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Lidocaine 5% Medicated Plaster in Chronic Neuropathic Postoperative Pain

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ClinicalTrials.gov Identifier: NCT01155986
Recruitment Status : Terminated (Trial was stopped due to difficult enrolment)
First Posted : July 2, 2010
Last Update Posted : October 16, 2019
Sponsor:
Information provided by (Responsible Party):
Grünenthal GmbH

Tracking Information
First Submitted Date  ICMJE July 1, 2010
First Posted Date  ICMJE July 2, 2010
Last Update Posted Date October 16, 2019
Study Start Date  ICMJE August 2010
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2019)
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 assessments over 4 weeks ]
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).
Original Primary Outcome Measures  ICMJE
 (submitted: July 1, 2010)
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).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2019)
  • Effect of lidocaine 5% medicated plaster on quality of life [ Time Frame: 4 weeks ]
    EuroQol-5 Dimension Scores
  • 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
  • Incidence of adverse events [ Time Frame: up to 44 days ]
    Measurement of adverse events including those derived from laboratory data or vital signs measurements.
  • Hospital Anxiety and Depression Scale [ Time Frame: 4 weeks ]
  • Subject's Global Impression of Change [ Time Frame: 4 weeks ]
  • Treatment Satisfaction Questionnaire for Medication [ Time Frame: 4 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2010)
  • To evaluate the effect of lidocaine 5% medicated plaster on quality of life. [ Time Frame: 4 weeks ]
    EuroQol-5 Dimension Scores
  • 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
  • Safety [ Time Frame: up to 44 days ]
    Measurement of adverse events including laboratory data
  • Hospital Anxiety and Depression Scale [ Time Frame: 4 weeks ]
  • Subject's Global Impression of Change [ Time Frame: 4 weeks ]
  • Treatment Satisfaction Questionnaire for Medication [ Time Frame: 4 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lidocaine 5% Medicated Plaster in Chronic Neuropathic Postoperative Pain
Official Title  ICMJE Lidocaine 5% Medicated Plaster for the Topical Treatment of Localized Chronic Postoperative Neuropathic Pain.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Pain
  • Chronic Pain
  • Neuropathic Pain
  • Postoperative Pain
Intervention  ICMJE
  • Drug: Lidocaine 5% medicated plaster
    Topical hydrogel plaster (700mg lidocaine)
    Other Name: Versatis(R)
  • Drug: Placebo topical plaster
    Topical hydrogel plaster
Study Arms  ICMJE
  • Placebo Comparator: Placebo Plaster
    Active Comparator
    Intervention: Drug: Placebo topical plaster
  • Active Comparator: Lidocaine Plaster
    Intervention: Drug: Lidocaine 5% medicated plaster
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 12, 2012)
74
Original Estimated Enrollment  ICMJE
 (submitted: July 1, 2010)
130
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01155986
Other Study ID Numbers  ICMJE 761541
2009-016337-10 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Grünenthal GmbH
Study Sponsor  ICMJE Grünenthal GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jean Bruxelle Fondation Ophtalmologique Adolphe de Rotschild, Service de Neurochirurgie, CEntre d'Evaluation et de Traitement de la Douleur
PRS Account Grünenthal GmbH
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP