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®.

A Double-Blind, Randomized, Placebo Controlled Study of An Oral Antihistamine on Local Injection Site Reactions Among Persons With Multiple Sclerosis Who Perform Daily Injections of Copaxone® Using Autoject® 2 for Glass Syringe.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	glatiramer acetate injection with oral cetirizine hydrochloride	Copaxone® injection 20 mg, Oral Zyrtec® 10 mg tablet
DRUG	glatiramer acetate with placebo	Copaxone® injection 20 mg, oral placebo

Timeline

• Start date: 2004-10-01
• Primary completion: 2006-06-01
• Completion: 2006-07-01
• First posted: 2005-10-17
• Last updated: 2011-04-11