A Study to Evaluate the Impact on Skin (Injection Site) Reactions of Taking an Antihistamine (Zyrtec®) or Placebo Prior to Daily Injections of Copaxone®.

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.; Teva Pharmaceutical Industries
• Treatments: (T,G)-A-L; Cetirizine; Glatiramer Acetate; Histamine Antagonists; Histamine H1 Antagonists

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