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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

glatiramer acetate injection with oral cetirizine hydrochloride

Drug

Copaxone® injection 20 mg, Oral Zyrtec® 10 mg tablet

Other names: Copaxone®, Zyrtec®

Glatiramer acetate with placebo

Drug

Copaxone® injection 20 mg, oral placebo

Other names: Copaxone®

Primary outcomes

Injection Site Reaction

Time frame: 5 weeks

Injection site reaction after taking antihistamine

Sponsors and collaborators

Lead sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Industry

Registry information

Official study title

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.

Important dates

Study start: 2004
Primary completion: 2006
Study completion: 2006
First posted: Oct 17, 2005
Registry last updated: Apr 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed