Lidocaine 5% Medicated Plaster in Chronic Neuropathic Postoperative Pain

This study has been terminated.
(Trial was stopped due to difficult enrolment)
Sponsor:
Information provided by (Responsible Party):
Grünenthal GmbH
ClinicalTrials.gov Identifier:
NCT01155986
First received: July 1, 2010
Last updated: December 12, 2012
Last verified: December 2012
  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 topical plaster
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lidocaine 5% Medicated Plaster for the Topical Treatment of Localized Chronic Postoperative Neuropathic Pain.

Resource links provided by NLM:


Further study details as provided by Grünenthal GmbH:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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:
  • To evaluate the effect of lidocaine 5% medicated plaster on quality of life. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    EuroQol-5 Dimension Scores

  • Neuropathic Pain Symptoms [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Changes in severity of various neuropathic pain symptoms, e.g. allodynia, will be recorded by the Neuropathic Pain Symptom Inventory (NPSI) and neurological examinations

  • Safety [ Time Frame: up to 44 days ] [ Designated as safety issue: Yes ]
    Measurement of adverse events including laboratory data

  • Hospital Anxiety and Depression Scale [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Subject's Global Impression of Change [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Treatment Satisfaction Questionnaire for Medication [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 74
Study Start Date: August 2010
Estimated Study Completion Date: January 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01155986

Locations
France
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
Investigators
Principal Investigator: Jean Bruxelle Fondation Ophtalmologique Adolphe de Rotschild, Service de Neurochirurgie, CEntre d'Evaluation et de Traitement de la Douleur
  More Information

No publications provided

Responsible Party: Grünenthal GmbH
ClinicalTrials.gov Identifier: NCT01155986     History of Changes
Other Study ID Numbers: 761541, 2009 016337 10
Study First Received: July 1, 2010
Last Updated: December 12, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Grünenthal GmbH:
analgesic
analgesics
pain
chronic pain
localized pain
focal pain
neuropathic pain
postoperative pain
topical analgesia

Additional relevant MeSH terms:
Neuralgia
Pain, Postoperative
Chronic Pain
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
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014