NCT01834586

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Brown, Theodore R., M.D., MPH · Individual
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-03-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2013-04-18
• Last updated: 2018-04-10
• Results posted: 2018-03-13

Locations

1 site across 1 country: United States