A Study to Evaluate the Impact on Skin (Injection Site) Reactions of T
A Double-Blind, Randomized, Placebo Controlled Study of An Oral Antihistamine on Local Injection Site Reactions Among Persons With Multiple Sclerosis Who Perform Daily Injections of Copaxone® Using Autoject® 2 for Glass Syringe.
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
Compared with
- Glatiramer acetate
Unknown
Placebo
- glatiramer acetate with placebo
What it measured
Main measures
Injection Site Reaction
5 weeks
Safety
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 \< 3months) began self-injecting Copaxone®
Exclusion criteria
* Taking any other immunomodulatory therapy in conjunction with Copaxone® * Unable to perform subcutaneous self-injection * Pregnant or trying to become pregnant, or breast feeding during the study * Previously participated in this study or in another clinical trial in the past 30 days
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 skin (injection site) reactions when an antihistamine (Zyrtec®) or placebo is taken prior to performing daily Copaxone® injections. Patients will be assigned (like a flip of a coin) to take either a placebo or an antihistamine (Zyrtec®) prior to performing their daily Copaxone® injections. The patient and physician will be unaware whether they are taking a placebo or antihistamine during the study.
Papers
Loading reviews and guidelines…
History
Started
Oct 2004
Main results due
Jun 2006
Finished
Jul 2006