A Study to Evaluate the Impact on Skin (Injection Site) Reactions of Using Alcohol Wipes Prior to Daily Injections of Copaxone®.

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00220922
First received: September 20, 2005
Last updated: April 7, 2011
Last verified: April 2011

September 20, 2005
April 7, 2011
August 2004
October 2005   (final data collection date for primary outcome measure)
Total number of local injection site reactions (LISRs) noted at 5-minutes post-injection [ Time Frame: four weeks of Period 1 and the four weeks of Period 2 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00220922 on ClinicalTrials.gov Archive Site
The total number of LISRs noted at 2-minutes post-injection The total number of LISRs noted immediately after injection [ Time Frame: four weeks of Period 1 and the four weeks of Period 2 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
A Study to Evaluate the Impact on Skin (Injection Site) Reactions of Using Alcohol Wipes Prior to Daily Injections of Copaxone®.
An Open-Label, Randomized, Single Cross-Over Study of Isopropyl Alcohol Wipes Versus No Injection Site Preparation on Local Injection Site Reactions Among Persons With Multiple Sclerosis Who Perform Daily Injections of Copaxone®

This study is designed to compare injection site reactions with or without the use of alcohol wipes prior to performing the patients' daily Copaxone® injection.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Multiple Sclerosis
Procedure: Alcohol Wipes vs. No Alcohol Wipes
Other Name: Copaxone
  • Experimental: 1
    injection site reactions with the use of alcohol wipes prior to performing the patients' daily Copaxone® injection
    Intervention: Procedure: Alcohol Wipes vs. No Alcohol Wipes
  • Experimental: 2
    injection site reactions without the use of alcohol wipes prior to performing the patients' daily Copaxone® injection
    Intervention: Procedure: Alcohol Wipes vs. No Alcohol Wipes
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
February 2006
October 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or Female
  • 18 years of age or older
  • Diagnosis of RRMS
  • Beginning or recently (within 3 months) began self-injecting Copaxone® subcutaneously

Exclusion Criteria:

  • Unable to perform subcutaneous self-injection
  • Pregnant, or trying to become pregnant, or breast feeding during the study
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00220922
PM013
No
Thomas Smith, M.D., Vice President, Medical Affairs, Teva Neuroscience
Teva Neuroscience, Inc.
Not Provided
Study Director: MerriKay Oleen-Burkey, Ph.D. Teva Neuroscience, Inc.
Teva Pharmaceutical Industries
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP