A Study to Evaluate the Impact on Skin (Injection Site) Reactions of Taking an Antihistamine (Zyrtec®) or Placebo Prior to Daily Injections of Copaxone®.
Information source: Teva Pharmaceutical Industries
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Sclerosis
Intervention: Copaxone (glatiramer acetate injection) (Drug); Zyrtec (cetirizine hydrochloride) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Teva Pharmaceutical Industries Official(s) and/or principal investigator(s):
MerriKay Oleen-Burkey, Ph.D., Study Director, Affiliation: Teva Neuroscience, Inc.
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.
Clinical Details
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.
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Coordinated Clinical Research, La Jolla, California, United States
Neurological Center of South Florida, Miami, Florida, United States
Maine Neurology, Scarborough, Maine, United States
Bayside Neurology, New Bedford, Massachusetts, United States
Northern Michigan Neurology, Traverse City, Michigan, United States
Neurological Consultants of KC, Inc, Kansas City, Missouri, United States
Carolinas MS Center, Charlotte, North Carolina, United States
Ohio State University MS Center, Columbus, Ohio, United States
Riverhills Healthcare, Inc., Cincinnati, Ohio, United States
MS Center of Oklahoma, Oklahoma City, Oklahoma, United States
Hampton Roads Neurology, Newport News, Virginia, United States
Neurology and Neurosurgery Assoc. of Tacoma, Inc. PS, Tacoma, Washington, United States
Rockwood Clinic, PS, Spokane, Washington, United States
Additional Information
For more information about Multiple Sclerosis For more information about Teva Neuroscience, Inc.
Starting date: October 2004
Ending date: May 2006
Last updated: November 9, 2006
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