A Study to Evaluate the Impact on Skin (Injection Site) Reactions of U
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®
What it found
We found no results in the registry or in papers.
This trial finished 21 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Alcohol Wipes vs. No Alcohol Wipes
What it measured
Main measures
Total number of local injection site reactions (LISRs) noted at 5-minutes post-injection
four weeks of Period 1 and the four weeks of Period 2
Safety
Other measures (1)
The total number of LISRs noted at 2-minutes post-injection The total number of LISRs noted immediately after injection
four weeks of Period 1 and the four weeks of Period 2
Who could take part
Relapsing MS · 18 and over
Show the full criteria
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Aug 2004
Main results due
Oct 2005
Finished
Feb 2006