Nice Cedex 1, France
Site 18
Orleans, France
Site 27
Paris, France
Site 36
Paris, France
Site 22
Rennes Cedex, France
Site 19
Saint Genis Laval, France
Site 20
Saint-Etienne cedex 2, France
Site 38
Tours, France
Site 28
Voiron, France
Sponsors and Collaborators
Grünenthal GmbH
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Principal Investigator: Jean Bruxelle Fondation Ophtalmologique Adolphe de Rotschild, Service de Neurochirurgie, CEntre d'Evaluation et de Traitement de la Douleur

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Responsible Party: Grünenthal GmbH Identifier: NCT01155986     History of Changes
Other Study ID Numbers: 761541
2009 016337 10 ( EudraCT Number )
First Posted: July 2, 2010    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: March 2015
Keywords provided by Grünenthal GmbH:
chronic pain
localized pain
focal pain
neuropathic pain
postoperative pain
topical analgesia
Additional relevant MeSH terms:
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Neuromuscular Diseases
Pain, Postoperative
Chronic Pain
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms
Peripheral Nervous System Diseases
Nervous System Diseases
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action