Anesthetic Topical Adhesive (Synera™) to Reduce Injection Pain With Su
Pilot Study of Anesthetic Topical Adhesive (Synera™) to Reduce Injection Pain With Subcutaneous Multiple Sclerosis Medications (OUCH)
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Anesthetic Topical Adhesive Synera
Results by group
Pain Rating
baseline and two weeks of treatment
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Anesthetic Topical Adhesive Synera | 5.7 units on a scale | 3.2 (Standard Deviation) | 29 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Anesthetic Topical Adhesive Synera | 30 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Pain Rating
baseline and two weeks of treatment
Pain
Other measures (1)
Average Pain Rating
baseline and two weeks
PainSafety
Who could take part
MS (type not specified) · 18 and over
Show the full criteria
Inclusion criteria
* Confirmed diagnosis of Multiple Sclerosis based on McDonald or Poser criteria (no sub-type restrictions) * Aged >18 * Regular use of one of the follow Multiple Sclerosis medication treatments: interferon beta subcutaneous (15 subjects, Betaseron, Extavia or Rebif), or glatiramer acetate subcutaneous (15 subjects, Copaxone). * No change in disease modifying therapy in 60 days. * Mean score of ≥1.0 on Local Injection Site Reaction scale and Mean Pain Upon Injection score ≥4.0 during baseline period. * At least 4 valid diary entries over screening period. * No Multiple Sclerosis exacerbation for 60 days prior to screening. * Written informed consent
Exclusion criteria
* Females who are breast-feeding, pregnant or have potential to become pregnant during the course of the study (fertile and unwilling/unable to use effective contraceptive measures). * Cognitive deficits that would interfere with the subject's ability to give informed consent or perform study testing. * Concurrent application of any topical medication to treat injection site reactions from screening through final visit. * History of allergy to lidocaine, tetracaine or PABA (para-amino benzoic acid) containing products. * Patients receiving class 1 antiarrhythmic agents (i.e. tocainide, mexiletine) * Any other serious and/or unstable medical condition
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The purpose of this study is to see if applying an anesthetic topical adhesive, Synera®, will reduce the injection pain. Relieving injection site pain may improve the tolerability of Multiple Sclerosis medications. Study Hypothesis: Pre-medication with Synera will have a significant effect on pain ratings as measured by the visual analog scale and Local injection site reaction scale.
Papers
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History
Started
Mar 2013
Main results due
Mar 2015
Finished
Mar 2015
Results posted
Mar 2018