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Lidocaine 5% Plasters (Versatis® 5%) in Pediatric Neuropathic Pains and Vasoocclusive Sickle Cell Crisis Pains

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ClinicalTrials.gov Identifier: NCT01314300
Recruitment Status : Completed
First Posted : March 14, 2011
Last Update Posted : October 30, 2014
Sponsor:
Information provided by (Responsible Party):
Centre Leon Berard

Tracking Information
First Submitted Date  ICMJE March 11, 2011
First Posted Date  ICMJE March 14, 2011
Last Update Posted Date October 30, 2014
Study Start Date  ICMJE March 2011
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2011)
Lidocaine 5% plaster efficacy between t0 and t12 [ Time Frame: 12 hours ]
Rate of patients with a decrease of at least 2 points in pain score (at least 2 of 3 consecutive days) measured by self-assessment on a visual analogue scale (VAS) graded from 0 to 10 (0 = absence pain and 10 = maximal pain ), between start of treatment(t0) and a measure carried out 12 hours later (t12).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2011)
  • Lidocaine 5% plaster efficacy between t0 and t6 [ Time Frame: 6 hours ]
    Rate of patients with a decrease of at least 2 points in pain score (at least 2 of 3 consecutive days) measured by self-assessment on a visual analogue scale (VAS) graded from 0 to 10 (0 = absence pain and 10 = maximal pain ), between start of treatment(t0) and a measure carried out 6 hours later (t6).
  • Lidocaine 5% plaster safety [ Time Frame: 72 hours ]
    Rate of patients with local and/or general adverse event as graded using NCI-CTCAE V4.0
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lidocaine 5% Plasters (Versatis® 5%) in Pediatric Neuropathic Pains and Vasoocclusive Sickle Cell Crisis Pains
Official Title  ICMJE VERSATIS - Efficacy and Safety of Lidocaine 5% Plasters (Versatis® 5%) in Child, Adolescents and Young Adults With Neuropathic Pains or Vasoocclusive Sickle Cell Crisis Pains
Brief Summary

Lidocaine 5% plaster (VERSATIS® 5%) showed its efficacy and safety in the post-herpetic zoster adult pains. This treatment is recommended in first intention in adult neuropathic pains with allodynia.

The purpose of this study is to assess efficacy and safety of lidocaine 5% plaster (VERSATIS® 5%) in the pediatric neuropathic pains and vasoocclusive sickle cell crises pains.

Detailed Description

Pediatric neuropathic pain are infrequent. It's difficult to estimate the prevalence. It may result from several causes : infectious (post-herpetic neuropathy), traumatic (tumor or Positional)or toxic (chemotherapy or radiotherapy). They are often associated with malignant pediatric disease.

These pains are spontaneous, continuous or intermittent, as type of burns or electric shocks or abnormal skin sensation (hyperesthesia or allodynia). Treatment is the same as in adults: antiepileptic or neuroleptics, sometimes associated with analgesic (level 2 or 3).

Lidocaine 5% plaster are used in adults as first line of treatment to reduce post-herpetic neuropathic pain, especially in cases of mechanical allodynia. These plasters are indicated for the symptomatic treatment of post-herpetic neuropathic pain.

Each plaster contains 700 mg of lidocaine. It must be applied on the painful area once daily for a maximum period of 12 hours per 24 hours.

The primary endpoint is to evaluate the efficacy of lidocaine 5% plaster (VERSATIS 5%) after 12 hours on reducing of pure or mixed neuropathic pain and on reducing of vasoocclusive sickle cell pain, localized, superficial, in child, adolescent and young adult.

The secondary endpoint are:

  1. to evaluate the efficacy of lidocaine 5% plaster (VERSATIS 5%) after 6 hours on reducing of pure or mixed neuropathic pain and on reducing of vasoocclusive sickle cell pain, localized, superficial, in child, adolescent and young adult.
  2. to evaluate safety of lidocaine 5% plaster (VERSATIS® 5%) in these same indications.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Neuropathic Pains
  • Vasoocclusive Sickle Cell Crises Pains
Intervention  ICMJE Drug: Lidocaine
Lidocaine 5% plaster
Other Name: Versatis® 5%
Study Arms  ICMJE Experimental: Efficacy of Lidocaine 5% plaster
Treatment of pain by Lidocaine 5% plaster
Intervention: Drug: Lidocaine
Publications *

*   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 Completed
Estimated Enrollment  ICMJE
 (submitted: March 11, 2011)
39
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 6 years <= Age <= 21 years
  • With:

    • Pure or mixed, localized, superficial neuropathic pains for which the neuropathic pain score DN4 is greater than or equal to 4
    • Or localized, superficial sickle cell crisis pains Insufficiently relieved by commonly used therapeutic (analgesic level II or III and / or antiepileptic drugs, and / or neuroleptics) - GCS > 12
  • Covered by a medical insurance
  • Signed written informed consent form(for minors unemancipated, permission will be given by holders of parental authority)

Exclusion Criteria:

  • Clinical condition not permitting data reporting (impaired consciousness)
  • Painful area with an surface greater than:

    • 150 cm² for a patient with total body surface area < 1 m²
    • 300 cm² for a patient with 1 m² < total body surface area < 1.5 m²
    • 450 cm² for a patient with total body surface area > 1.5 m²
  • Existence of a statement for the use of lidocaine 5% (VERSATIS® 5%) plaster as defined in the summary of product characteristics, as:

    • known hypersensitivity to the active substance or excipients
    • known hypersensitivity to other local anesthetics such as amide (eg bupivacaine, etidocaine, mepivacaine and prilocaine)
    • inflammatory or injured skin (active lesions of herpes zoster, dermatitis or wounds)
  • Severe cardiac insufficiency
  • Severe renal insufficiency
  • Severe hepatic insufficiency
  • Patient receiving anti-arrhythmic class I or other local anesthetics.
  • Pregnant or lactating female or female of child-bearing potential not employing adequate contraception
  • Patient included in another clinical trial on the management of pain
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 21 Years   (Child, 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 NCT01314300
Other Study ID Numbers  ICMJE VERSATIS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Leon Berard
Study Sponsor  ICMJE Centre Leon Berard
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Perrine MAREC-BERARD, M.D. IHOP
PRS Account Centre Leon Berard
Verification Date October 2014

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