Anesthetic Topical Adhesive (Synera™) to Reduce Injection Pain With Subcutaneous Multiple Sclerosis Medications (OUCH)

March 14, 2018 updated by: Brown, Theodore R., M.D., MPH

Pilot Study of Anesthetic Topical Adhesive (Synera™) to Reduce Injection Pain With Subcutaneous Multiple Sclerosis Medications (OUCH)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Open-label prospective study of Synera to reduce injection pain in 30 patients with relapsing forms of Multiple Sclerosis taking interferon beta or glatiramer acetate. The duration will be 3-6 weeks (1-2 weeks of baseline observation followed by 2-4 weeks of on-drug observation), depending on which Multiple Sclerosis drug product is being studied. The study will include down-titration from 60 to 30 minutes of application to assess for any difference in responses. We define one primary outcome measure,"pain upon injection" by visual analog scale (VAS). Secondary measures will include 24-hour ratings of pain by VAS and 24-hour local injection site reaction (LISR) scale score.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Kirkland, Washington, United States, 98034
        • MS Center at Evergreen Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Anesthetic Topical Adhesive Synera

Anesthetic Topical Adhesive Synera. For subjects taking interferon beta subcutaneous (Betaseron, Extavia or Rebif) apply one patch 60 minutes prior to each injection (every-other day or three times per week) for two weeks, then 30 minutes prior for two weeks.

For subjects taking glatiramer acetate subcutaneous (Copaxone) apply one patch 60 minutes prior to each injection (daily) for one week and then 30 minutes prior for one week.
Drug: Anesthetic Topical Adhesive Synera

For subjects taking interferon beta subcutaneous (Betaseron, Extavia or Rebif) apply one patch 60 minutes prior to each injection (every-other day or three times per week) for two weeks, then 30 minutes prior for two weeks.

For subjects taking glatiramer acetate subcutaneous (Copaxone) apply one patch 60 minutes prior to each injection (daily) for one week and then 30 minutes prior for one week

Other Names:
  • Synera

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Rating
Time Frame: baseline and two weeks of treatment

Primary Outcome Measure

•Change from baseline in rating of pain upon injection, recorded immediately post-injection on a 0-10 Visual Analog Scale (VAS, 10 = worst pain, 0 = no pain)Pain upon injection, recorded immediately post-injection on a 0-10 Visual Analog scale (VAS, 10 = worst pain, 0 = no pain).
baseline and two weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Pain Rating
Time Frame: baseline and two weeks
Average Pain Rating over 24-hours, defined as the average injection-site pain over 24-hours on a 0-10 VAS (0 = no pain, 10 = worst pain).
baseline and two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brown, Theodore R., M.D., MPH

Investigators

  • Principal Investigator: Theodore R Brown, MD, MPH, Evergreen Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

April 2, 2013

First Submitted That Met QC Criteria

April 16, 2013

First Posted (Estimate)

April 18, 2013

Study Record Updates

Last Update Posted (Actual)

April 10, 2018

Last Update Submitted That Met QC Criteria

March 14, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRB 2012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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