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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Copaxone® with Zyrtec | Active Comparator |
| |
| Copaxone® with placebo | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| glatiramer acetate injection with oral cetirizine hydrochloride | Drug | Copaxone® injection 20 mg, Oral Zyrtec® 10 mg tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Injection Site Reaction | Injection site reaction after taking antihistamine | 5 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MerriKay Oleen-Burkey, Ph.D. | Teva Neuroscience, Inc. | Study Director |
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| glatiramer acetate with placebo | Drug | Copaxone® injection 20 mg, oral placebo |
|
|
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068717 | Glatiramer Acetate |
| D017332 | Cetirizine |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D006919 | Hydroxyzine |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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