Clinical Trial Results:
VERSATIS - Efficacité et tolérance d’emplâtres de lidocaïne à 5% (Versatis® 5%) dans les douleurs neuropathiques et dans les douleurs de crises vaso-occlusives drépanocytaires de l’enfant, de l’adolescent et du jeune adulte
VERSATIS - Lidocaïne 5% plasters (Versatis® 5%) in pediatric neuropathics pains and vasoocclusive sickle cell crisis pain
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Summary
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EudraCT number |
2010-023461-22 |
Trial protocol |
FR |
Global end of trial date |
27 Mar 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
13 Mar 2021
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First version publication date |
13 Mar 2021
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Other versions |
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Summary report(s) |
Publication Versatis |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
ET2010-077
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01314300 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Centre Léon Bérard
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Sponsor organisation address |
28 rue Laennec, LYON, France, 69008
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Public contact |
Centre Léon Bérard, Centre Léon Bérard, 33 478782968, DRCIreglementaire@lyon.unicancer.fr
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Scientific contact |
Dr Perrine MAREC-BERARD, Dr Perrine MAREC-BERARD, 33 478782828, DRCIreglementaire@lyon.unicancer.fr
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
15 Dec 2014
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
26 Mar 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
27 Mar 2014
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Estimer l’efficacité à 12 heures de Versatis® 5% sur la réduction des douleurs neuropathiques pures ou mixtes et sur la réduction des douleurs de crises vaso-occlusives drépanocytaires, localisées, superficielles, chez l’enfant, l’adolescent et le jeune adulte
Proportion of patients with a significant pain score decrease i.e. difference in VAS pain score of at least two points between t0 and t12 (12h-VAS ≥2p-decrease) during at least two out of the three consecutive days of treatment.
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Protection of trial subjects |
Within the framework of this study, the patients included will be followed according to the recommendations for the management of pain. The pain score was assessed by a 100 mm-Visual Analogue Score (VAS) self-assessment graduated from 0 (no pain) to 10 (maximal pain) at patch application (t0), at 6 hours (t6), and at 12 hours (t12) post application during three consecutive days. The analgesic treatments prescribed before the inclusion was not changed during the three days of evaluation unless absolutely required. In case of significant increase in pain during the three days (i.e. at least two points increasing in VAS score), the use of additional level II or level III analgesics, antiepileptics, or antidepressants was allowed and collected.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
05 Jul 2011
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
France: 39
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Worldwide total number of subjects |
39
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EEA total number of subjects |
39
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
13
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Adolescents (12-17 years) |
13
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Adults (18-64 years) |
13
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
France 1st inclusion : 05/07/2011 Last patient last visit : 27/03/2014 | ||||||
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Pre-assignment
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Screening details |
Children and young adults aged from 6 to 21 years old suffering from either neuropathic pain in an oncologic setting, or localized and superficial pain due to vaso-occlusive bone crises in sickle-cell patients, insufficiently relieved by the commonly used treatments were eligible. The DN4 score had to be ≥4. | ||||||
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Period 1
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Period 1 title |
Treatment (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||
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Arms
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Arm title
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Experimental | ||||||
Arm description |
Efficacy of lidocaine 5% plaster Treatment of pain by lidocaine 5% plaster | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Lidocaïne 5% plaster
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Cutaneous patch
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Routes of administration |
Cutaneous use
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Dosage and administration details |
The lidocaine 5% patches (Versatis®, Grünenthal GmbH, Aachen, Germany) for cutaneous application consists of a hydrogel base stuck to a polyethylene terephthalate support covered with a protective film of polyethylene terephthalate.22 Each plaster, supplied in 10 by 14cm size and containing 700 mg of lidocaine, was applied to the painful area (the most painful one in case of several painful areas) for 12 hours per day (12 hours application then 12 hours without patch), and for at least three consecutive days. The patch was applied on intact skin, not irritated, not injured, to more thoroughly cover the painful area with the number of patches defined according to the size of the painful area and the patient's body surface
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Baseline characteristics reporting groups
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Reporting group title |
Treatment
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Experimental
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Reporting group description |
Efficacy of lidocaine 5% plaster Treatment of pain by lidocaine 5% plaster | ||
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End point title |
Pain score [1] | ||||||
End point description |
Proportion of patients with a significant pain score decrease i.e. difference in VAS pain score of at least two points between t0 and t12 (12h-VAS ≥2p-decrease) during at least two out of the three consecutive days of treatment
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End point type |
Primary
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End point timeframe |
12 hours
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No possibility of size the type of statistical analyse : the sample size was calculated using the Fleming-A'hern single-stage design23 assuming that the proportion of patients with a 12h-VAS ≥2p-decrease during at least two of the three consecutive days following patch application should result in at least 60%. A rate of 60% or less would mean that the benefit in pain relief is not confirmed. Assuming a 5% one-sided alpha and 85% power, 39 patients had to be enrolled. A minimum of 29 successes w |
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| No statistical analyses for this end point | |||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
The investigator collects (spontaneous patient report or questionning) and immediately notifies the sponsor of all SAEs, in a written report, wether or not theay are deemed to be attributable to research and wich occur during the study
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Adverse event reporting additional description |
3 (7.7%, 95%CI [1.6%-20.9%]) patients experienced at least one grade 1 or 2 adverse event with only two events possibly related to the patch application (one localized erythema and one pruritus at the application site). One generalized skin eruption was recorded but assessed as unlikely related to treatment. No serious adverse event was observed.
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Assessment type |
Systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
21.0
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| Frequency threshold for reporting non-serious adverse events: 5% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: 3 (7.7%, 95%CI [1.6%-20.9%]) patients experienced at least one grade 1 or 2 adverse event with only two events possibly related to the patch application (one localized erythema and one pruritus at the application site). One generalized skin eruption was recorded but assessed as unlikely related to treatment. No serious adverse event was observed |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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25 Nov 2011 |
modification of criteria inclusion + prolongation of inclusion period |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
