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

This study is currently recruiting participants.
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

March 11, 2011
January 30, 2014
March 2011
June 2014   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01314300 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Lidocaine 5% Plasters (Versatis® 5%) in Pediatric Neuropathic Pains and Vasoocclusive Sickle Cell Crisis Pains
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

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.

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.
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Neuropathic Pains
  • Vasoocclusive Sickle Cell Crises Pains
Drug: Lidocaine
Lidocaine 5% plaster
Other Name: Versatis® 5%
Experimental: Efficacy of Lidocaine 5% plaster
Treatment of pain by Lidocaine 5% plaster
Intervention: Drug: Lidocaine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
39
December 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
6 Years to 21 Years
No
Contact: Séverine METZGER +33 4 78 78 27 86 severine.metzger@lyon.unicancer.fr
Contact: Leila BEN ABDESSELEM leila.benabdesselem@lyon.unicancer.fr
France
 
NCT01314300
VERSATIS
No
Centre Leon Berard
Centre Leon Berard
Not Provided
Principal Investigator: Perrine MAREC-BERARD, M.D. IHOP
Centre Leon Berard
January 2014

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