A Study to Evaluate the Impact of Using Warm Compress Prior to Daily I
An Open-Label, Randomized, Single Cross-over Study of Warm Compress Versus Usual Injection Site Preparation on Local Injection Site Reactions Among Persons With MS Who Perform Daily Injections of Copaxone®.
What it found
We found no results in the registry or in papers.
This trial finished 20 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Glatiramer acetate
Unknown
- Warm compress prior to injection of glatiramer acetate
What it measured
Main measures
The number of local injection site reactions (LISRs) noted at 5-minutes post-injection
2-week diaries kept by the patients for Period 1 and for Period 2
Safety
Other measures (1)
The total and partial number of LISRs noted at 2-minutes post-injection The total and partial number of LISRs noted immediately after injection
2-week diaries kept by the patients for Period 1 and for Period 2
Who could take part
Relapsing MS · 18 to 55
Show the full criteria
Inclusion criteria
1. Male or Female, 18 years or older, with a diagnosis of RRMS 2. Willing and able to complete all procedures and evaluations related to the study. 3. Willing to provide Informed Consent
Exclusion criteria
1. Taking any other immunomodulatory therapy in conjunction with Copaxone®. 2. Has a significant medical illness other than MS which may interfere with the assessment of endpoints or the subject's participation in the trial for the full duration of the study. 3. Any situation which the investigator or nurse feels may interfere with participation in the study. 4. Pregnant, or trying to become pregnant, or breast feeding during the study. 5. Previously participated in this 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 skin reactions with or without the use of warm compress prior to performing a Copaxone® injection.
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Met its main goal
History
Started
Aug 2005
Main results due
Dec 2005
Finished
Feb 2006