drugset / Trial / NCT00240032

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

NCT00240032

Phase 4 Completed 80 enrolled Teva Branded Pharmaceutical Products R&D, Inc.
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2004-10
Primary completion
2006-06
Completion
2006-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cetirizine Other / unclassified 10 mg Oral
Comparator Glatiramer Acetate Small molecule 20 mg

Indications