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

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ClinicalTrials.gov Identifier: NCT01834586
Recruitment Status : Completed
First Posted : April 18, 2013
Results First Posted : March 13, 2018
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Brown, Theodore R., M.D., MPH

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Sclerosis
Intervention Drug: Anesthetic Topical Adhesive Synera
Enrollment 30
Recruitment Details multiple sclerosis clinic
Pre-assignment Details  
Arm/Group Title Anesthetic Topical Adhesive Synera
Hide Arm/Group Description

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.

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

Period Title: Overall Study
Started 30
Completed 29
Not Completed 1
Reason Not Completed
Adverse Event             1
Arm/Group Title Anesthetic Topical Adhesive Synera
Hide Arm/Group Description

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.

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

Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
<=18 years
0
   0.0%
Between 18 and 65 years
27
  90.0%
>=65 years
3
  10.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
51  (10.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
26
  86.7%
Male
4
  13.3%
Region of Enrollment   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
 100.0%
[1]
Measure Description: geographic location
1.Primary Outcome
Title Pain Rating
Hide Description

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).

Time Frame baseline and two weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
completing participants
Arm/Group Title Anesthetic Topical Adhesive Synera
Hide Arm/Group Description:

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.

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

Overall Number of Participants Analyzed 29
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.7  (3.2)
2.Secondary Outcome
Title Average Pain Rating
Hide Description 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).
Time Frame baseline and two weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anesthetic Topical Adhesive Synera
Hide Arm/Group Description:

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.

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

Overall Number of Participants Analyzed 29
Mean (Standard Deviation)
Unit of Measure: units on a scale
baseline 2.24  (1.74)
2 weeks, 30minute application 1.23  (1.23)
2 weeks, 60minute application 1.39  (1.49)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Anesthetic Topical Adhesive Synera
Hide Arm/Group Description

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.

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

All-Cause Mortality
Anesthetic Topical Adhesive Synera
Affected / at Risk (%)
Total   0/30 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Anesthetic Topical Adhesive Synera
Affected / at Risk (%) # Events
Total   0/30 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Anesthetic Topical Adhesive Synera
Affected / at Risk (%) # Events
Total   1/30 (3.33%)    
Nervous system disorders   
dizziness *  1/30 (3.33%)  2
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Theodore Brown
Organization: EvergreenHealth Multiple Sclerosis Center
Phone: 425-8995350
Responsible Party: Brown, Theodore R., M.D., MPH
ClinicalTrials.gov Identifier: NCT01834586     History of Changes
Other Study ID Numbers: TRB 2012
First Submitted: April 2, 2013
First Posted: April 18, 2013
Results First Submitted: January 24, 2018
Results First Posted: March 13, 2018
Last Update Posted: April 10, 2018