A Study to Evaluate the Impact on Skin (Injection Site) Reactions of Taking an Antihistamine (Zyrtec®) or Placebo Prior to Daily Injections of Copaxone®.
Phase 4
Completed
- Conditions
- Multiple Sclerosis
- Interventions
- Registration Number
- NCT00240032
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Copaxone® with placebo glatiramer acetate with placebo - Copaxone® with Zyrtec glatiramer acetate injection with oral cetirizine hydrochloride -
- Primary Outcome Measures
Name Time Method Injection Site Reaction 5 weeks Injection site reaction after taking antihistamine
- Secondary Outcome Measures
Name Time Method