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 has been completed.

First Received: October 13, 2005 Last Updated: April 3, 2009 History of Changes

Sponsor:	Teva Pharmaceutical Industries
Information provided by:	Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:	NCT00240032

Purpose

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.

Condition	Intervention	Phase
Multiple Sclerosis	Drug: Copaxone (glatiramer acetate injection) Drug: Zyrtec (cetirizine hydrochloride)	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
Official 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.

Resource links provided by NLM:

MedlinePlus related topics: Cold and Cough Medicines Multiple Sclerosis

Drug Information available for: Histamine Histamine phosphate Histamine dihydrochloride Cetirizine Cetirizine hydrochloride Copolymer 1

U.S. FDA Resources

Further study details as provided by Teva Pharmaceutical Industries:

Estimated Enrollment:	80
Study Start Date:	October 2004
Estimated Study Completion Date:	May 2006
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Detailed Description:

This is a double-blind, randomized, placebo controlled study with each patient randomized to either an oral antihistamine (Zyrtec®) or matching placebo.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00240032

Locations

United States, California
Coordinated Clinical Research
La Jolla, California, United States
United States, Florida
Neurological Center of South Florida
Miami, Florida, United States
United States, Maine
Maine Neurology
Scarborough, Maine, United States
United States, Massachusetts
Bayside Neurology
New Bedford, Massachusetts, United States
United States, Michigan
Northern Michigan Neurology
Traverse City, Michigan, United States
United States, Missouri
Neurological Consultants of KC, Inc
Kansas City, Missouri, United States
United States, North Carolina
Carolinas MS Center
Charlotte, North Carolina, United States
United States, Ohio
Ohio State University MS Center
Columbus, Ohio, United States
Riverhills Healthcare, Inc.
Cincinnati, Ohio, United States
United States, Oklahoma
MS Center of Oklahoma
Oklahoma City, Oklahoma, United States
United States, Virginia
Hampton Roads Neurology
Newport News, Virginia, United States
United States, Washington
Neurology and Neurosurgery Assoc. of Tacoma, Inc. PS
Tacoma, Washington, United States
Rockwood Clinic, PS
Spokane, Washington, United States

Sponsors and Collaborators

Teva Pharmaceutical Industries

Investigators

Study Director:

MerriKay Oleen-Burkey, Ph.D.

Teva Neuroscience, Inc.

More Information

Additional Information:

For more information about Multiple Sclerosis This link exits the ClinicalTrials.gov site

For more information about Teva Neuroscience, Inc. This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	PM014
Study First Received:	October 13, 2005
Last Updated:	April 3, 2009
ClinicalTrials.gov Identifier:	NCT00240032 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neurotransmitter Agents
Autoimmune Diseases
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Demyelinating Diseases
Immune System Diseases
Physiological Effects of Drugs
Nervous System Diseases
Adjuvants, Immunologic
Histamine Agents
Sclerosis
Anti-Allergic Agents

Cetirizine
Immunosuppressive Agents
Pharmacologic Actions
Copolymer 1
Multiple Sclerosis
Pathologic Processes
Histamine Antagonists
Therapeutic Uses
Demyelinating Autoimmune Diseases, CNS
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on February 09, 2010