Neuropathic PainsPhase 2NCT01314300
Lidocaine 5% Plasters (Versatis® 5%) in Pediatric Neuropathic Pains and Vasoocclusive Sickle Cell Crisis Pains
A Phase 2 study testing Lidocaine in people with Neuropathic Pains and Vasoocclusive Sickle Cell Crises Pains, run by Centre Leon Berard at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 21 years
- Conditions the study is for
- Neuropathic Pains, Vasoocclusive Sickle Cell Crises Pains
- What is being tested?
- Lidocaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesFrance
- Study dates
- Mar 2011to Jul 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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:
Show all 15Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
IHOP
Lyon, 69008
Centre Médico-chirurgical de Réadaptation des Massues
Lyon
About this study
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
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.
Read the 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:
- 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.
- to evaluate safety of lidocaine 5% plaster (VERSATIS® 5%) in these same indications.
- Being tested
- Lidocaine
- Keywords
- Child, adolescent, young adult, Plaster, Lidocaine
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Also called Versatis® 5%
Lidocaine 5% plaster
| Study group | Role | What they receive |
|---|---|---|
| Efficacy of Lidocaine 5% plaster | Experimental | Treatment of pain by Lidocaine 5% plaster Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lidocaine 5% plaster efficacy between t0 and t12
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).
Measured: 12 hours
Secondary outcomes (2)
Lidocaine 5% plaster efficacy between t0 and t6
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).
Measured: 6 hours
Lidocaine 5% plaster safety
Rate of patients with local and/or general adverse event as graded using NCI-CTCAE V4.0
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neuropathic PainsStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Perrine MAREC-BERARD, M.D., Principal investigator, IHOP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01314300
- Sponsor's protocol ID
- VERSATIS
- Status last verified
- Oct 2014
- First submitted
- 11 Mar 2011
- Last updated
- 30 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Walker SM. Pain in children: recent advances and ongoing challenges. Br J Anaesth. 2008 Jul;101(1):101-10. doi: 10.1093/bja/aen097. Epub 2008 Apr 21.
PubMed 18430745Walco GA, Dworkin RH, Krane EJ, LeBel AA, Treede RD. Neuropathic pain in children: Special considerations. Mayo Clin Proc. 2010 Mar;85(3 Suppl):S33-41. doi: 10.4065/mcp.2009.0647.
PubMed 20194147Garnock-Jones KP, Keating GM. Lidocaine 5% medicated plaster: a review of its use in postherpetic neuralgia. Drugs. 2009 Oct 22;69(15):2149-65. doi: 10.2165/11203220-000000000-00000.
PubMed 19791831Rowbotham MC, Davies PS, Verkempinck C, Galer BS. Lidocaine patch: double-blind controlled study of a new treatment method for post-herpetic neuralgia. Pain. 1996 Apr;65(1):39-44. doi: 10.1016/0304-3959(95)00146-8.
PubMed 8826488
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01314300
- Acronym / sponsor ID
- VERSATIS
- Keywords
- Child, adolescent, young adult, Plaster, Lidocaine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 14 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- to evaluate safety of lidocaine 5% plaster (VERSATIS® 5%) in these same indications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Efficacy of Lidocaine 5% plaster | Experimental | Drug: LidocaineTreatment of pain by Lidocaine 5% plaster |
Who may qualify
- Ages
- 6 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 6 years <= Age <= 21 years
- With:
- Covered by a medical insurance
- Signed written informed consent form(for minors unemancipated, permission will be given by holders of parental authority)
Key exclusion criteria (15 listed)
- Clinical condition not permitting data reporting (impaired consciousness)
- Painful area with an surface greater than:
- Existence of a statement for the use of lidocaine 5% (VERSATIS® 5%) plaster as defined in the summary of product characteristics, as:
- Severe cardiac insufficiency
- Severe renal insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LidocaineAlso: Versatis® 5%Lidocaine 5% plaster | Drug | Efficacy of Lidocaine 5% plaster |
Primary outcome
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).
2 secondary outcomes
Lidocaine 5% plaster efficacy between t0 and t6
Time frame: 6 hours
Lidocaine 5% plaster safety
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2014.
- Results publication: PubMed 18430745Walker SM. Pain in children: recent advances and ongoing challenges. Br J Anaesth. 2008 Jul;101(1):101-10. doi: 10.1093/bja/aen097. Epub 2008 Apr 21.
- Results publication: PubMed 20194147Walco GA, Dworkin RH, Krane EJ, LeBel AA, Treede RD. Neuropathic pain in children: Special considerations. Mayo Clin Proc. 2010 Mar;85(3 Suppl):S33-41. doi: 10.4065/mcp.2009.0647.
- Results publication: PubMed 19791831Garnock-Jones KP, Keating GM. Lidocaine 5% medicated plaster: a review of its use in postherpetic neuralgia. Drugs. 2009 Oct 22;69(15):2149-65. doi: 10.2165/11203220-000000000-00000.
- Results publication: PubMed 8826488Rowbotham MC, Davies PS, Verkempinck C, Galer BS. Lidocaine patch: double-blind controlled study of a new treatment method for post-herpetic neuralgia. Pain. 1996 Apr;65(1):39-44. doi: 10.1016/0304-3959(95)00146-8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Perrine MAREC-BERARD, M.D. principal investigator
IHOP
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lidocaine in people with Neuropathic Pains and Vasoocclusive Sickle Cell Crises Pains, run by Centre Leon Berard at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lidocaine 5% plaster efficacy between t0 and t12 (time frame: 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01314300, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2014.