A Study to Evaluate the Impact on Skin (Injection Site) Reactions of Taking an Antihistamine (Zyrtec®) or Placebo Prior to Daily Injections of Copaxone®.
NCT ID: NCT00240032
Last Updated: 2011-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
80 participants
INTERVENTIONAL
2004-10-31
2006-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Copaxone® with Zyrtec
glatiramer acetate injection with oral cetirizine hydrochloride
Copaxone® injection 20 mg, Oral Zyrtec® 10 mg tablet
Copaxone® with placebo
glatiramer acetate with placebo
Copaxone® injection 20 mg, oral placebo
Interventions
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glatiramer acetate injection with oral cetirizine hydrochloride
Copaxone® injection 20 mg, Oral Zyrtec® 10 mg tablet
glatiramer acetate with placebo
Copaxone® injection 20 mg, oral placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18 years of age or older
* Diagnosis of RRMS
* Beginning or recently (within \< 3months) began self-injecting Copaxone®
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Responsible Party
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Teva Neuroscience
Principal Investigators
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MerriKay Oleen-Burkey, Ph.D.
Role: STUDY_DIRECTOR
Teva Neuroscience, Inc.
Other Identifiers
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PM014
Identifier Type: -
Identifier Source: org_study_id
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