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

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: glatiramer acetate injection with oral cetirizine hydrochloride Drug: glatiramer acetate with placebo	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
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:

Primary Outcome Measures:

Injection Site Reaction [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
Injection site reaction after taking antihistamine

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

Arms	Assigned Interventions
Active Comparator: Copaxone® with Zyrtec	Drug: glatiramer acetate injection with oral cetirizine hydrochloride Copaxone® injection 20 mg, Oral Zyrtec® 10 mg tablet Other Name: Copaxone®, Zyrtec®
Experimental: Copaxone® with placebo	Drug: glatiramer acetate with placebo Copaxone® injection 20 mg, oral placebo Other Name: Copaxone®

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

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

Responsible Party:	Thomas Smith, MD, VP Medical Affairs, Teva Neuroscience
ClinicalTrials.gov Identifier:	NCT00240032 History of Changes
Other Study ID Numbers:	PM014
Study First Received:	October 13, 2005
Last Updated:	April 7, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Histamine Antagonists
Cetirizine
Histamine H1 Antagonists

Copolymer 1
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Allergic Agents
Therapeutic Uses
Histamine H1 Antagonists, Non-Sedating
Adjuvants, Immunologic
Immunologic Factors
Immunosuppressive Agents

ClinicalTrials.gov processed this record on February 09, 2012