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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Centre Leon Berard
Sponsor:
Information provided by (Responsible Party):
Centre Leon Berard
ClinicalTrials.gov Identifier:
NCT01314300
First received: March 11, 2011
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Neuropathic Pains
Vasoocclusive Sickle Cell Crises Pains
Drug: Lidocaine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Centre Leon Berard:

Primary Outcome Measures:
  • Lidocaine 5% plaster efficacy between t0 and t12 [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Lidocaine 5% plaster efficacy between t0 and t6 [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Rate of patients with local and/or general adverse event as graded using NCI-CTCAE V4.0


Estimated Enrollment: 39
Study Start Date: March 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Efficacy of Lidocaine 5% plaster
Treatment of pain by Lidocaine 5% plaster
Drug: Lidocaine
Lidocaine 5% plaster
Other Name: Versatis® 5%

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.
  Eligibility

Ages Eligible for Study:   6 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01314300

Contacts
Contact: Séverine METZGER +33 4 78 78 27 86 severine.metzger@lyon.unicancer.fr
Contact: Leila BEN ABDESSELEM leila.benabdesselem@lyon.unicancer.fr

Locations
France
IHOP Recruiting
Lyon, France, 69008
Contact: Perrine MAREC-BERARD, M.D.         
Principal Investigator: Perrine MAREC-BERARD, M.D.         
Centre Médico-chirurgical de Réadaptation des Massues Active, not recruiting
Lyon, France
Sponsors and Collaborators
Centre Leon Berard
Investigators
Principal Investigator: Perrine MAREC-BERARD, M.D. IHOP
  More Information

Publications:
Responsible Party: Centre Leon Berard
ClinicalTrials.gov Identifier: NCT01314300     History of Changes
Other Study ID Numbers: VERSATIS
Study First Received: March 11, 2011
Last Updated: January 30, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Leon Berard:
Child, adolescent, young adult
Plaster
Lidocaine

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
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

ClinicalTrials.gov processed this record on July 24, 2014